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A Phase I Study of SSGJ-716 in Healthy Adults and Participants With Moderate-to-Severe Atopic Dermatitis
Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
96
Start Date
2026-05-18
Completion Date
2028-01-29
Last Updated
2026-07-09
Healthy Volunteers
Yes
Conditions
Interventions
SSGJ-716
Single and multiple subcutaneous injection
Placebo
Single and multiple subcutaneous injection
Locations (1)
Huashan Hospital, Fudan University
Shanghai, China