What is SHR-1894 studying for dermatitis?

SHR-1894 is being studied to evaluate its safety, how it moves through and affects the body, in healthy adults. The trial is led by Suzhou Suncadia Biopharmaceuticals and aims to gather initial information important for future research. Participants will help researchers understand how the drug behaves and its tolerability.

Who may be eligible for this dermatitis clinical trial?

Adults aged 18 to 45 years who are healthy and meet specific weight and body mass index criteria may be eligible. Both males and females can join if they agree to use effective contraception during the study. People with certain medical conditions or recent medication use might not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this dermatitis clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel requirements.

Actively Recruiting

Phase 1

Age: 18Years - 45Years

All Genders

Healthy Volunteers

ID07414602

Phase I Study to Assess Safety and Effects of Single Subcutaneous Doses of SHR-1894 in Healthy Adults Aged 18 to 45

Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2026-03-18

Participants Needed

Research Sites

8 weeks

Total Duration

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

Age: 18Years - 45Years

All Genders

Healthy Volunteers

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.

Research Team

Ruifang Guan

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Phase I Study to Assess Safety and Effects of Single Subcutaneous Doses of SHR-1894 in Healthy Adults Aged 18 to 45

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria