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Clinical Trials in Australia / NCT07078695
Active, not recruiting Phase 1

A Trial of SHR-1139 in Healthy Volunteers

NCT07078695 · tracked via the Priya Life Science Australia tracker
Phase
Phase 1
Started
2025-08-19
Last updated
2026-03-19

Condition(s) studied

Psoriasis

Investigational drug(s) / intervention(s)

SHR-1139 Injection →SHR-1139 Injection →SHR-1139 Injection →

SHR-1139 Injection: Single dose of SHR-1139 given subcutaneously (dose level 1 )

SHR-1139 Injection: Single dose of SHR-1139 given subcutaneously (dose level 2 )

SHR-1139 Injection: Single dose of SHR-1139 given intravenously (dose level 3)

Study summary

The purpose of this study is to assess safety, PK and immunogenicity profile of a single dose of SHR-1139 in healthy volunteers

Eligibility

Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
Inclusion Criteria: 1. Healthy white participants. 2. Ability to understand the trial procedures and possible adverse events, volunteer to participate in the trial, and provide written informed consent, be able to comply with all the requirements, and able to complete the study. 3. Male aged between 18 to 55 years of age (inclusive) 4. Women with body weight ≥ 45.0 kg, men with body weight ≥ 50.0 kg, body mass index (BMI) between 18.0 and 30.0 kg/m2 (inclusive) at screening. 5. Men and WOCBP must agree to take highly effective contraceptive methods Exclusion Criteria: 1. History or evidence of clinically significant disorders. 2. Individuals with a history of drug allergies, specific allergies, or known history or suspected of being allergic to the study drug or any component of it. 3. Receipt of medical devices or another investigational drug (including placebo) within 3 months or 5 half-lives, or in the follow-up period of a clinical study, whichever is longer (according to the date of the signed consent form) prior to screening. 4. Unwilling or unable to comply with the Lifestyle Guidelines detailed in this protocol. 5. Positive pregnancy test at screening or D-1/check-in. 6. Any other circumstances (e.g., not suitable for venous access) or laboratory abnormality that, in the investigator's judgment, may increase the risk to the participant, or be associated with the participant's participation in and completion of the study or could preclude the evaluation of the participant's response. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Linear Perth Western Australia

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07078695 on ClinicalTrials.gov ↗ ← All trials in Australia