Actively Recruiting

Phase 1
Age: 18Years - 55Years
All Genders
Healthy Volunteers
NCT07280936

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

Led by Beijing Suncadia Pharmaceuticals Co., Ltd · Updated on 2026-05-14

124

Participants Needed

1

Research Sites

47 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 55Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntarily sign informed consent and agree to follow the study procedures
  • Male or female aged 18 to 55 years
  • Generally healthy based on medical history, vital signs, physical exam, lab tests, and ECG
  • BMI between 19.0 and 23.9 kg/m2 for Part I or between 28.0 and 35.0 kg/m2 for Part II
Not Eligible

You will not qualify if you...

  • ECG showing QTcF >450 ms in males or >470 ms in females or other clinically significant abnormalities
  • Endocrine diseases or history affecting body weight (e.g., Cushing's syndrome, diabetes, thyroid disorders)
  • History or family history of medullary thyroid carcinoma, multiple endocrine adenomatosis type 2, pancreatitis, or symptomatic gallbladder disease
  • Significant clinical conditions in the past 12 months affecting gastrointestinal, kidney, liver, nervous, blood, endocrine, tumor, lung, immune, mental, cardiovascular, or cerebrovascular systems
  • Use of prescription, OTC drugs, supplements, vitamins (except conventional), or Chinese herbal medicines within 2 weeks prior to screening
  • Prior gastrointestinal surgery causing malabsorption or recent use of drugs affecting gastrointestinal peristalsis or weight-reducing drugs within 3 months
  • History of drug abuse in past 5 years or drug use in past 3 months; positive urine drug screen
  • Blood donation ≥200 mL within 1 month or ≥400 mL blood loss/donation within 3 months prior to screening
  • Inability to tolerate blood draws or fainting at sight of needles or blood
  • Special dietary requirements making uniform diet compliance impossible
  • Any other factors deemed unsuitable by researchers for trial participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China, 310006

Actively Recruiting

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Research Team

Z

Zi Ye

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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