Actively Recruiting
A Clinical Study Comparing the Relative Bioavailability and Safety of SHR-3167 Injection
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2026-04-29
60
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a randomized, parallel, open-label Phase I clinical trial aimed at comparing the bioavailability and safety of different specifications of SHR-3167 injection, with healthy subjects as the research subjects.
CONDITIONS
Official Title
A Clinical Study Comparing the Relative Bioavailability and Safety of SHR-3167 Injection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 55 years at consent signing
- Healthy with body mass index (BMI) between 19.0 and 26.0 kg/m²
- Men must weigh at least 50 kg and women at least 45 kg
- No significant abnormalities in physical exam, vital signs, ECG, chest X-ray, or lab tests
- Fasting blood glucose between 3.9 and 6.1 mmol/L
- Glycated hemoglobin (HbA1c) no more than 6.0%
- Ability and willingness to comply with study procedures and sign informed consent
- Female participants of childbearing potential and male participants with partners of childbearing potential must use effective contraception and avoid unprotected sex as specified
- Negative pregnancy test for women of childbearing potential and not breastfeeding
You will not qualify if you...
- History of frequent allergies or allergic diseases or potential allergy to study drug or components
- History of significant diseases affecting respiratory, circulatory, digestive, urinary, mental, nervous, blood, endocrine, immune systems, or cancer
- Severe infections, injuries, or surgeries within past 12 weeks or planned surgery during study
- Participation in other clinical trials or use of trial drugs within past 3 months or within 5 half-lives of drug
- Use of any medication including prescription, over-the-counter, herbal, or supplements within 2 weeks before randomization
- Positive tests for hepatitis B, HIV, syphilis, or hepatitis C, or latent/active infections
- Blood donation or severe blood loss (≥400 mL) or blood transfusion within past 12 weeks
- Receipt of live vaccines within 1 month prior or planned during study
- History of drug use or substance abuse or positive drug test at baseline
- Difficulty with blood collection or expected non-compliance
- Incomplete civil capacity without a valid guardian
- Any physical or psychological condition increasing trial risk or affecting compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Xiangya Hospital, Central South University
Changsha, Hunan, China, 410008
Actively Recruiting
Research Team
Y
Yanli Dong
CONTACT
W
Weijie Kong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here