First-in-Human Phase 1, Single-Center, Randomized, Blinded, Placebo-Controlled Trial in Healthy Adults to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Oral AN2-502998
First-in-human Phase 1, Single-Center, Randomized, Blinded, Placebo-Controlled Trial in Healthy Adults to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Oral AN2-502998 Part A (SAD; Groups SAD1-SAD6): Part A is the Single Ascending Dose (SAD) portion of the trial that will be conducted in approximately 48 healthy adults in approximately 6 groups. Eight participants in each group will be randomized in a 6:2 ratio to receive a single dose of AN2-502998 or matching PBO, respectively (6 AN2-502998:2 PBO). Part B (MAD; Groups MAD1-MAD3): Part B is the Multiple Ascending Dose (MAD) portion of the trial that will be conducted in approximately 24 healthy adults in approximately 3 groups. Eight participants in each group will be randomized in a 6:2 ratio to receive multiple doses of AN2-502998 or matching PBO (6 AN2 502998:2 PBO) QD for 10 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
72
Oral Capsule
Oral Capsule
Nucleus Network
Melbourne, Victoria, Australia
RECRUITINGEvaluate the Incidence of Treatment Emergent Adverse Events at Baseline and Through Study Completion for a Single Dose
Incidence, relatedness, and severity of adverse events
Time frame: Day 1 through last follow-up (9 Days after single dose)
Evaluate Physical Examination Abnormalities from Baseline Through Study Completion for a Single Dose
Incidence of physical exam abnormalities
Time frame: Day 1 through last follow-up (9 Days after single dose)
Evaluate Change in Vital Signs from Baseline Through Study Completion for a Single Dose
Incidence of changes in blood pressure, pulse, respiratory rate, and temperature
Time frame: Day 1 through last follow-up (9 Days after single dose)
Evaluate Changes in 12-lead ECG Measurements from Baseline Through Study Completion for a Single Dose
Incidence of changes in 12-lead ECG parameters from baseline
Time frame: Day 1 through last follow-up (9 Days after single dose)
Evaluate Changes in Clinical Laboratory Tests from Baseline Through Study Completion for a Single Dose
Incidence of changes in clinical laboratory measurements from baseline
Time frame: Day 1 through last follow-up (9 Days after single dose)
Evaluate the Incidence of Treatment Emergent Adverse Events at Baseline and Through Study Completion for Multiple Doses
Incidence, relatedness, and severity of adverse events
Time frame: Day 1 through last follow-up (10 Days after last dose)
Evaluate Physical Examination Abnormalities from Baseline Through Study Completion for Multiple Doses
Incidence of physical exam abnormalities
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Time frame: Day 1 through last follow-up (10 Days after last dose)
Evaluate Change in Vital Signs from Baseline Through Study Completion for Multiple Doses
Incidence of changes in blood pressure, pulse, respiratory rate, and temperature
Time frame: Day 1 through last follow-up (10 Days after last dose)
Evaluate Changes in 12-lead ECG Measurements from Baseline Through Study Completion for Multiple Doses
Incidence of changes in 12-lead ECG parameters from baseline
Time frame: Day 1 through last follow-up (10 Days after last dose)
Evaluate Changes in Clinical Laboratory Tests from Baseline Through Study Completion for Multiple Doses
Incidence of changes in clinical laboratory measurements from baseline
Time frame: Day 1 through last follow-up (10 Days after last dose)
Characterize the PK Profile of AN2-502998: Maximum Plasma Concentration
Determination of the maximum plasma concentration (Cmax)
Time frame: Day 1 through last follow-up (3 Days after last dose)
Characterize the PK Profile of AN2-502998: Time to Maximum Plasma Concentration
Determination the time to maximum plasma concentration (Tmax)
Time frame: Day 1 through 3 days after last dose
Characterize the PK Profile of AN2-502998: Terminal Half-Life
Determine the apparent terminal half-life (t½)
Time frame: Day 1 through 3 days after last dose
Characterize the PK Profile of AN2-502998: Area Under Plasma Concentration Curve
Area under plasma concentration-time curve from zero to a designated dosing interval
Time frame: Day 1 through 3 days after last dose
Characterize the PK Profile of AN2-502998: Apparent Plasma Clearance
Apparent plasma clearance of drug after extravascular administration CL/F
Time frame: Day 1 through 3 days after last dose