Actively Recruiting
Randomized Phase I Study Comparing Bioavailability and Safety of SHR-3167 Injection in Healthy Adults Aged 18 to 55
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2026-04-29
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase I clinical trial to compare the bioavailability and safety of different forms of SHR-3167 injection in healthy adults between 18 and 55 years old. This study aims to understand how the drug is absorbed and processed in the body, focusing on the maximum plasma concentration and overall exposure to the drug over time. Participants will receive one of three different specifications of SHR-3167 injection in a randomized, parallel, and open-label design. The study will monitor the drugs levels in the blood from Day 1 through Day 71, including measurements such as maximum concentration, area under the curve, time to reach maximum concentration, and half-life. Safety will be assessed by tracking any adverse events and immune responses during this period. During the study, participants will undergo physical exams, vital signs checks, ECGs, chest X-rays, and laboratory tests to ensure health status. Blood samples will be collected multiple times to analyze drug levels and antibodies. The study lasts about 71 days, with continuous monitoring for safety and drug behavior. Participants must comply with study procedures and provide informed consent before joining.
CONDITIONS
Brief 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 the time of informed consent
- Healthy subjects with a body mass index (BMI) between 19.0 and 26.0 kg/m²
- Weight of men at least 50 kg and women at least 45 kg
- No significant abnormalities in physical exams, vital signs, ECG, chest X-rays, and lab tests, or minor abnormalities without clinical significance
- For females of childbearing potential or males with partners of childbearing potential, no plans for conception or sperm/egg donation during the study and use of effective contraception
- Fasting blood glucose between 3.9 and 6.1 mmol/L and HbA1c no more than 6.0%
- Ability to understand and comply with study procedures and sign informed consent
You will not qualify if you...
- History of frequent allergies or allergic diseases or potential allergy to the study drug or its components
- Previous diseases affecting respiratory, circulatory, digestive, urinary, mental, nervous, blood, endocrine, immune systems or malignant tumors deemed unsuitable by the investigator
- Severe infections, injuries, or surgeries within the past 12 weeks or planned surgery during the trial
- Participation in other clinical trials or exposure to investigational drugs within the last 3 months
- Use of any medications, including supplements, within 2 weeks prior to randomization
- Positive tests for hepatitis B, HIV, syphilis, or hepatitis C or judged latent/active infections
- Blood donation, severe blood loss, or blood transfusion within the past 12 weeks
- Receipt of live vaccines within 1 month prior or planned during the trial
- History of drug use or positive drug tests at baseline
- Difficulty with blood collection or expected poor compliance
- Incomplete civil capacity without a valid guardian
- Any physical or psychological condition increasing trial risk or preventing completion as judged by researchers
Research Team
Y
Yanli Dong
W
Weijie Kong
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