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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-16

Study Completion Date

2025-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Overweight or Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment group 1

Group Type EXPERIMENTAL

HRS-4729 injection

Intervention Type DRUG

HRS-4729 injection

Acetaminophen

Intervention Type DRUG

Acetaminophen

Treatment group 2

Group Type PLACEBO_COMPARATOR

HRS-4729 injection placebo

Intervention Type DRUG

HRS-4729 injection placebo

Acetaminophen

Intervention Type DRUG

Acetaminophen

Treatment group 3

Group Type EXPERIMENTAL

HRS9531 injection

Intervention Type DRUG

HRS9531 injection

Treatment group 4

Group Type PLACEBO_COMPARATOR

HRS9531 injection placebo

Intervention Type DRUG

HRS9531 injection placebo

Interventions

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HRS-4729 injection

Intervention Type DRUG

HRS-4729 injection placebo

Intervention Type DRUG

HRS9531 injection

Intervention Type DRUG

HRS9531 injection placebo

Intervention Type DRUG

Acetaminophen

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes