NCT07078695Active, not recruitingPhase 1
A Trial of SHR-1139 in Healthy Volunteers
A Phase 1, Randomized, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single Subcutaneous/Intravenous Administered SHR-1139 in Healthy Participants
Source: ClinicalTrials.gov · Last updated 19 Mar 2026
Brief summary (registry, in English)
The purpose of this study is to assess safety, PK and immunogenicity profile of a single dose of SHR-1139 in healthy volunteers
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 13 Jul 2025
- Start date
- 19 Aug 2025
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Atridia Pty Ltd.
- Diseases
- Psoriasis
- NCT number
- NCT07078695
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 24
- From 19 Aug 2025 to the primary completion date, 30 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- History or evidence of clinically significant disorders.
- 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.
Lab values
- 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
Other
- Unwilling or unable to comply with the Lifestyle Guidelines detailed in this protocol.
- Positive pregnancy test at screening or D-1/check-in.
Who the study is looking for
- Healthy white participants.
- 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.
- Male aged between 18 to 55 years of age (inclusive)
- 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.
- Men and WOCBP must agree to take highly effective contraceptive methods
Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Linear Coordinator of this site? Confirm its status | Perth | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.