This is a first-in-human (FIH) study to evaluate the safety, tolerability, and pharmacokinetics (PK) of single and multiple ascending oral doses of HC002 in healthy adult participants.
This is a single center, randomized, double-blind, placebo-controlled, two-part study to evaluate the safety, tolerability, and PK of single (Part 1) and multiple (Part 2) oral doses of HC002. The study will enroll approximately 56 participants across 2 parts. In Part 1 (SAD), there will be 4 cohorts and in Part 2 (MAD), there will be 3 cohorts. In Part 1, a single dose of HC002 or placebo will be administered on Day 1. In Part 2, multiple doses of HC002 or placebo will be administered once daily (QD) from Day 1 to Day 7.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
56
Part 1 will enroll 32 participants across 4 cohorts. Route of administration: Oral Dose interval and frequency: Single oral dose range across 4 cohorts.
Part 2 will enroll 24 participants across 3 cohorts. Route of administration: Oral Dose interval and frequency: Once daily for 7 days
Matching placebo will be administered across SAD and MAD
CMAX Clinical Research Pty Ltd
Adelaide, South Australia, Australia
To assess the safety of HC002 by the incidence of adverse events
Time frame: SAD- Screening to Day 4 post first dose administration; MAD- screening to Day 11 post first dose administration
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
Time frame: SAD- Screening to Day 4 post first dose administration; MAD- screening to Day 11 post first dose administration
Number of participants with changes to the electrocardiogram (ECG) from baseline recorded as adverse events
Time frame: SAD- Screening to Day 4 post first dose administration; MAD- screening to Day 11 post first dose administration
Plasma PK parameters- Maximum plasma concentration (Cmax) after first dose of HC002
Time frame: SAD-Samples will be collected on Day 1 to Day 3 post first dose administration; MAD-Samples collected across 11 timepoints on Day 1 and Day 7 post first dose administration
Plasma PK parameters- Time for maximum plasma concentration (Tmax) after first dose of HC002
Time frame: SAD-Samples will be collected on Day 1 to Day 3 post first dose administration; MAD-Samples collected across 11 timepoints on Day 1 and Day 7 post first dose administration
Plasma PK parameters-- Area under curve (AUC) after first dose of HC002
Time frame: SAD-Samples will be collected on Day 1 to Day 3 post first dose administration; MAD-Samples collected across 11 timepoints on Day 1 and Day 7 post first dose administration
Plasma PK parameters- Apparent clearance (CL/F) after first dose of HC002
Time frame: SAD-Samples will be collected on Day 1 to Day 3 post first dose administration; MAD-Samples collected across 11 timepoints on Day 1 and Day 7 post first dose administration
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Plasma PK parameters- terminal half-life (t1/2) after first dose of HC002
Time frame: SAD-Samples will be collected on Day 1 to Day 3 post first dose administration; MAD-Samples collected across 11 timepoints on Day 1 and Day 7 post first dose administration
Plasma PK parameters- Vz/F (apparent volume of distribution) after first dose of HC002
Time frame: SAD-Samples will be collected on Day 1 to Day 3 post first dose administration; MAD-Samples collected across 11 timepoints on Day 1 and Day 7 post first dose administration
Urine PK parameters- Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2) after first dose of HC002
Time frame: SAD-Samples will be collected 4 timepoints from Day1 to Day 2 post first dose administration; MAD- Samples collected across 5 time-intervals from Day 1 to Day 7 post first dose administration]
Urine PK parameters- fet1-t2 (fraction of analyte excreted in urine from time point t1 to t2) after first dose of HC002
Time frame: SAD-Samples will be collected 4 timepoints from Day1 to Day 2 post first dose administration; MAD- Samples collected across 5 time-intervals from Day 1 to Day 7 post first dose administration
Urine PK parameters-Clearance rate (CLr) after first dose of HC002
Time frame: SAD-Samples will be collected 4 timepoints from Day1 to Day 2 post first dose administration; MAD- Samples collected across 5 time-intervals from Day 1 to Day 7 post first dose administration