Actively Recruiting
A Phase I Study of Single Subcutaneous Dose of SHR-1894 in Healthy Subjects
Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2026-03-18
40
Participants Needed
1
Research Sites
37 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The Phase I clinical study aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-1894 in healthy subjects.
CONDITIONS
Official Title
A Phase I Study of Single Subcutaneous Dose of SHR-1894 in Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteers aged 18 to 45 years at consent
- Healthy males or females
- Body weight at least 50 kg for males and 45 kg for females
- Body mass index (BMI) between 19 and 26 kg/m² inclusive
- No clinically significant abnormalities in physical exams, vital signs, ECG, chest X-rays, abdominal ultrasound, and lab tests
- Use of highly effective contraception for females of childbearing potential and males with partners of childbearing age, starting at least 2 weeks before consent and continuing through follow-up
You will not qualify if you...
- History or current diagnosis of significant diseases affecting major body systems or psychiatric/metabolic disorders
- Conditions affecting drug absorption, metabolism, or excretion
- Severe infection, trauma, or major surgery within 1 month before screening or planned surgery during the study
- Known allergy to the investigational drug or history of atopy such as asthma or eczema
- Use of medications, including prescription, over-the-counter, herbal medicines, and dietary supplements, within specified washout periods before screening or planned use during the study
- Participation in other clinical trials or prior investigational drug use within specified washout periods
- Pregnancy, breastfeeding, or positive pregnancy test at screening or baseline
- Recent significant blood donation, blood loss, or transfusion within specified timeframes
- Recent vaccination within 2 weeks before screening or planned vaccination during the study
- Significant smoking history or inability to abstain from tobacco use during the study
- Excessive alcohol use or inability to abstain from alcohol during the study
- History of illicit drug use or positive drug test
- Special dietary requirements preventing compliance with the standardized diet
- Difficult venous access or inability to tolerate frequent blood sampling
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
R
Ruifang Guan
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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