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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 SAD | Experimental |
| |
| Part 2 MAD | Experimental |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HC002 SAD | Drug | Part 1 will enroll 32 participants across 4 cohorts. Route of administration: Oral Dose interval and frequency: Single oral dose range across 4 cohorts. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety of HC002 by the incidence of adverse events | 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 | 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 | SAD- Screening to Day 4 post first dose administration; MAD- screening to Day 11 post first dose administration |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma PK parameters- Maximum plasma concentration (Cmax) after first dose of HC002 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMAX Clinical Research Pty Ltd | Adelaide | South Australia | 5000 | Australia |
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| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| HC002 MAD | Drug | Part 2 will enroll 24 participants across 3 cohorts. Route of administration: Oral Dose interval and frequency: Once daily for 7 days |
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| Placebo | Drug | Matching placebo will be administered across SAD and MAD |
|
| 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 | 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 | 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- terminal half-life (t1/2) after first dose of HC002 | 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 | 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 | 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 | 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 | 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 |