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CompletedNCT07051538Updated Jan 28, 2026

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 Phase 1 interventional study of SHR-1139 Injections and SHR-1139 Injections Placebo in Moderate to Severe Plaque Psoriasis, sponsored by Guangdong Hengrui Pharmaceutical Co., Ltd. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-28.

Sponsored by Guangdong Hengrui Pharmaceutical Co., Ltd · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Jun 2024, registered Jun 2025).
Phase
Phase 1
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Moderate to Severe Plaque Psoriasis
03

In context

Lead sponsor

Guangdong Hengrui Pharmaceutical Co., Ltd is the lead sponsor of 58 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
64 participants (actual)

Study arms

  • Experimental
    SHR-1139 Injections Group

    Drug: SHR-1139 Injections

  • Placebo comparator
    SHR-1139 Injections Placebo Group

    Drug: SHR-1139 Injections Placebo

Interventions

  • DrugSHR-1139 Injections

    SHR-1139 injections.

  • DrugSHR-1139 Injections Placebo

    SHR-1139 injections placebo

06

What researchers measure

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.

07

Study locations

1 site
  • Huashan Hospital, Fudan University
    Shanghai, Shanghai Municipality 200031, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07051538
Lead sponsor
Guangdong Hengrui Pharmaceutical Co., Ltd
Responsible party
Sponsor
First posted
Jul 4, 2025
Start date
Jun 26, 2024
Primary completion
Nov 28, 2025
Completion
Nov 28, 2025
Last update
Jan 28, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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