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

Phase 1

Recruiting

• Conditions: Overweight or Obesity
• Interventions: Drug: HRS-4729 injection; Drug: HRS-4729 injection placebo; Drug: HRS9531 injection; Drug: HRS9531 injection placebo; Drug: Acetaminophen

• Registration Number: NCT06762600
• Lead Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-31
• Study First Submitted QC: 2024-12-31
• Study First Posted: 2025-01-07
• Study Start: 2025-01-16
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-04-30
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

1. 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.
2. Male or female subjects; aged 18 to 55 years.
3. 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

1. 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.
2. A history of significant gastrointestinal disease or related symptoms, conditions affecting gastric emptying, or prior gastrointestinal surgery.
3. 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.
4. Participation in any drug or medical device clinical trial within 3 months prior to screening.
5. 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.
6. Clinically significant abnormalities on 12-lead ECG as determined by the investigator.
7. Known or suspected history of drug abuse or substance dependence, or positive urine drug screen during the screening period.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group 1	HRS-4729 injection	-
Treatment group 1	Acetaminophen	-
Treatment group 2	HRS-4729 injection placebo	-
Treatment group 2	Acetaminophen	-
Treatment group 3	HRS9531 injection	-
Treatment group 4	HRS9531 injection placebo	-

Primary Outcome Measures

Name	Time	Method
Adverse events (AEs)	Screening period up to day 43.

Secondary Outcome Measures

Name	Time	Method
The maximum plasma concentration (Cmax)	Post-dose at day 1 to day 43.
Time to maximum plasma concentration (Tmax)	Post-dose at day 1 to day 43.
Terminal half-life (t1/2)	Post-dose at day 1 to day 43.
Apparent clearance (CL/F)	Post-dose at day 1 to day 43.
Apparent volume of distribution (Vz/F)	Post-dose at day 1 to day 43.
Anti-HRS-4729 antibodies	Post-dose at day 1 to day 43.
Changes from baseline in Fasting Body Weight	Run-in Period up to Day 113.
Changes from baseline in Fasting Plasma Glucose	Run-in Period up to Day 113.
Changes from baseline in Fasting Insulin	Run-in Period up to Day 113.
Changes from baseline in Fasting C-Peptide	Run-in Period up to Day 113.
Total fat mass	Run-in Period up to Day 113.

Trial Locations

Locations (1)

Jinan Central Hospital; 🇨🇳 Jinan, Shandong, China