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

PHASE1RECRUITING

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.

Study details:

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 administration in healthy adult participants. The study is designed in two parts:. Part A (Single Ascending Dose \[SAD\]): Approximately 40 participants will be enrolled into sequential dose cohorts.

Each cohort will receive a single dose of ZT003 or matching placebo administered subcutaneously. Dose escalation will proceed based on safety, tolerability, and pharmacokinetic data from the preceding cohorts. Part B (Multiple Ascending Dose \[MAD\]): Approximately 36 participants will be enrolled into sequential cohorts.

Each participant will receive multiple subcutaneous doses of ZT003 or placebo. Dosing frequency and duration will be based on data obtained from Part A and guided by predefined criteria. The study will evaluate safety through the monitoring of adverse events, clinical laboratory tests, vital signs, physical examinations, ECGs, and injection site assessments.

Pharmacokinetic parameters will be measured using plasma drug concentration profiles. The results from this study will inform dose selection and design for future clinical studies in patient populations.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

TREATMENT

phase

Phase

    PHASE1

trial

Study ID

NCT07184502

Intervention or treatment

DRUG: ZT003

DRUG: ZT003

DRUG: Placebo

Conditions

  • Healthy

  • Condition: Healthy

  • DRUG: ZT003 and other drugs

  • Brisbane, Queensland, Australia

  • Sponsor: Beijing QL Biopharmaceutical Co.,Ltd

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Research sites nearby

Closest Location:

Nucleus Network Brisbane

Select from list below to view details:

  • Nucleus Network Brisbane

    Brisbane, Queensland, Australia

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Who is running the clinical trial?

BQBC

Beijing QL Biopharmaceutical Co.,Ltd

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Up to 6 Single Ascending Dose (SAD) Cohorts - ZT003 with Placebo
  • Participants will receive a single subcutaneous dose of ZT003 at ascending dose levels across up to 6 cohorts in 3:1 Ratio
Drug: ZT003 - Part1 (Single ascending dose )
    EXPERIMENTAL: Up to 2 Multiple Ascending Dose (MAD) Cohorts - ZT003 with Placebo
    • Participants will receive multiple subcutaneous doses of ZT003 at ascending dose levels across up to 2 cohorts in 3:1 Ratio
    Drug: ZT003 - Part 2(Multiple ascending dose )

      What is the study measuring?

      Primary Outcome

      MeasureDescriptionTime Frame
      Incidence of Treatment-Emergent Adverse Events (TEAEs)Not SpecifiedCollected at every visit (Screening, Day -1, Day 1 pre- and post-dose, Days 2-7, and follow-ups at Days 8, 15, 22, 29, and 36).
      Incidence of Serious Adverse Events (SAEs)Not SpecifiedCollected at every visit (Screening, Day -1, Day 1 pre- and post-dose, Days 2-7, and follow-ups at Days 8, 15, 22, 29, and 36).
      Incidence of Adverse Events of Special Interest (AESIs)Not SpecifiedCollected at every visit (Screening, Day -1, Day 1 pre- and post-dose, Days 2-7, and follow-ups at Days 8, 15, 22, 29, and 36).
      Incidence of Adverse Events Leading to Study Drug Discontinuation or WithdrawalNot SpecifiedCollected at every visit (Screening, Day -1, Day 1 pre- and post-dose, Days 2-7, and follow-ups at Days 8, 15, 22, 29, and 36).
      Incidence and Severity of Injection Site Reactions (ISRs)Not SpecifiedFrom first dose (Day 1) through End of Treatment/EOT visit (Day 85)
      Change from Baseline in Systolic Blood PressureNot SpecifiedFrom Screening (Day -35) through End of Treatment (Day 85).
      Change from Baseline in Diastolic Blood PressureNot SpecifiedFrom Screening (Day -35) through End of Treatment (Day 85).
      Change from Baseline in Pulse RateNot SpecifiedFrom Screening (Day -35) through End of Treatment (Day 85).
      Change from Baseline in Body TemperatureNot SpecifiedFrom Screening (Day -35) through End of Treatment (Day 85).
      Change from Baseline in Respiratory RateNot SpecifiedFrom Screening (Day -35) through End of Treatment (Day 85).
      Change from Baseline in ECG Heart RateNot SpecifiedFrom Screening (Day -35) through End of Treatment (Day 85).
      Change from Baseline in ECG PR IntervalNot SpecifiedFrom Screening (Day -35) through End of Treatment (Day 85).
      Change from Baseline in ECG QRS DurationNot SpecifiedFrom Screening (Day -35) through End of Treatment (Day 85).
      Change from Baseline in ECG QT IntervalNot SpecifiedFrom Screening (Day -35) through End of Treatment (Day 85).
      Change from Baseline in ECG Corrected QT Interval (QTcF)Not SpecifiedFrom Screening (Day -35) through End of Treatment (Day 85).

      Secondary Outcome

      MeasureDescriptionTime Frame
      Plasma Cmax of ZT003Not SpecifiedDay 1 to 24 hours post-dose (SAD); pre-dose to 24 hours post-final dose (MAD)
      Plasma Tmax of ZT003Not SpecifiedDay 1 to 24 hours post-dose (SAD); pre-dose to 24 hours post-final dose (MAD)
      AUC from time zero to the last quantifiable concentration of ZT003Not SpecifiedSAD: Day 1 to 96 hours post-dose; MAD: Pre-dose on Days 1, 8, 15, 22, and 29 to 96 hours post-final dose (Day 29), with additional samples up to Day 78 and at End of Treatment (Day 85).
      AUC from time zero extrapolated to infinity of ZT003Not SpecifiedSAD: Day 1 to 96 hours post-dose; MAD: Pre-dose on Days 1, 8, 15, 22, and 29 to 96 hours post-final dose (Day 29), with additional samples up to Day 78 and at End of Treatment (Day 85).
      Plasma half-life (t½) of ZT003Not SpecifiedSAD: Day 1 to 96 hours post-dose; MAD: Pre-dose on Days 1, 8, 15, 22, and 29 to 96 hours post-final dose (Day 29), with additional samples up to Day 78 and at End of Treatment (Day 85).
      Apparent Clearance (CL/F) of ZT003Not SpecifiedSAD: Day 1 to 96 hours post-dose; MAD: Pre-dose on Days 1, 8, 15, 22, and 29 to 96 hours post-final dose (Day 29), with additional samples up to Day 78 and at End of Treatment (Day 85).
      Apparent Volume of Distribution (Vz/F) of ZT003Not SpecifiedSAD: Day 1 to 96 hours post-dose; MAD: Pre-dose on Days 1, 8, 15, 22, and 29 to 96 hours post-final dose (Day 29), with additional samples up to Day 78 and at End of Treatment (Day 85).
      Presence of Anti-Drug Antibodies (ADA)Not SpecifiedBaseline, Day 29, Day 57, and End of Study (Day 85)
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      References

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

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