This study aims to determine the safety and pharmacokinetics of multiple ascending doses of Lucid-21-302 in healthy adult participants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
16
Capsule containing a small molecule inhibitor of hypercitrullination
Capsule containing only Silicified Microcrystalline Cellulose
Cmax Clinical Research
Adelaide, Maryland, Australia
Incidence, severity and relationship of Adverse Events (AEs)
Safety Outcome Measure
Time frame: Up to 15 days
Incidence of Serious AEs (SAEs) and suspected unexpected SAEs
Safety Outcome Measure
Time frame: Up to 15 days
Number of discontinuations due to AEs
Safety Outcome Measure
Time frame: Up to 15 days
Clinically significant changes from baseline in complete blood count
Safety blood test measured by a laboratory using a reference range
Time frame: Up to 15 days
Clinically significant changes from baseline in blood coagulation
Safety blood test measured by a laboratory using a reference range
Time frame: Up to 15 days
Clinically significant changes from baseline in blood biochemistry
Safety blood test measured by a laboratory using a reference range
Time frame: Up to 15 days
Clinically significant changes from baseline in urinalysis
Safety urine test measured by a laboratory using a reference range
Time frame: Up to 15 days
Clinically significant changes from baseline in physical exam
Safety Outcome Measure, clinical exam performed by a licensed physician
Time frame: Up to 15 days
Clinically significant changes from baseline in systolic blood pressure
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Safety Outcome Measure, measured in mmHg
Time frame: Up to 15 days
Clinically significant changes from baseline in diastolic blood pressure
Safety Outcome Measure, measured in mmHg
Time frame: Up to 15 days
Clinically significant changes from baseline in heart rate
Safety Outcome Measure, measured in beats per minute
Time frame: Up to 15 days
Clinically significant changes from baseline in respiratory rate
Safety Outcome Measure, measured in breaths per minute
Time frame: Up to 15 days
Clinically significant changes from baseline in tympanic temperature
Safety Outcome Measure, measured in degrees Celcius
Time frame: Up to 15 days
Clinically significant changes from baseline in 12-lead electrocardiogram (ECG)
Safety Outcome Measure, measured using a standard ECG machine
Time frame: Up to 15 days
Clinically significant changes from baseline in patient health questionnaire (PHQ-9)
Safety Outcome Measure, PHQ-9 is a depression scale with scores ranging from 0 to 27 with higher scores indicating more depressive symptoms
Time frame: Up to 15 days
Clinically significant changes from baseline in generalized anxiety disorder questionnaire (GAD7)
Safety Outcome Measure, GAD7 is an anxiety scale with scores ranging from 0 to 21 with higher scores indicating more anxiety symptoms
Time frame: Up to 15 days
Clinically significant changes from baseline in Columbia suicide severity rating scale (C-SSRS)
Safety Outcome Measure, C-SSRS is an assessment tool that measures suicidal ideation and behavior. It consists of ten yes or no questions with yes answers indicating more thoughts of suicidality.
Time frame: Up to 15 days
Clinically significant changes from baseline in neurological exam
Safety Outcome Measure, neurological exam performed by a licensed physician
Time frame: Up to 15 days
AUC from time zero to 24 hours
PK characteristic on Day 1
Time frame: Day1 (pre-dose to 24 hours post-dose)
AUC from time zero to the last non-zero concentration
PK characteristic on Day 1
Time frame: Day1 (pre-dose to 24 hours post-dose)
Maximum concentration (Cmax)
PK characteristic on Day 1
Time frame: Day1 (pre-dose to 24 hours post-dose)
Time to maximum concentration (Tmax)
PK characteristic on Day 1
Time frame: Day1 (pre-dose to 24 hours post-dose)
AUC from time zero to the end of the dosing period
PK characteristic on Day 4
Time frame: Day 4 (pre-dose to 24 hours post-dose)
AUC from time zero to the last non-zero concentration
PK characteristic on Day 4
Time frame: Day 4 (pre-dose to 24 hours post-dose)
Minimum concentration (Cmin)
PK characteristic on Day 4
Time frame: Day 4 (pre-dose to 24 hours post-dose)
Maximum concentration (Cmax)
PK characteristic on Day 4
Time frame: Day 4 (pre-dose to 24 hours post-dose)
Time to maximum concentration (Tmax)
PK characteristic on Day 4
Time frame: Day 4 (pre-dose to 24 hours post-dose)
AUC from time zero to the last non-zero concentration
PK characteristic on Day 7
Time frame: Day 7 (pre-dose to 48 hours post-dose)
Maximum concentration (Cmax)
PK characteristic on Day 7
Time frame: Day 7 (pre-dose to 48 hours post-dose)
Time to maximum concentration (Tmax)
PK characteristic on Day 7
Time frame: Day 7 (pre-dose to 48 hours post-dose)
Minimum concentration (Cmin)
PK characteristic on Day 7
Time frame: Day 7 (pre-dose to 48 hours post-dose)
AUC from time zero to infinity
PK characteristic on Day 7
Time frame: Day 7 (pre-dose to 48 hours post-dose)
Average concentration at steady state (Css ave)
PK characteristic on Day 7
Time frame: Day 7 (pre-dose to 48 hours post-dose)
AUC from time zero to the end of the dosing period
PK characteristic on Day 7
Time frame: Day 7 (pre-dose to 48 hours post-dose)
Residual area
PK characteristic on Day 7
Time frame: Day 7 (pre-dose to 48 hours post-dose)
Elimination half-life
PK characteristic on Day 7
Time frame: Day 7 (pre-dose to 48 hours post-dose)
Elimination rate constant
PK characteristic on Day 7
Time frame: Day 7 (pre-dose to 48 hours post-dose)
Apparent clearance of drug at steady state
PK characteristic on Day 7
Time frame: Day 7 (pre-dose to 48 hours post-dose)
Apparent volume of distribution at steady state
PK characteristic on Day 7
Time frame: Day 7 (pre-dose to 48 hours post-dose)
AUC accumulation ratio
PK characteristic
Time frame: Day 1 to Day 7
Maximum concentration (Cmax) accumulation ratio
PK characteristic
Time frame: Day 1 to Day 7
Trough concentration
PK characteristic
Time frame: Day 2 to Day 7