Phase 1 Safety and Effect Study of SSGJ-716 Injection in Healthy Adults and Adults With Moderate-to-Severe Atopic Dermatitis Aged 18 to 45

What this Trial Is About

Researchers are conducting a Phase 1 study to evaluate the safety and tolerability of an investigational drug called SSGJ-716. This study involves both healthy adults and adults with moderate-to-severe atopic dermatitis AD, aiming to understand how the drug affects these two groups. The study is designed as a randomized, double-blind trial with a primary focus on treatment outcomes. The study includes two parts the first part involves single ascending doses SAD given to healthy adults, while the second part involves multiple ascending doses MAD administered to adults with moderate-to-severe AD. Both SSGJ-716 and placebo are given as single or multiple subcutaneous injections. Participants receive these injections under controlled conditions during the trial. Participants will be monitored closely for adverse events and serious adverse events over an 85-day period. Blood samples will be taken to measure drug concentration and immune response markers. Safety assessments and laboratory tests will be conducted to track tolerability. The total participation duration may extend up to nearly two years, with scheduled visits and evaluations following the dosing periods.

A Phase I Study of SSGJ-716 in Healthy Adults and Participants With Moderate-to-Severe Atopic Dermatitis