A Study of SHR-2906 Injection in Healthy Subjects With a Single Dose and in Obese Patients With Multiple Doses

A Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase I Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-2906 Injection in Healthy Subjects With a Single Dose and in Obese Patients With Multiple Doses

This study is a randomized, double-blind, placebo-controlled, dose-escalation phase I clinical trial. This study consists of two parts: the single-dose escalation study (SAD) in healthy subjects and the multiple-dose escalation study (MAD) in obese patients.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Overweight
• Intervention / Treatment: Drug: SHR-2906 Injection; Drug: SHR-2906 Injection Placebo

• Study Type: Interventional
• Enrollment (Estimated): 124
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Zi Ye; Phone Number: +86-0518-81220121; Email: zi.ye@hengrui.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • Recruiting
      • Hangzhou First People's Hospital
      • Principal Investigator: Ying Wang
      • Contact: Ying Wang; Phone Number: +86-0571-56007501; Email: nancywangying@163.com

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 (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);
4. At screening, 19.0 ≤ BMI ≤ 23.9 kg/m2 (inclusive) for Part I or 28.0 ≤ BMI ≤ 35.0 kg/m2 (inclusive) for Part II.

Exclusion Criteria:

1. During screening, electrocardiogram (ECG) indicated that QTcF>450 ms in males and QTcF> 470 ms in females, as well as other abnormal ECG and vital signs that were judged by the researchers to have clinical significance;
2. There are endocrine diseases or medical histories that may significantly affect body weight during screening (such as Cushing's syndrome, diabetes, hypothyroidism or hyperthyroidism, etc.);
3. There is a history or family history of medullary thyroid carcinoma, multiple endocrine adenomatosis type 2, or a history of pancreatitis or symptomatic gallbladder disease;
4. Other clinical findings within 12 months prior to screening that show clinical significance in the following diseases (including but not limited to gastrointestinal, kidney, liver, nervous, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases);
5. Use of prescription drugs (excluding topical eye/nasal drops and creams without systemic exposure risk), over-the-counter drugs, food supplements, vitamins and Chinese herbal medicines (excluding conventional vitamins) within two weeks prior to screening;
6. Having undergone gastrointestinal surgery that may cause malabsorption before screening, or having taken drugs that directly affect gastrointestinal peristalsis for a long time. For example: having undergone bariatric surgery or procedures (such as gastric banding), or having used weight-reducing drugs (including but not limited to orlistat) within 3 months before administration, or having a weight change of more than 10% within 3 months before administration;
7. Those who have a history of drug abuse in the past five years or have used drugs in the three months prior to the trial; Or the urine drug screening is positive;
8. Blood donation of ≥200 mL within one month prior to screening; Or those who have donated ≥400 mL of blood or lost ≥400 mL of blood within 3 months prior to screening due to trauma or major surgical operations;
9. Inability to tolerate venipuncture for blood collection or fainting at the sight of needles and blood;
10. There are special dietary requirements and they cannot follow the uniform diet;
11. Subjects who the researchers consider to have other factors that make them unsuitable for participating in this trial.

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: SHR-2906 Injection Group	Drug: SHR-2906 Injection; SHR-2906 injection, in different doses.
Placebo Comparator: SHR-2906 Injection Placebo Group	Drug: SHR-2906 Injection Placebo; SHR-2906 injection placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events (AEs).	Part1: 57 days; Part2: 113 days.
Incidence of serious adverse events (SAEs).	Part1: 57 days; Part2: 113 days.

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum concentration (Cmax).	Part1: 57 days; Part2: 113 days.
Time of maximum concentration (Tmax).	Part1: 57 days; Part2: 113 days.
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last).	Part1: 57 days; Part2: 113 days.
Area under the concentration-time curve from time zero to infinity (AUC0-inf).	Part1: 57 days; Part2: 113 days.
Area under the concentration-time curve from time zero to the end of the dosing interval tau (AUC0-tau).	Part1: 57 days; Part2: 113 days.
Elimination half-life (t1/2).	Part1: 57 days; Part2: 113 days.
Apparent clearance (CL/F).	Part1: 57 days; Part2: 113 days.
Apparent volume of distribution (Vz/F).	Part1: 57 days; Part2: 113 days.

Collaborators and Investigators

• Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 1, 2025
• First Submitted That Met QC Criteria: December 1, 2025
• First Posted (Actual): December 15, 2025

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

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: SHR-2906-101

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