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

Not Applicable

Active, not recruiting

• Conditions: Moderate to Severe Plaque Psoriasis
• Interventions: Drug: SHR-1139 Injections; Drug: SHR-1139 Injections Placebo

• Registration Number: NCT07051538
• Lead Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-26
• Status Verified: 2025-06
• Study First Submitted: 2025-06-26
• Study First Submitted QC: 2025-06-26
• Last Update Submitted: 2025-07-03
• Study First Posted: 2025-07-04
• Last Update Posted: 2025-07-09
• Primary Completion: 2025-11
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

1. Subjects who fully understand the trial procedures, voluntarily agree to participate, and sign a written informed consent form.
2. Age between 18 and 55 years old (inclusive).
3. Vital signs, physical examinations, laboratory tests, and other assessments are normal or show abnormalities without clinical significance.

Exclusion Criteria

1. Subjects with any clinical disease in the circulatory, endocrine, nervous, digestive, respiratory, hematological, immunological, psychiatric systems, or metabolic abnormalities; or any other disease that may interfere with trial results.
2. History of malignant tumor.
3. Opportunistic infection within 6 months prior to screening.
4. Acute infection with systemic symptoms requiring systemic intravenous or oral anti-infective treatment within 4 weeks before baseline.
5. Participation in any drug or medical device clinical trial within 3 months prior to screening.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHR-1139 Injections Group	SHR-1139 Injections	-
SHR-1139 Injections Placebo Group	SHR-1139 Injections Placebo	-

Primary Outcome Measures

Name	Time	Method
Adverse events (AEs)	About 295 days for healthy subjects.
Serious adverse events (SAEs)	About 365 days for moderate-to-severe plaque psoriasis subjects.

Secondary Outcome Measures

Name	Time	Method
Serum concentration of SHR-1139	About 365 days for moderate-to-severe plaque psoriasis subjects.

Trial Locations

Locations (1)

Huashan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China