Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-03-08 @ 3:14 AM
Study NCT ID:
NCT07184502
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-22
First Post:
2025-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ZT003 Injection Following Single and Multiple Subcutaneous Administration in Healthy Volunteers/Overweight or Obese Volunteers
Sponsor:
Beijing QL Biopharmaceutical Co.,Ltd
Organization:
Study Overview
Official Title:
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ZT003 Injection in Healthy Volunteers and Overweight or Obese Volunteers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: