ZT003 injections given under the skin in healthy and overweight adults

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

This trial will test whether subcutaneous ZT003 injections are safe and how the body handles the drug in healthy adults and people who are overweight or obese.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 76 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Beijing QL Biopharmaceutical Co.,Ltd (Industry-sponsored)
• Locations: 1 site (Brisbane, Queensland)
• Trial ID: NCT07184502 on ClinicalTrials.gov

What this trial studies

This first-in-human, randomized, double-blind, placebo-controlled, single-center Phase 1 study tests safety, tolerability, and pharmacokinetics of subcutaneous ZT003 in healthy adults, including overweight and obese participants. The study has two parts: a single ascending dose (SAD) phase with about 40 participants in sequential dose cohorts and a multiple ascending dose (MAD) phase with about 36 participants receiving repeated doses guided by SAD results. Dose escalation will proceed based on safety, tolerability, and pharmacokinetic data from earlier cohorts, with systematic monitoring of adverse events, laboratory tests, vital signs, ECGs, and injection sites. Plasma drug concentrations will be measured to determine PK parameters and inform dose selection for future patient studies.

Who should consider this trial

Good fit: Ideal candidates are medically healthy men and women aged 18–65 with body weight between 50 and 130 kg and a BMI of 22.0–45.0 kg/m2 who meet screening labs and ECG criteria and agree to required contraception rules.

Not a fit: People with active or clinically significant medical conditions, abnormal screening labs or ECGs, outside the specified age/weight/BMI ranges, pregnant or unwilling to use contraception, or with significant thyroid abnormalities would not be eligible and are unlikely to benefit from participating.

Why it matters

Potential benefit: If ZT003 is safe and shows predictable pharmacokinetics, the results could enable later patient trials and help identify a suitable injectable dose for future therapeutic development.

How similar studies have performed: This is a first-in-human trial so there are no prior human data for ZT003, although SAD/MAD designs and subcutaneous dosing are commonly used successfully in early drug development.

Eligibility criteria

Inclusion Criteria:

1. Healthy male and female participants, aged 18 to 65 years at the time of screening.
2. Body weight \>50 kg to \<130 kg, and BMI between 22.0 and 45.0 kg/m square.
3. Medically healthy, with no clinically significant abnormalities in medical history, physical examination, vital signs, ECG, or clinical laboratory assessments, as judged by the Investigator.
4. Females of childbearing potential must use highly effective contraception and have a negative pregnancy test at screening and Day -1.
5. Male participants must agree to use acceptable contraception from screening through at least 90 days after the last dose.
6. Able to understand and comply with study procedures and provide written informed consent.
7. Thyroid function tests within normal range as specified by the testing laboratory, unless deemed not clinically significant by the PI or designee.

Exclusion Criteria:

1. History or presence of any clinically significant disease or disorder that may put the participant at risk or interfere with study assessments.
2. Positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), or HIV antibody at screening.
3. History of drug or alcohol abuse within 12 months prior to screening.
4. 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.
5. Participation in another clinical study with an investigational product within 30 days or 5 half-lives of the investigational product before dosing.
6. Any history of significant allergy or hypersensitivity to any component of the investigational medicinal product (IMP).
7. Clinically significant ECG abnormalities, including QTc \>450 ms (males) or \>470 ms (females) at screening.
8. Abnormal clinical laboratory results at screening considered clinically significant by the Investigator.
9. History of bleeding disorders or current use of anticoagulant therapy.
10. Pregnant or lactating females, or females planning to become pregnant during the study period.

Where this trial is running

Brisbane, Queensland

• Nucleus Network Brisbane — Brisbane, Queensland, Australia (Recruiting)

Study contacts

• Study coordinator: Alex Hie Lin Wong

Conditions Healthy