A Trial of SHR-1139 in Healthy Volunteers

Not Applicable

Not yet recruiting

• Conditions: Psoriasis
• Interventions: Drug: SHR-1139 Injection

• Registration Number: NCT07078695
• Lead Sponsor: Atridia Pty Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-13
• Study First Submitted QC: 2025-07-13
• Last Update Submitted: 2025-07-13
• Study First Posted: 2025-07-22
• Last Update Posted: 2025-07-22
• Study Start: 2025-08-26
• Primary Completion: 2026-09-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHR-1139 dose level 1	SHR-1139 Injection	Single dose of SHR-1139 given subcutaneously (dose level 1)
SHR-1139 dose level 2	SHR-1139 Injection	Single dose of SHR-1139 given subcutaneously (dose level 2)
SHR-1139 dose level 3	SHR-1139 Injection	Single dose of SHR-1139 given intravenously (dose level 3)

Primary Outcome Measures

Name	Time	Method
PK profile of SHR-1139 after a single administration	Start of Treatment to end of study (Day 253)	Pharmacokinetics-Terminal elimination half-life of SHR-1139 (t1/2)
PK profile of SHR-1139 after a single administration:	Start of Treatment to end of study (Day 253)	Pharmacokinetics- Time to Cmax of SHR-1139 (Tmax )
Immunogenicity profile of SHR-1139 after a single dose administration	Day 253	The number of participants with anti-drug antibody (ADA)

Secondary Outcome Measures

Name	Time	Method
Safety and Tolerability Based on Incidence and Severity of Treatment Emergent Adverse Events	Day 295	Number of participants with Adverse events and Serious adverse events

Trial Locations

Locations (1)

Linear; 🇦🇺 Perth, Western Australia, Australia