Status:
NOT_YET_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
Lead Sponsor:
Beijing QL Biopharmaceutical Co.,Ltd
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 ...
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 administ...
Eligibility Criteria
Inclusion
- Healthy male and female participants, aged 18 to 65 years at the time of screening.
- Body weight \>50 kg to \<130 kg, and BMI between 22.0 and 45.0 kg/m square.
- Medically healthy, with no clinically significant abnormalities in medical history, physical examination, vital signs, ECG, or clinical laboratory assessments, as judged by the Investigator.
- Females of childbearing potential must use highly effective contraception and have a negative pregnancy test at screening and Day -1.
- Male participants must agree to use acceptable contraception from screening through at least 90 days after the last dose.
- Able to understand and comply with study procedures and provide written informed consent.
- Thyroid function tests within normal range as specified by the testing laboratory, unless deemed not clinically significant by the PI or designee.
Exclusion
- History or presence of any clinically significant disease or disorder that may put the participant at risk or interfere with study assessments.
- Positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), or HIV antibody at screening.
- History of drug or alcohol abuse within 12 months prior to screening.
- Use of prescription drugs, over-the-counter medications, herbal products, or supplements within 14 days (or 5 half-lives) prior to first dose unless deemed acceptable by the Investigator.
- Participation in another clinical study with an investigational product within 30 days or 5 half-lives of the investigational product before dosing.
- Any history of significant allergy or hypersensitivity to any component of the investigational medicinal product (IMP).
- Clinically significant ECG abnormalities, including QTc \>450 ms (males) or \>470 ms (females) at screening.
- Abnormal clinical laboratory results at screening considered clinically significant by the Investigator.
- History of bleeding disorders or current use of anticoagulant therapy.
- Pregnant or lactating females, or females planning to become pregnant during the study period.
Key Trial Info
Start Date :
October 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 10 2026
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT07184502
Start Date
October 9 2025
End Date
October 10 2026
Last Update
September 22 2025
Active Locations (1)
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1
Nucleus Network Brisbane
Brisbane, Queensland, Australia