A Trial of SHR-1139 in Healthy Volunteers

Launched by ATRIDIA PTY LTD. · Jul 13, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called SHR-1139 to see if it is safe for people to take. Although the medicine is being developed for psoriasis, a skin condition, this first study will include only healthy volunteers to understand how the body processes the drug and to check for any immune reactions after just one dose. The goal is to make sure the medication is safe before testing it in people with psoriasis.

To join the study, participants need to be healthy adults between 18 and 55 years old, with certain weight and body mass index (BMI) ranges. Both men and women can take part, but women who can have children must agree to use effective birth control during the study. People with serious health problems, allergies to the study drug, recent participation in other drug trials, or who are pregnant will not be eligible. Participants will be asked to follow study guidelines and give consent before joining. Since this is an early-stage trial, it focuses mainly on safety and how the drug behaves in the body rather than treating psoriasis symptoms.

Gender

ALL

Eligibility criteria

• 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