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

Fujian Shengdi Pharmaceutical

Status and phase: Enrolling; Phase 1

Conditions: Overweight or Obesity

Treatments: Drug: HRS9531 injection; Drug: HRS-4729 injection; Drug: HRS9531 injection placebo; Drug: Acetaminophen; Drug: HRS-4729 injection placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06762600

HRS-4729-101

Details and patient eligibility

About

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

Enrollment: 103 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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103 participants in 4 patient groups, including a placebo group

Treatment group 1

Experimental group

Treatment:

Drug: Acetaminophen

Drug: HRS-4729 injection

Treatment group 2

Placebo Comparator group

Treatment:

Drug: Acetaminophen

Drug: HRS-4729 injection placebo

Treatment group 3

Experimental group

Treatment:

Drug: HRS9531 injection

Treatment group 4

Placebo Comparator group

Treatment:

Drug: HRS9531 injection placebo