NCT07693738RecruitingPhase 1
A Phase I Study of SSGJ-716 in Healthy Adults and Participants With Moderate-to-Severe Atopic Dermatitis
A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Characteristics of SSGJ-716 Injection Administered Subcutaneously in Healthy Chinese Adults and Participants With Moderate-to-Severe Atopic Dermatitis
Source: ClinicalTrials.gov · Last updated 10 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 96 (estimated)
- First submitted
- 24 Apr 2026
- Start date
- 18 May 2026
- Primary completion date
- 29 Aug 2027
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT07693738
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 96
- From 18 May 2026 to the primary completion date, 29 Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- History of severe allergy, or with a history of allergy to the study treatment or related excipients.
- History of of significant alcohol abuse.
- History of significant drug abuse.
Other
- Subjects who have positive result for urine nicotine test at screening. Pregnant, or nursing females.
Who the study is looking for
- 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.
Age in the registry: 18 years to 45 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Huashan Hospital, Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.