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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-26

Study Completion Date

2025-11-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Moderate to Severe Plaque Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SHR-1139 Injections Group

Group Type EXPERIMENTAL

SHR-1139 Injections

Intervention Type DRUG

SHR-1139 injections.

SHR-1139 Injections Placebo Group

Group Type PLACEBO_COMPARATOR

SHR-1139 Injections Placebo

Intervention Type DRUG

SHR-1139 injections placebo

Interventions

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SHR-1139 Injections

SHR-1139 injections.

Intervention Type DRUG

SHR-1139 Injections Placebo

SHR-1139 injections placebo

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes