Study Results
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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RECRUITING
PHASE1
24 participants
INTERVENTIONAL
2025-08-19
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SHR-1139 dose level 1
Single dose of SHR-1139 given subcutaneously (dose level 1)
SHR-1139 Injection
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)
SHR-1139 Injection
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)
SHR-1139 Injection
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 )
SHR-1139 Injection
Single dose of SHR-1139 given subcutaneously (dose level 2 )
SHR-1139 Injection
Single dose of SHR-1139 given intravenously (dose level 3)
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
55 Years
ALL
Yes
Sponsors
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Atridia Pty Ltd.
INDUSTRY
Responsible Party
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Locations
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Linear
Perth, Western Australia, Australia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SHR-1139-102
Identifier Type: -
Identifier Source: org_study_id
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