Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a Phase 1, randomized, double-blind, placebo-controlled, single-center study designed to evaluate the safety, tolerability, and pharmacokinetics of ZT003 following subcutaneous administration in healthy adult participants. The study includes both single ascending dose (SAD) and multiple ascending dose (MAD) parts.
This is a first-in-human, Phase 1, randomized, single-center, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of ZT003 following subcutaneous administration in healthy adult participants. The study is designed in two parts:
Part A (Single Ascending Dose [SAD]): Approximately 40 participants will be enrolled into sequential dose cohorts. Each cohort will receive a single dose of ZT003 or matching placebo administered subcutaneously. Dose escalation will proceed based on safety, tolerability, and pharmacokinetic data from the preceding cohorts.
Part B (Multiple Ascending Dose [MAD]): Approximately 36 participants will be enrolled into sequential cohorts. Each participant will receive multiple subcutaneous doses of ZT003 or placebo. Dosing frequency and duration will be based on data obtained from Part A and guided by predefined criteria.
The study will evaluate safety through the monitoring of adverse events, clinical laboratory tests, vital signs, physical examinations, ECGs, and injection site assessments. Pharmacokinetic parameters will be measured using plasma drug concentration profiles. The results from this study will inform dose selection and design for future clinical studies in patient populations.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Up to 5 Single Ascending Dose (SAD) Cohorts - ZT003 | Experimental | Participants will receive a single subcutaneous dose of ZT003 at ascending dose levels across up to 5 cohorts. |
|
| Up to 3 Multiple Ascending Dose (MAD) Cohorts - ZT003 | Experimental | Participants will receive multiple subcutaneous doses of ZT003 at ascending dose levels across up to 3 cohorts. |
|
| SAD/MAD Placebo | Placebo Comparator | Participants will receive either a single or multiple subcutaneous doses of placebo, corresponding to the dosing schedule of the respective cohort (SAD or MAD). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZT003 | Drug | ZT003 is administered as a single subcutaneous injection at different dose levels. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events (TEAEs) | Collected at every visit (Screening, Day -1, Day 1 pre- and post-dose, Days 2-7, and follow-ups at Days 8, 15, 22, 29, and 36). | |
| Incidence of Serious Adverse Events (SAEs) | Collected at every visit (Screening, Day -1, Day 1 pre- and post-dose, Days 2-7, and follow-ups at Days 8, 15, 22, 29, and 36). | |
| Incidence of Adverse Events of Special Interest (AESIs) | Collected at every visit (Screening, Day -1, Day 1 pre- and post-dose, Days 2-7, and follow-ups at Days 8, 15, 22, 29, and 36). | |
| Incidence of Adverse Events Leading to Study Drug Discontinuation or Withdrawal | Collected at every visit (Screening, Day -1, Day 1 pre- and post-dose, Days 2-7, and follow-ups at Days 8, 15, 22, 29, and 36). | |
| Incidence and Severity of Injection Site Reactions (ISRs) | From first dose (Day 1) through End of Treatment/EOT visit (Day 85) | |
| Change from Baseline in Systolic Blood Pressure | From Screening (Day -35) through End of Treatment (Day 85). | |
| Change from Baseline in Diastolic Blood Pressure | From Screening (Day -35) through End of Treatment (Day 85). | |
| Change from Baseline in Pulse Rate | From Screening (Day -35) through End of Treatment (Day 85). | |
| Change from Baseline in Body Temperature |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Cmax of ZT003 | Day 1 to 24 hours post-dose (SAD); pre-dose to 24 hours post-final dose (MAD) | |
| Plasma Tmax of ZT003 | Day 1 to 24 hours post-dose (SAD); pre-dose to 24 hours post-final dose (MAD) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alex Hie Lin Wong | Contact | +8615068120202 | huilin@qlbiopharm.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network Brisbane | Recruiting | Brisbane | Queensland | Australia |
Not provided
Not provided
Not provided
Not provided
Not provided
| ZT003 | Drug | ZT003 administered as multiple subcutaneous injections at different dose levels. |
|
| Placebo | Drug | Matching placebo administered subcutaneously. |
|
| From Screening (Day -35) through End of Treatment (Day 85). |
| Change from Baseline in Respiratory Rate | From Screening (Day -35) through End of Treatment (Day 85). |
| Change from Baseline in ECG Heart Rate | From Screening (Day -35) through End of Treatment (Day 85). |
| Change from Baseline in ECG PR Interval | From Screening (Day -35) through End of Treatment (Day 85). |
| Change from Baseline in ECG QRS Duration | From Screening (Day -35) through End of Treatment (Day 85). |
| Change from Baseline in ECG QT Interval | From Screening (Day -35) through End of Treatment (Day 85). |
| Change from Baseline in ECG Corrected QT Interval (QTcF) | From Screening (Day -35) through End of Treatment (Day 85). |
| AUC from time zero to the last quantifiable concentration of ZT003 | SAD: Day 1 to 96 hours post-dose; MAD: Pre-dose on Days 1, 8, 15, 22, and 29 to 96 hours post-final dose (Day 29), with additional samples up to Day 78 and at End of Treatment (Day 85). |
| AUC from time zero extrapolated to infinity of ZT003 | SAD: Day 1 to 96 hours post-dose; MAD: Pre-dose on Days 1, 8, 15, 22, and 29 to 96 hours post-final dose (Day 29), with additional samples up to Day 78 and at End of Treatment (Day 85). |
| Plasma half-life (t½) of ZT003 | SAD: Day 1 to 96 hours post-dose; MAD: Pre-dose on Days 1, 8, 15, 22, and 29 to 96 hours post-final dose (Day 29), with additional samples up to Day 78 and at End of Treatment (Day 85). |
| Apparent Clearance (CL/F) of ZT003 | SAD: Day 1 to 96 hours post-dose; MAD: Pre-dose on Days 1, 8, 15, 22, and 29 to 96 hours post-final dose (Day 29), with additional samples up to Day 78 and at End of Treatment (Day 85). |
| Apparent Volume of Distribution (Vz/F) of ZT003 | SAD: Day 1 to 96 hours post-dose; MAD: Pre-dose on Days 1, 8, 15, 22, and 29 to 96 hours post-final dose (Day 29), with additional samples up to Day 78 and at End of Treatment (Day 85). |
| Presence of Anti-Drug Antibodies (ADA) | Baseline, Day 29, Day 57, and End of Study (Day 85) |