Tests SSGJ-716 in healthy adults and adults with atopic dermatitis
Tests the new drug SSGJ-716 for safety in healthy adults and adults with atopic dermatitis.
Plain-language title generated from the registry record
Registry title: A Phase I Study of SSGJ-716 in Healthy Adults and Participants With Moderate-to-Severe Atopic Dermatitis
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 45 years old?
Source: NCT07693738, who can take part
Where in China
- Huashan Hospital, Fudan UniversityShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
- Trial code
- NCT07693738
- Record updated
- 10 July 2026
- Original description
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).Read full original descriptionShow less
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
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.
Inclusion: 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: 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 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; Subjects who have positive result for urine nicotine test at screening. Pregnant, or nursing females.