NCT07051538

A Phase I Clinical Trial of Single Subcutaneous Injection or Intravenous Infusion of SHR-1139 Injection in Healthy Chinese Subjects and Multiple Subcutaneous Injections in Patients With Moderate-to-severe Plaque Psoriasis

A Randomized, Double-Blind, Dose-Escalating, Placebo-controlled Phase I Clinical Trial on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Subcutaneous Injection or Intravenous Infusion of SHR-1139 Injection in Healthy Chinese Subjects and Multiple Subcutaneous Injections in Patients With Moderate-to-severe Plaque Psoriasis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamic and immunogenicity of SHR-1139 injection in healthy subjects who receive a single subcutaneous injection or intravenous infusion of SHR-1139 injection, and in patients with moderate - to - severe plaque psoriasis who receive multiple subcutaneous injections of SHR-1139 injection.

Conditions

• Moderate to Severe Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	SHR-1139 Injections	SHR-1139 injections.
DRUG	SHR-1139 Injections Placebo	SHR-1139 injections placebo

Timeline

• Start date: 2024-06-26
• Primary completion: 2025-11-28
• Completion: 2025-11-28
• First posted: 2025-07-04
• Last updated: 2026-01-28

Locations

1 site across 1 country: China