A Trial of SHR-1139 in Healthy Volunteers

Atridia

Status and phase: Enrolling; Phase 1

Conditions: Psoriasis

Treatments: Drug: SHR-1139 Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07078695

SHR-1139-102

Details and patient eligibility

About

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

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

SHR-1139 dose level 1

Experimental group

Description:

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

Treatment:

Drug: SHR-1139 Injection

Drug: SHR-1139 Injection

Drug: SHR-1139 Injection

SHR-1139 dose level 2

Experimental group

Description:

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

Treatment:

Drug: SHR-1139 Injection

Drug: SHR-1139 Injection

Drug: SHR-1139 Injection

SHR-1139 dose level 3

Experimental group

Description:

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

Treatment:

Drug: SHR-1139 Injection

Drug: SHR-1139 Injection

Drug: SHR-1139 Injection