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NCT Number: NCT07280936

A Study 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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 310006, China

Location status: Recruiting

Location contact

Ying Wang

CONTACT

[email protected]

+86-0571-56007501

Ying Wang

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 (inclusive);
  • Subjects who are generally healthy as judged by the investigator based on medical history, vital signs, physical examination, laboratory tests, and electrocardiogram (ECG);
  • 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

  • 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;
  • 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.);
  • 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;
  • 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);
  • 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;
  • 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;
  • 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;
  • 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;
  • Inability to tolerate venipuncture for blood collection or fainting at the sight of needles and blood;
  • There are special dietary requirements and they cannot follow the uniform diet;
  • Subjects who the researchers consider to have other factors that make them unsuitable for participating in this trial.

Treatment and study plan

SHR-2906 Injection

Drug

SHR-2906 injection, in different doses.

SHR-2906 Injection Placebo

Drug

SHR-2906 injection placebo.

Primary outcomes

  1. Incidence of adverse events (AEs).

    Time frame: Part1: 57 days; Part2: 113 days.

  2. Incidence of serious adverse events (SAEs).

    Time frame: Part1: 57 days; Part2: 113 days.

Secondary outcomes

  1. Maximum concentration (Cmax).

    Time frame: Part1: 57 days; Part2: 113 days.

  2. Time of maximum concentration (Tmax).

    Time frame: Part1: 57 days; Part2: 113 days.

  3. Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last).

    Time frame: Part1: 57 days; Part2: 113 days.

  4. Area under the concentration-time curve from time zero to infinity (AUC0-inf).

    Time frame: Part1: 57 days; Part2: 113 days.

  5. Area under the concentration-time curve from time zero to the end of the dosing interval tau (AUC0-tau).

    Time frame: Part1: 57 days; Part2: 113 days.

  6. Elimination half-life (t1/2).

    Time frame: Part1: 57 days; Part2: 113 days.

  7. Apparent clearance (CL/F).

    Time frame: Part1: 57 days; Part2: 113 days.

  8. Apparent volume of distribution (Vz/F).

    Time frame: Part1: 57 days; Part2: 113 days.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Beijing Suncadia Pharmaceuticals Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 15, 2025
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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