Study of Safety and Drug Levels of CCI15106 Inhalation Powder in Healthy Adults and Adults With Moderate Chronic Obstructive Pulmonary Disease. Study of CCI15106 Levels in People Standing Near the Person Inhaling the Drug

Part 1 Cohort A: Number of Participants With Non-serious Adverse Events (NSAEs) and Serious Adverse Events (SAEs) in CCI15106

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician. Safety population comprised of all participants who received at least one dose of study treatment during the study.

Time frame: Up to 51 days

Part 1 Cohort B: Number of Participants With NSAEs and SAEs in CCI15106

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician.

Time frame: Up to 46 days

Part 1 Cohort C: Number of Participants With NSAEs and SAEs in Bystanders

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician.

Time frame: Up to 46 days

Part 2 Cohort A: Number of Participants With NSAEs and SAEs

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician.

Time frame: Up to 33 days

Part 2 Cohort B: Number of Participants With NSAEs and SAEs

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician.

Time frame: Up to 46 days

Part 1: Number of Participants With Hematology Values of Potential Clinical Importance (PCI) in CCI15106

PCI ranges for the hematology parameters were as follows: hematocrit (high: \>0.54 proportion of red blood cell \[RBC\] in blood for male, \>0.54 proportion of RBC in blood for female), hemoglobin (high: \>180 grams \[g\]/L in male, \>180 g/L in female), lymphocytes (low: \<0.8 10\^9/L), neutrophil count (low: \<1.5 10\^9/L) and platelet count (low: \<100 10\^9/L and high: 550 10\^9/L). Data for the participants with high and low values has been reported.

Time frame: Up to 51 days

Part 1: Number of Participants With Hematology Values of PCI in Bystanders

PCI ranges for the hematology parameters were as follows: hematocrit (high: \>0.54 proportion of RBC in blood for male, \>0.54 proportion of RBC in blood for female), hemoglobin (high: \>180 g/L in male, \>180 g/L in female), lymphocytes (low: \<0.8 10\^9/L), neutrophil count (low: \<1.5 10\^9/L) and platelet count (low: \<100 10\^9/L and high: 550 10\^9/L). Data for the participants with high and low values has been reported.

Time frame: Up to 46 days

Part 2: Number of Participants With Hematology Values of PCI

PCI ranges for the hematology parameters were as follows: hematocrit (high: \>0.54 proportion of RBC in blood for male, \>0.54 proportion of RBC in blood for female), hemoglobin (high: \>180 g/L in male, \>180 g/L in female), lymphocytes (low: \<0.8 10\^9/L), neutrophil count (low: \<1.5 10\^9/L) and platelet count (low: \<100 10\^9/L and high: 550 10\^9/L). Data for the participants with high and low values has been reported.

Time frame: Up to 46 days

Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106

PCI ranges for the clinical chemistry parameters were as follows: albumin (low: \<30 millimole per liter \[mmol/L\]), calcium (low: \<2 mmol/L and high: \>2.75 mmol/L), glucose (low: \<3 mmol/L and high: \>9 mmol/L), potassium (low: \<3 mmol/L and high: \>5.5 mmol/L) and sodium (low: \<130 mmol/L and high: \>150 mmol/L). Data for the participants with high and low values has been reported.

Time frame: Up to 51 days

Part 1: Number of Participants With Clinical Chemistry Values of PCI in Bystanders

PCI ranges for the clinical chemistry parameters were as follows: albumin (low: \<30 mmol/L), calcium (low: \<2 mmol/L and high: \>2.75 mmol/L), glucose (low: \<3 mmol/L and high: \>9 mmol/L), potassium (low: \<3 mmol/L and high: \>5.5 mmol/L) and sodium (low: \<130 mmol/L and high: \>150 mmol/L). Data for the participants with high and low values has been reported.

Time frame: Up to 46 days

Part 2: Number of Participants With Clinical Chemistry Values of PCI

PCI ranges for the clinical chemistry parameters were as follows: albumin (low: \<30 mmol/L), calcium (low: \<2 mmol/L and high: \>2.75 mmol/L), glucose (low: \<3 mmol/L and high: \>9 mmol/L), potassium (low: \<3 mmol/L and high: \>5.5 mmol/L) and sodium (low: \<130 mmol/L and high: \>150 mmol/L). Data for the participants with high and low values has been reported.

