Actively Recruiting
A Randomized, Double-blind, Placebo-controlled Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous Doses of SHR-1894 in Healthy Adults
Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2026-03-18
40
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating SHR-1894, a drug administered by single subcutaneous injection, in healthy adults aged 18 to 45 years. This Phase I clinical trial aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of SHR-1894. The study compares different doses of SHR-1894 injection with a placebo injection under controlled conditions. Participants will be randomly assigned to receive either SHR-1894 injection at varying doses or a placebo injection. Both participants and researchers will be unaware of the assigned treatment to ensure unbiased results. The study includes a follow-up period lasting up to 85 days to monitor effects and drug behavior in the body. During the trial, participants will undergo physical exams, vital sign checks, ECGs, chest X-rays, abdominal ultrasounds, and laboratory tests before and after treatment. Researchers will track any adverse events, measure drug concentrations in the blood over time, and assess immune responses. The total participation time covers screening, dosing, and monitoring visits spread across nearly three months.
CONDITIONS
Brief 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...
- The subject has voluntarily provided written informed consent and agrees to follow the study protocol.
- Healthy male or female subjects aged 18 to 45 years inclusive at the time of consent.
- Body weight of 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 examination, vital signs, ECG, chest X-rays, abdominal ultrasound, and laboratory tests.
- Females of childbearing potential and males with partners of childbearing age must use highly effective contraception for at least 2 weeks before consent and throughout the study and follow-up period.
- Willingness to abstain from sexual intercourse or continue contraception during the study with no plans for conception or sperm/ova donation.
You will not qualify if you...
- History or current diagnosis of significant diseases affecting urinary, circulatory, endocrine, neurological, digestive, respiratory, hematopoietic, immune systems, or psychiatric and metabolic disorders.
- Conditions that may affect drug absorption, metabolism, or excretion.
- Severe infection, trauma, or major surgery within 1 month prior to screening or planned surgery during the study.
- Known allergy to the study drug or its components, or history of atopy such as asthma or eczema.
- Use of medications (including prescription, over-the-counter, herbal, supplements, and vitamin A derivatives except routine vitamins and occasional acetaminophen) within 2 weeks prior to screening.
- Participation in other clinical trials or use of investigational drugs within 3 months prior to screening.
- Pregnancy, breastfeeding, or positive pregnancy test at screening or baseline.
- Significant blood donation or loss, or blood transfusion within specified timeframes before screening.
- Recent vaccination within 2 weeks prior to screening or planned vaccination during the study.
- Significant smoking history or inability to abstain from tobacco during the study.
- Excessive alcohol use or inability to abstain from alcohol during the study.
- History of illicit drug use or positive drug test at baseline.
- Special dietary requirements preventing compliance with study 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks
Participants receive a single subcutaneous injection of SHR-1894 or placebo and are monitored for safety and drug levels.
Multiple visits for assessments up to Day 85
Trial Site Locations
Total: 1 location
1
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
R
Ruifang Guan
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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