CompletedPhase 1

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

China64 participantsStarted 2024-06-26

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Adverse events (AEs)

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

Adverse events (AEs)

Timeframe: About 295 days for healthy subjects.

Serious adverse events (SAEs)

Timeframe: About 295 days for healthy subjects.

Serious adverse events (SAEs)

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

Trial details

NCT IDNCT07051538

SponsorGuangdong Hengrui Pharmaceutical Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-11-28

View on ClinicalTrials.gov More Moderate to Severe Plaque Psoriasis trials

Plain-language summary

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Adverse events (AEs)

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

Adverse events (AEs)

Timeframe: About 295 days for healthy subjects.

Serious adverse events (SAEs)

Timeframe: About 295 days for healthy subjects.

Serious adverse events (SAEs)

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