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

ConditionHealthy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBeijing QL Biopharmaceutical Co.,Ltd

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • ZT003
  • ZT003
  • Placebo

Treatment groups

76 Participants
are divided into 3 treatment groups