Skip to main content
OpenTrials
Completed

NCT Number: 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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Moderate to Severe Plaque Psoriasis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200031, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

SHR-1139 Injections

Drug

SHR-1139 injections.

SHR-1139 Injections Placebo

Drug

SHR-1139 injections placebo

Primary outcomes

  1. Adverse events (AEs)

    Time frame: About 365 days for moderate-to-severe plaque psoriasis subjects

  2. Adverse events (AEs)

    Time frame: About 295 days for healthy subjects.

  3. Serious adverse events (SAEs)

    Time frame: About 295 days for healthy subjects.

  4. Serious adverse events (SAEs)

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

Secondary outcomes

  1. Serum concentration of SHR-1139

    Time frame: About 253 days for healthy subjects.

  2. Serum concentration of SHR-1139

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

Sponsors and collaborators

Lead sponsor

Guangdong Hengrui Pharmaceutical Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 4, 2025
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.