A Trial of SHR-1139 in Healthy Volunteers

NCT ID: NCT07078695

Last Updated: 2025-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-19

Study Completion Date

2026-09-30

Brief Summary

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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

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Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SHR-1139 dose level 1

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

Group Type EXPERIMENTAL

SHR-1139 Injection

Intervention Type DRUG

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

SHR-1139 dose level 2

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

Group Type EXPERIMENTAL

SHR-1139 Injection

Intervention Type DRUG

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

SHR-1139 dose level 3

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

Group Type EXPERIMENTAL

SHR-1139 Injection

Intervention Type DRUG

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

Interventions

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SHR-1139 Injection

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

Intervention Type DRUG

SHR-1139 Injection

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

Intervention Type DRUG

SHR-1139 Injection

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Atridia Pty Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Linear

Perth, Western Australia, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Kathy You

Role: CONTACT

+61 02 9299 0433

Facility Contacts

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Dr Jasmine Williams

Role: primary

1300 546 327

Other Identifiers

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SHR-1139-102

Identifier Type: -

Identifier Source: org_study_id

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