Evaluating the safety and effects of HRS-4729 injection in healthy individuals

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

This study is testing a new injection called HRS-4729 in healthy people to see if it's safe and how it works, which could help with future treatments for overweight or obesity.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 103 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT06762600 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of HRS-4729 injection in healthy subjects. Participants will receive either the HRS-4729 injection or a placebo, along with other injections for comparison. The study will involve monitoring participants for any adverse effects and measuring how the drug is processed in the body. The goal is to gather data that could inform future treatments for overweight or obesity.

Who should consider this trial

Good fit: Ideal candidates are healthy males and females aged 18 to 55 who have stable body weight.

Not a fit: Patients with significant underlying health conditions or recent major surgeries may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new treatment options for overweight or obesity.

How similar studies have performed: While this approach is being evaluated in this specific context, similar studies have shown promise in assessing new treatments for obesity.

Eligibility criteria

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.

Where this trial is running

Jinan, Shandong

• Jinan Central Hospital — Jinan, Shandong, China (Recruiting)

Study contacts

• Study coordinator: Pingan Yao

Conditions Overweight or Obesity