Phase 1 Study to Assess Safety, Immune Response, and Effects of Single and Multiple Oral Doses of HS-20118 in Adults Including Healthy Volunteers and Patients with Moderate to Severe Plaque Psoriasis

What this Trial Is About

Researchers are evaluating the safety, tolerability, immune response, and how the body processes HS-20118 in adults. This study has two parts Part 1 involves healthy adults receiving a single oral dose, while Part 2 involves patients with moderate to severe plaque psoriasis receiving multiple oral doses. The study is randomized, double-blind, and placebo-controlled to compare HS-20118 with a matching placebo. Part 1 includes five dose groups with 12 participants each, receiving single ascending doses of HS-20118 or placebo. Part 2 includes six dose groups with 12 participants each, receiving multiple ascending doses of HS-20118 or placebo. Both parts involve blood sampling for pharmacokinetics, immune response, and pharmacodynamics, along with safety examinations. Participants will undergo physical exams, vital sign checks, laboratory tests, ECGs, and blood sampling at specified times. Researchers will monitor adverse events, drug levels, immune reactions, and skin condition improvements using scales like PASI and IGA. The study lasts up to 71 days in the multiple dose part, with detailed safety and effectiveness evaluations throughout.

Evaluate the Safety and Pharmacokinetics/Pharmacodynamics of HS-20118