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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ACTIVE_NOT_RECRUITING
PHASE1
40 participants
INTERVENTIONAL
2025-01-07
2026-01-31
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
DOUBLE
Study Groups
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STAR-0310 Dose 1
Participants will be randomized to receive STAR-0310 or matching placebo
STAR-0310
STAR-0310 will be administered as a subcutaneous bolus injection.
Placebo
Placebo will be administered as a subcutaneous bolus injection.
STAR-0310 Dose 2
Participants will be randomized to receive STAR-0310 or matching placebo
STAR-0310
STAR-0310 will be administered as a subcutaneous bolus injection.
Placebo
Placebo will be administered as a subcutaneous bolus injection.
STAR-0310 Dose 3
Participants will be randomized to receive STAR-0310 or matching placebo
STAR-0310
STAR-0310 will be administered as a subcutaneous bolus injection.
Placebo
Placebo will be administered as a subcutaneous bolus injection.
STAR-0310 Dose 4
Participants will be randomized to receive STAR-0310 or matching placebo
STAR-0310
STAR-0310 will be administered as a subcutaneous bolus injection.
Placebo
Placebo will be administered as a subcutaneous bolus injection.
STAR-0310 in Participants of Japanese Descent
Participants will be randomized to receive STAR-0310 or matching placebo
STAR-0310
STAR-0310 will be administered as a subcutaneous bolus injection.
Placebo
Placebo will be administered as a subcutaneous bolus injection.
Interventions
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STAR-0310
STAR-0310 will be administered as a subcutaneous bolus injection.
Placebo
Placebo will be administered as a subcutaneous bolus injection.
Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) of 18 to 35 kg/m2 with a weight of at least 60 kg for men and at least 50 kg for women, with a maximum weight of 130 kg for any participant.
* Participants of childbearing potential must have a negative serum pregnancy test at Screening, agree to use highly effective forms of contraception and abstain from egg donation or fertility treatment
* Participants capable of producing sperm must use an effective method of contraception and abstain from sperm donation
* Healthy adults of Japanese descent, where both biological parents and all 4 biological grandparents are of Japanese ethnicity (applicable only for potential cohort of participants of Japanese descent).
Exclusion Criteria
* Known sensitivity to the ingredients of STAR-0310
* Taking any prescription or non-prescription medications within at least 5 half-lives or 7 days, whichever is longer, before the time of admission
* History of exposure to any biologic medication within 90 days or 5 half-lives, whichever is longer, before the time of admission
* Participation in a clinical trial involving receipt of an investigational product within 30 days (small molecule) or 90 days (biologics), or 5 half-lives, whichever is longer, before the time of admission
18 Years
60 Years
ALL
Yes
Sponsors
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Astria Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Austin Clinical Research Unit - Early Clinical Development
Austin, Texas, United States
Countries
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Other Identifiers
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STAR-0310-101
Identifier Type: -
Identifier Source: org_study_id
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