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

January 27, 2026 updated by: Guangdong Hengrui Pharmaceutical Co., Ltd

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200031
        • Huashan Hospital, Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SHR-1139 Injections Group
Drug: SHR-1139 Injections
SHR-1139 injections.
Placebo Comparator: SHR-1139 Injections Placebo Group
Drug: SHR-1139 Injections Placebo
SHR-1139 injections placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events (AEs)
Time Frame: About 365 days for moderate-to-severe plaque psoriasis subjects
About 365 days for moderate-to-severe plaque psoriasis subjects
Adverse events (AEs)
Time Frame: About 295 days for healthy subjects.
About 295 days for healthy subjects.
Serious adverse events (SAEs)
Time Frame: About 295 days for healthy subjects.
About 295 days for healthy subjects.
Serious adverse events (SAEs)
Time Frame: About 365 days for moderate-to-severe plaque psoriasis subjects.
About 365 days for moderate-to-severe plaque psoriasis subjects.

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum concentration of SHR-1139
Time Frame: About 253 days for healthy subjects.
About 253 days for healthy subjects.
Serum concentration of SHR-1139
Time Frame: About 365 days for moderate-to-severe plaque psoriasis subjects.
About 365 days for moderate-to-severe plaque psoriasis subjects.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Hengrui Pharmaceutical Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2024

Primary Completion (Actual)

November 28, 2025

Study Completion (Actual)

November 28, 2025

Study Registration Dates

First Submitted

June 26, 2025

First Submitted That Met QC Criteria

June 26, 2025

First Posted (Actual)

July 4, 2025

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR-1139-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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