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Completed

NCT Number: NCT06762600

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-4729 Injection in Healthy Subjects

The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-4729 injection in healthy subjects.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Jinan Central Hospital

Jinan, Shandong, 250013, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Voluntarily provides written informed consent prior to the initiation of any study-related activities and demonstrates understanding of the procedures and methods involved in the study, agreeing to adhere strictly to the clinical trial protocol to complete the study.
  • Male or female subjects; aged 18 to 55 years.
  • Self-reports no more than a 5 kg change in body weight during the 3 months prior to screening (including the screening visit).

Exclusion criteria

  • A history of current significant disease in the neurological, psychiatric, cardiovascular, gastrointestinal, respiratory, genitourinary, endocrine, hematologic, or immune systems, as determined by the investigator, which would render the subject unsuitable for participation in this trial.
  • A history of significant gastrointestinal disease or related symptoms, conditions affecting gastric emptying, or prior gastrointestinal surgery.
  • Subjects who have had a major surgery or severe trauma within 6 months prior to screening, or who are planned for surgical procedures during the trial period.
  • Participation in any drug or medical device clinical trial within 3 months prior to screening.
  • Any abnormal physical examination, vital signs, laboratory tests, chest X-ray and abdominal ultrasound findings deemed clinically significant by the investigator, rendering the subject unsuitable for participation.
  • Clinically significant abnormalities on 12-lead ECG as determined by the investigator.
  • Known or suspected history of drug abuse or substance dependence, or positive urine drug screen during the screening period.

Treatment and study plan

HRS-4729 Injection

Drug

HRS-4729 injection

HRS-4729 Injection Placebo

Drug

HRS-4729 injection placebo

HRS9531 injection

Drug

HRS9531 injection

HRS9531 injection Placebo

Drug

HRS9531 injection placebo

Acetaminophen

Drug

Acetaminophen

Primary outcomes

  1. Adverse events (AEs)

    Time frame: Screening period up to day 43.

Secondary outcomes

  1. The maximum plasma concentration (Cmax)

    Time frame: Post-dose at day 1 to day 43.

  2. Time to maximum plasma concentration (Tmax)

    Time frame: Post-dose at day 1 to day 43.

  3. Terminal half-life (t1/2)

    Time frame: Post-dose at day 1 to day 43.

  4. Apparent clearance (CL/F)

    Time frame: Post-dose at day 1 to day 43.

  5. Apparent volume of distribution (Vz/F)

    Time frame: Post-dose at day 1 to day 43.

  6. Anti-HRS-4729 antibodies

    Time frame: Post-dose at day 1 to day 43.

  7. Changes from baseline in Fasting Body Weight

    Time frame: Run-in Period up to Day 113.

  8. Changes from baseline in Fasting Plasma Glucose

    Time frame: Run-in Period up to Day 113.

  9. Changes from baseline in Fasting Insulin

    Time frame: Run-in Period up to Day 113.

  10. Changes from baseline in Fasting C-Peptide

    Time frame: Run-in Period up to Day 113.

  11. Total fat mass

    Time frame: Run-in Period up to Day 113.

Sponsors and collaborators

Lead sponsor

Fujian Shengdi Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Double-Blind, Dose-Escalation, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Subcutaneous Injections of HRS-4729 Injection in Healthy Subjects

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 7, 2025
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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