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

NCT07051538 | Completed Phase 1

• 1 other identifier: SHR-1139-101
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Moderate to Severe Plaque Psoriasis

Outcome Measures

Primary Outcomes (4)

• Adverse events (AEs)

  About 365 days for moderate-to-severe plaque psoriasis subjects

• Adverse events (AEs)

  About 295 days for healthy subjects.

• Serious adverse events (SAEs)

  About 295 days for healthy subjects.

• Serious adverse events (SAEs)

  About 365 days for moderate-to-severe plaque psoriasis subjects.

Secondary Outcomes (2)

• Serum concentration of SHR-1139

  About 253 days for healthy subjects.

• Serum concentration of SHR-1139

  About 365 days for moderate-to-severe plaque psoriasis subjects.

Study Arms (2)

SHR-1139 Injections Group

EXPERIMENTAL

Drug: SHR-1139 Injections

SHR-1139 Injections Placebo Group

PLACEBO COMPARATOR

Drug: SHR-1139 Injections Placebo

Interventions

SHR-1139 Injections DRUG

SHR-1139 injections.

SHR-1139 Injections Group

SHR-1139 Injections Placebo DRUG

SHR-1139 injections placebo

SHR-1139 Injections Placebo Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• History of malignant tumor.
• Opportunistic infection within 6 months prior to screening.
• Acute infection with systemic symptoms requiring systemic intravenous or oral anti-infective treatment within 4 weeks before baseline.
• Participation in any drug or medical device clinical trial within 3 months prior to screening.

Sponsors & Collaborators

• Guangdong Hengrui Pharmaceutical Co., Ltd: lead

Study Sites (1)

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200031, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 4, 2025
• Study Start: June 26, 2024
• Primary Completion: November 28, 2025
• Study Completion: November 28, 2025
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

CN (1)