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

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

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

Study Overview

• Status: Completed
• Conditions: Overweight or Obesity
• Intervention / Treatment: Drug: Acetaminophen; Drug: HRS-4729 injection; Drug: HRS-4729 injection placebo; Drug: HRS9531 injection; Drug: HRS9531 injection placebo

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250013
      • Jinan Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group 1	Drug: Acetaminophen; Acetaminophen; Drug: HRS-4729 injection; HRS-4729 injection
Experimental: Treatment group 3	Drug: HRS9531 injection; HRS9531 injection
Placebo Comparator: Treatment group 2	Drug: Acetaminophen; Acetaminophen; Drug: HRS-4729 injection placebo; HRS-4729 injection placebo
Placebo Comparator: Treatment group 4	Drug: HRS9531 injection placebo; HRS9531 injection placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adverse events (AEs)	Screening period up to day 43.

Secondary Outcome Measures

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2025
• Primary Completion (Actual): March 12, 2026
• Study Completion (Actual): March 12, 2026

Study Registration Dates

• First Submitted: December 31, 2024
• First Submitted That Met QC Criteria: December 31, 2024
• First Posted (Actual): January 7, 2025

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Acetaminophen
• Other Study ID Numbers: HRS-4729-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No