NCT07184502

Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ZT003 Injection Following Single and Multiple Subcutaneous Administration in Healthy Volunteers/Overweight or Obese Volunteers

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: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: Beijing QL Biopharmaceutical Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ZT003	ZT003 is administered as a single subcutaneous injection at different dose levels.
DRUG	ZT003	ZT003 administered as multiple subcutaneous injections at different dose levels.
DRUG	Placebo	Matching placebo administered subcutaneously.

Timeline

• Start date: 2025-10-16
• Primary completion: 2026-06-06
• Completion: 2026-10-10
• First posted: 2025-09-22
• Last updated: 2026-01-30

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study