Time frame: Up to 46 days

Part 1 Cohort A: Potential of Hydrogen (pH) Value by Visit- CCI15106 60 mg SD

Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).

Time frame: Baseline (Day -1) and Day 2

Part 1 Cohort A: pH Value by Visit- CCI15106 120 mg SD

Urine sample was collected from participants at indicated time point for analysis of pH.

Time frame: Day 5

Part 1 Cohort A: pH Value by Visit- CCI15106 30 mg BID

Urine samples were collected from participants at indicated time points for analysis of pH.

Time frame: Days 12 and 22

Part 1 Cohort B: pH Value by Visit- CCI15106 60 mg BID

Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).

Time frame: Baseline (Day -1), Days 7 and 15

Part 1: pH Value by Visit- Placebo

Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).

Time frame: Baseline (Day -1), Days 2, 5, 7, 12, 15 and 22

Part 1 Cohort C: pH Value by Visit- CCI15106 in Bystanders

Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).

Time frame: Baseline (Day -1), Days 7 and 15

Part 2 Cohort A: pH Value by Visit- CCI15106

Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).

Time frame: Baseline (Day -1) and Day 2

Part 2 Cohort B: pH Value by Visit- CCI15106 60 mg BID

Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).

Time frame: Baseline (Day -1), Days 7 and 15

Part 1 Cohort A: Specific Gravity Value by Visit- CCI15106 60 mg SD

Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).

Time frame: Baseline (Day -1) and Day 2

Part 1 Cohort A: Specific Gravity Value by Visit- CCI15106 120 mg SD

Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine sample was collected from participants at indicated time point for analysis of specific gravity.

Time frame: Day 5

Part 1 Cohort A: Specific Gravity Value by Visit- CCI15106 30 mg BID

Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity.

Time frame: Days 12 and 22

Part 1 Cohort B: Specific Gravity Value by Visit- CCI15106 60 mg BID

Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of Specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).

Time frame: Baseline (Day -1), Days 7 and 15

Part 1: Specific Gravity Value by Visit- Placebo

Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of Specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).

Time frame: Baseline (Day -1), Days 2, 5, 7, 12, 15 and 22

Part 1 Cohort C: Specific Gravity Value by Visit- CCI15106 in Bystanders

Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).

Time frame: Baseline (Day -1), Days 7 and 15

Part 2 Cohort A: Specific Gravity Value by Visit- CCI15106

Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).

Time frame: Baseline (Day -1) and Day 2

Part 2 Cohort B: Specific Gravity Value by Visit- CCI15106 60 mg BID

Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).

Time frame: Baseline (Day -1), Days 7 and 15

Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106

PCI ranges for the ECG parameters were as follows: absolute QTc interval \>450 and \<480, \>=480 and \<500, \>=500 milliseconds (msec), absolute PR interval \<110 and \>220 msec and absolute QRS interval \<75 and \>110 msec. QTcF=Frederica's QT interval corrected for heart rate; QTcB=Bazett's QT interval corrected for heart rate. Data for worst case post-Baseline has been reported.

Time frame: Up to 51 days

Part 1: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI in Bystander

PCI ranges for the ECG parameters were as follows: absolute QTc interval \>450 and \<480, \>=480 and \<500, \>=500 msec, absolute PR interval \<110 and \>220 msec and absolute QRS interval \<75 and \>110 msec. Data for worst case post-Baseline has been reported.

Time frame: Up to 46 days

Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI

PCI ranges for the ECG parameters were as follows: absolute QTc interval \>450 and \<480, \>=480 and \<500, \>=500 msec, absolute PR interval \<110 and \>220 msec and absolute QRS interval \<75 and \>110 msec. Data for worst case post-Baseline has been reported.

Time frame: Up to 46 days

Part 1: Number of Participants With Abnormal Telemetry Findings

Continuous cardiac telemetry was performed from approximately 0.5 hour (pre-dose) to 4 hours post-dose. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.

Time frame: Days 1, 3, 6, 7, 12 and 18: 0.5 hour (pre-dose) to 4 hours post-dose

Part 2: Number of Participants With Abnormal Telemetry Findings

Continuous cardiac telemetry was performed from approximately 0.5 hour (pre-dose) to 4 hours post-dose. Abnormal findings were categorized as CS and NCS. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.

Time frame: Days 1, 7, 12 and 13: 0.5 hour (pre-dose) to 4 hours post-dose

Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points

FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using standard spirometry. Percent predicted FEV1 was calculated as: Percent predicted FEV1=(maximum FEV1 divided by predicted normal FEV1)\*100.

Time frame: Days 1, 3, 6 and 19: pre-dose, 0.25, 0.5, 1 and 4 hours post-dose; Days 8, 11 and 16: pre-dose and 4 hours post-dose; Day 14: pre-dose, 0.5, 1 and 4 hours post-dose

Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points

FVC is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FVC was measured using standard spirometry. Percent predicted FVC was calculated as: Percent predicted FVC=(maximum FVC divided by predicted normal FVC)\*100.

Time frame: Days 1, 3, 6 and 19: pre-dose, 0.25, 0.5, 1 and 4 hours post-dose; Days 8, 11 and 16: pre-dose and 4 hours post-dose; Day 14: pre-dose, 0.5, 1 and 4 hours post-dose

Part 2: Percent Predicted FEV1 at Indicated Time Points

FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using standard spirometry. Percent predicted FEV1 was calculated as: Percent predicted FEV1=(maximum FEV1 divided by predicted normal FEV1)\*100.

Time frame: Day 1 and 14: pre-dose, 0.25, 0.5, 1 and 4 hours post-dose; Days 3, 6 and 11: pre-dose and 4 hours post-dose

Part 2: Percent Predicted FVC at Indicated Time Points

FVC is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FVC was measured using standard spirometry. Percent predicted FVC was calculated as: Percent predicted FVC=(maximum FVC divided by predicted normal FVC)\*100.

Time frame: Day 1 and 14: pre-dose, 0.25, 0.5, 1 and 4 hours post-dose; Days 3, 6 and 11: pre-dose and 4 hours post-dose

Part 1: Number of Participants With Vital Signs Values of PCI

PCI ranges for the vital signs parameters were as follows: systolic blood pressure (SBP) \<85 and \>160 millimeters of mercury (mmHg), diastolic blood pressure (DBP) \<45 and \>100 mmHg and heart rate \<40 and \>110 beats per minute (bpm). Data for the participants with high and low values has been reported.

Time frame: Up to 51 days

Part 1: Number of Participants With Vital Signs Values of PCI in Bystanders

PCI ranges for the vital signs parameters were as follows: SBP \<85 and \>160 mmHg, DBP \<45 and \>100 mmHg and heart rate \<40 and \>110 bpm. Data for the participants with high and low values has been reported.

Time frame: Up to 46 days

Part 2: Number of Participants With Vital Signs Values of PCI

PCI ranges for the vital signs parameters were as follows: SBP \<85 and \>160 mmHg, DBP \<45 and \>100 mmHg and heart rate \<40 and \>110 bpm. Data for the participants with high and low values has been reported.

Time frame: Up to 46 days

Part 1 Cohort A: Area Under the Curve (AUC) From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-t]) After Single Dose Administration of CCI15106 60 mg on Day 1

Blood samples were collected to evaluate the pharmacokinetics (PKs) of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-t) data. PK population consisted of participants who received at least one dose of study treatment and who undergo plasma PK sampling and had at least one post-dose concentration result.

Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose

Part 1 Cohort A: AUC(0-t) After Single Dose Administration of CCI15106 120 mg on Day 3

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of AUC(0-t) data.

Time frame: Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose

Part 2 Cohort A: AUC(0-t) After Single Dose Administration of CCI15106 60 mg on Day 1

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-t) data.

Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose

Part 1 Cohort A: Maximum Observed Plasma Concentration (Cmax) After Single Dose Administration of CCI15106 60 mg on Day 1

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of Cmax data.

Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose

Part 1 Cohort A: Cmax After Single Dose Administration of CCI15106 120 mg on Day 3

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of Cmax data.

Time frame: Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose

Part 2 Cohort A: Cmax After Single Dose Administration of CCI15106 60 mg on Day 1

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of Cmax data.

Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose

Part 1 Cohort A: Time of Maximum Concentration (Tmax) After Single Dose Administration of CCI15106 60 mg on Day 1

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of tmax data.

Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose

Part 1 Cohort A: Tmax After Single Dose Administration of CCI15106 120 mg on Day 3

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of tmax data.

Time frame: Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose

Part 2 Cohort A: Tmax After Single Dose Administration of CCI15106 60 mg on Day 1

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of tmax data.

Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose

Part 1 Cohort A: AUC From Time Zero to Infinity (AUC[0-infinity]) After Single Dose Administration of CCI15106 60 mg on Day 1

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-infinity) data.

Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose

Part 1 Cohort A: AUC(0-infinity) After Single Dose Administration of CCI15106 120 mg on Day 3

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of AUC(0-infinity) data.

Time frame: Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose

Part 2 Cohort A: AUC(0-infinity) After Single Dose Administration of CCI15106 60 mg on Day 1

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-infinity) data.

Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose

Part 1 Cohort A: Elimination Half-life (t1/2) After Single Dose Administration of CCI15106 60 mg on Day 1

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of t1/2 data.

Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose

Part 1 Cohort A: t1/2 After Single Dose Administration of CCI15106 120 mg on Day 3

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of t1/2 data.

Time frame: Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose

Part 2 Cohort A: t1/2 After Single Dose Administration of CCI15106 60 mg on Day 1

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of t1/2 data.

Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose

Part 1 Cohort A: Clearance (CL/F) After Single Dose Administration of CCI15106 60 mg on Day 1

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of CL/F data.

Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose

Part 1 Cohort A: CL/F After Single Dose Administration of CCI15106 120 mg on Day 3

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of CL/F data.

Time frame: Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose

Part 2 Cohort A: CL/F After Single Dose Administration of CCI15106 60 mg on Day 1

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of CL/F data.

Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose

Part 1 Cohort A: AUC From Time Zero to End of Dosing Interval (AUC[0-tau]) After Repeated Dose Administration of CCI15106 30 mg

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of AUC(0-tau) data.

Time frame: Day 6: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 19: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose

Part 1 Cohort B: AUC(0-tau) After Repeated Dose Administration of CCI15106 60 mg

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of AUC(0-tau) data.

Time frame: Days 1 and 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose

Part 2 Cohort B: AUC(0-tau) After Repeated Dose Administration of CCI15106 60 mg

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of AUC(0-tau) data.

Time frame: Days 1 and 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose

Part 1 Cohort A: Cmax After Repeated Dose Administration of CCI15106 30 mg

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of Cmax data.

Time frame: Day 6: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 19: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose

Part 1 Cohort B: Cmax After Repeated Dose Administration of CCI15106 60 mg

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of Cmax data.

Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose

Part 2 Cohort B: Cmax After Repeated Dose Administration of CCI15106 60 mg

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of Cmax data.

Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose

Part 1 Cohort A: Tmax After Repeated Dose Administration of CCI15106 30 mg

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of tmax data.

Time frame: Day 6: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 19: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose

Part 1 Cohort B: Tmax After Repeated Dose Administration of CCI15106 60 mg

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of tmax data.

Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose

Part 2 Cohort B: Tmax After Repeated Dose Administration of CCI15106 60 mg

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of tmax data.

Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose

Part 1 Cohort A: t1/2 After Repeated Dose Administration of CCI15106 30 mg

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of t1/2 data.

Time frame: Day 6: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 19: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose

Part 1 Cohort B: t1/2 After Repeated Dose Administration of CCI15106 60 mg

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of t1/2 data.

Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose

Part 2 Cohort B: t1/2 After Repeated Dose Administration of CCI15106 60 mg

Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of t1/2 data.

Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose

Part 1: Concentration of CCI15106 in Plasma of Bystanders: Cohort C

Blood samples were collected from bystanders 15 minutes after dosing at indicated time points. Bystander PK population consisted of participants who were present at least once in the room with the participant receiving the dose, undergo plasma PK sampling and had post-dose concentration result.

Time frame: Days 1, 7 and 14: pre-dose, 15 minutes post-dose

Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C

Personal exposure air samples were collected on filters placed on each bystander after the first daily dose at indicated time points. The filters were used to measure CCI15106 concentration in the person's breathing zone. Fixed location concentrations were measured near window, near door, back to wall and facing wall in the dosing room over 15 minutes post-dose. Each bystander had a filter attached to their study clothing. The filters were measured for CCI15106. This was a single measurement from the filter for each bystsander. The locations (near window, near door, back to wall and facing wall) were just to record where the bystander was located in the room.

Time frame: Days 1, 7 and 14: 15 minutes post-dose

Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C

Static air samples were collected on filters within air pumps positioned in two locations (bench and corner) in the room. Sampling devices attached to sampling pumps were used to measure CCI15106 concentration. Fixed location concentrations were measured in corner of room and on bench at back of room over 20 minutes and 60 minutes post-dosing.

Time frame: Days 1, 7 and 14: 20 and 60 minutes post-dose