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Recruiting NCT06934408

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-5817 Injection

Phase I Interventional Obesity Overweight

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HRS-5817 Injection, HRS-5817 Injection Placebo.
Who it may be relevant to
Registry conditions: Obesity, Overweight. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Injections of HRS-5817 Injection in Healthy Adult Volunteers With or Without Obesity

Overview

The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-5817 when administered subcutaneously (SC) as single and multiple doses in adults who are affected by obesity.

Interventions

  • Drug HRS-5817 Injection
    HRS-5817 injection administered subcutaneously (SC).
  • Drug HRS-5817 Injection Placebo
    HRS-5817 injection placebo administered subcutaneously (SC).

Primary outcome measures

  • Adverse events (AEs) [Time frame: Baseline up to Day 253.]
Secondary outcome measures (7)
  • Area Under the curve from time 0 to time t (AUC0-t) [Time frame: 0 to anticipated 253 days.]
  • Area Under the curve from time 0 to infinity (AUC0-∞) [Time frame: 0 to anticipated 253 days.]
  • Maximum concentration (Cmax) [Time frame: 0 to anticipated 253 days.]
  • Time to reach maximum concentration (Tmax) [Time frame: 0 to anticipated 253 days.]
  • Half-life (t1/2) [Time frame: 0 to anticipated 253 days.]
  • Apparent clearance (CL/F) [Time frame: 0 to anticipated 253 days.]
  • Proportion of anti-drug antibodies (ADA) positive subjects [Time frame: 0 to anticipated 253 days.]

Eligibility criteria

Inclusion criteria

  • Voluntarily sign the informed consent form prior to any study-related activities, understand the procedures and methods of the study, and agree to complete this study in strict accordance with the clinical study protocol.
  • Males or females aged 18-55 years old (inclusive).
  • Subjects who are generally healthy as judged by the investigator based on medical history, vital signs, physical examination, laboratory tests and electrocardiogram (ECG) results.
  • Body weight change (difference between the maximum body weight and the minimum body weight within 3 months) of no more than 5 kg within the past 3 months.
  • Female subjects of childbearing potential must agree to take highly effective contraceptive measures and avoid egg donation from the signing of the informed consent form to 6 months after the last dose, and must have a negative blood pregnancy test result before administration and not be breastfeeding. Male subjects whose partners are women of childbearing potential must agree to take highly effective contraceptive measures and avoid sperm donation from the signing of the informed consent form to 6 months after the last dose.

Exclusion criteria

  • Known or suspected allergy to any ingredient in the investigational medicinal products or related products; or history of multiple and/or severe allergies to drugs or food, or history of severe anaphylaxis.
  • History of or suffering from major diseases of cardiovascular, endocrine (except primary obesity), mental, neurological, digestive, respiratory, blood, immune or genitourinary systems, which are not suitable for participation in this study as judged by the investigator.
  • Subjects who have had severe trauma or undergone major surgical procedures within 6 months before screening, or who plan to undergo surgery during the study.
  • Subjects who have participated in and used any other clinical trial drugs or medical device treatments within 3 months prior to screening or plan to do so during the study period, or within 5 half-lives of the investigational drug before screening (whichever is longer).
  • Significant changes in diet and exercise habits within 1 month before screening, or failure to maintain a basically stable lifestyle such as diet and exercise during the study.
  • Known or suspected history of drug abuse or substance abuse, or positive urine drug screening during the screening period.
  • Other situations that may interfere with the evaluation of the study results or are not suitable for participating in this study as judged by the investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • The Second Hospital of Anhui Medical Uniersity — Hefei

Identifiers

NCT: NCT06934408 · HRS-5817-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