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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Overweight
• Intervention / Treatment: Drug: HRS-5817 Injection; Drug: HRS-5817 Injection Placebo

• Study Type: Interventional
• Enrollment (Estimated): 92
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Sheng Feng; Phone Number: +86-0518-81220121; Email: sheng.feng@hengrui.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230601
      • Recruiting
      • The Second Hospital of Anhui Medical Uniersity
      • Principal Investigator: Wei Hu
      • Contact: Wei Hu; Phone Number: +86-13856086475; Email: hwgcp@ayefy.com
      • Contact: Yijun Du; Phone Number: +86-13866700016; Email: 2460679232@qq.com
      • Principal Investigator: Yijun Du

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. 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.
2. Males or females aged 18-55 years old (inclusive).
3. Subjects who are generally healthy as judged by the investigator based on medical history, vital signs, physical examination, laboratory tests and electrocardiogram (ECG) results.
4. 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.
5. 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:

1. 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.
2. 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.
3. 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.
4. 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).
5. 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.
6. Known or suspected history of drug abuse or substance abuse, or positive urine drug screening during the screening period.
7. 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HRS-5817 Injection Group	Drug: HRS-5817 Injection; HRS-5817 injection administered subcutaneously (SC).
Placebo Comparator: HRS-5817 Injection Placebo Group	Drug: HRS-5817 Injection Placebo; HRS-5817 injection placebo administered subcutaneously (SC).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adverse events (AEs)	Baseline up to Day 253.

Secondary Outcome Measures

Outcome Measure	Time Frame
Area Under the curve from time 0 to time t (AUC0-t)	0 to anticipated 253 days.
Area Under the curve from time 0 to infinity (AUC0-∞)	0 to anticipated 253 days.
Maximum concentration (Cmax)	0 to anticipated 253 days.
Time to reach maximum concentration (Tmax)	0 to anticipated 253 days.
Half-life (t1/2)	0 to anticipated 253 days.
Apparent clearance (CL/F)	0 to anticipated 253 days.
Proportion of anti-drug antibodies (ADA) positive subjects	0 to anticipated 253 days.

Collaborators and Investigators

• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: April 11, 2025
• First Submitted That Met QC Criteria: April 11, 2025
• First Posted (Actual): April 18, 2025

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: October 1, 2025

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
• Other Study ID Numbers: HRS-5817-101

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