SSGJ-716 first-in-human test in healthy adults and people with moderate-to-severe atopic dermatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1, two-part study evaluating SSGJ-716. Part 1 (Single Ascending Dose) enrolls healthy adults to assess safety and tolerability at increasing doses. Part 2 (Multiple Ascending Dose) enrolls participants with moderate-to-severe atopic dermatitis to examine safety and tolerability with repeated dosing. The study uses SSGJ-716 and placebo and includes rigorous eligibility screening and contraception requirements. Primary outcomes focus on safety, tolerability, and pharmacokinetics, while no exploratory efficacy endpoints are specified in the available description.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Able to understand protocol requirements and sign a written ICF.
* Male or female subjects aged 18-45 years when signing the ICF.
* Male subjects with body weight ≥ 50 kg, and female subjects with body weight ≥ 45 kg. Subjects with BMI between 18 and 28 kg/m2.
* Subjects whose test results are normal, or abnormal without clinical significance as determined by the investigator.
* Female subjects with childbearing potential and male subjects (and their female partners) must agree to take highly effective contraceptive measures.

Exclusion Criteria:

* History of severe allergy, or with a history of allergy to the study treatment or related excipients.
* With any clinically significant diseases prior to the screening visit. Subjects with positive test results for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibody, anti-human immunodeficiency virus (HIV) antibody.
* History of of significant alcohol abuse.
* History of significant drug abuse.
* Subjects who have positive result for urine nicotine test at screening. Pregnant, or nursing females.

Where it's running

• Huashan Hospital, Fudan University
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Qinghong Zhou
• Email: zhouqinghong@3sbio.com
• Phone: +86 189113015

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.