A Phase I Study of SSGJ-716 in Healthy Adults and Participants With Moderate-to-Severe Atopic Dermatitis
Recruiting now · Phase 1 · Has a placebo group
Conditions studied: AD
In brief
The purpose of this Phase 1 study is to evaluate the safety and tolerability of a new investigational drug called SSGJ-716 in healthy adults and in participants with moderate-to-severe atopic dermatitis (AD). The study has two parts. The first part (Single Ascending Dose, SAD) will enroll healthy adults.The second part (Multiple Ascending Dose, MAD) will enroll participants with moderate-to-severe AD.
Key facts
- Study ID
- NCT07693738
- Run by
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
- People needed
- 96
- Starts
- 2026-05-18
- Expected to finish
- 2028-01-29
- Last updated by the study team
- 2026-07-10
Who can join
Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- Huashan Hospital, Fudan University — Shanghai, China (enrolling)
Full record on ClinicalTrials.gov
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