Actively Recruiting
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ZT003 Injection Following Single and Multiple Subcutaneous Administration in Healthy Volunteers/Overweight or Obese Volunteers
Led by Beijing QL Biopharmaceutical Co.,Ltd · Updated on 2026-01-30
76
Participants Needed
1
Research Sites
51 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy males and females aged 18 to 65 years at screening
- Body weight greater than 50 kg and less than 130 kg
- Body mass index between 22.0 and 45.0 kg/m²
- Medically healthy with no significant abnormalities in medical history, physical exam, vital signs, ECG, or lab tests
- Females of childbearing potential must use highly effective contraception and have negative pregnancy tests at screening and Day -1
- Male participants must agree to use acceptable contraception from screening through 90 days after last dose
- Able to understand and comply with study procedures and provide written informed consent
- Thyroid function tests within normal range or not clinically significant as judged by investigator
You will not qualify if you...
- History or presence of any significant disease or disorder that may risk participant or affect study assessments
- Positive test for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody at screening
- History of drug or alcohol abuse within 12 months before screening
- Use of prescription or over-the-counter drugs, herbal products, or supplements within 14 days before first dose unless approved by investigator
- Participation in another clinical study with an investigational product within 30 days or 5 half-lives before dosing
- History of significant allergy or hypersensitivity to any component of the investigational product
- Clinically significant ECG abnormalities including QTc >450 ms (males) or >470 ms (females) at screening
- Clinically significant abnormal lab results at screening
- History of bleeding disorders or current use of anticoagulant therapy
- Pregnant or breastfeeding females, or planning pregnancy during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Nucleus Network Brisbane
Brisbane, Queensland, Australia
Actively Recruiting
Research Team
A
Alex Hie Lin Wong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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