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RECRUITING
NCT07693738
PHASE1

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.

View on ClinicalTrials.gov

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

DRUG

SSGJ-716

Single and multiple subcutaneous injection

DRUG

Placebo

Single and multiple subcutaneous injection

Locations (1)

Huashan Hospital, Fudan University

Shanghai, China