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

Hengrui Medicine

Status and phase: Completed; Phase 1

Conditions: Moderate to Severe Plaque Psoriasis

Treatments: Drug: SHR-1139 Injections Placebo; Drug: SHR-1139 Injections

Study type: Interventional

Funder types: Industry

Identifiers

NCT07051538

SHR-1139-101

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups, including a placebo group

SHR-1139 Injections Group

Experimental group

Treatment:

Drug: SHR-1139 Injections

SHR-1139 Injections Placebo Group

Placebo Comparator group

Treatment:

Drug: SHR-1139 Injections Placebo