Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ZT003 Injection Following Single and Multiple Subcutaneous Administration in Healthy Volunteers/Overweight or Obese Volunteers
NCT07184502 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 76
Last updated 2026-01-30
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.
Conditions
- Healthy
Interventions
- 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
-
Matching placebo administered subcutaneously.
Sponsors & Collaborators
-
Beijing QL Biopharmaceutical Co.,Ltd
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-10-16
- Primary Completion
- 2026-06-06
- Completion
- 2026-10-10
- FDA Drug
- Yes
Countries
- Australia
Study Locations
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