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STAR-0310

Phase 1

Healthy Participants | Small molecule | Other |Astria Therapeutics, Inc.|Last Updated: Nov 4, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06782477A Study of STAR-0310 in Healthy Adult ParticipantsPHASE1 ACTIVE NOT_RECRUITING 40Jan 7, 2025Jan 1, 2026Nov 4, 20251 United States
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Study Endpoints
Primary Endpoints
Number of Participants Experiencing Treatment-emergent Adverse Events
[Time Frame: Day 1 through Day 252]
Secondary Endpoints
Serum Concentration of STAR-0310
[Time Frame: Day 1 (predose up to 2 hours before study drug administration, and 12 hours post dose), Days 2, 3, 7, 10, 14, 21, 28, 42, 56, 84, 112, 140, 168, 196, 224, 252 ]
Number of Participants with Anti-drug Antibodies to STAR-0310
[Time Frame: Day 1 predose, Days 14, 28, 84, 168, 252 ]
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
STAR-0310 Dose 1EXPERIMENTALParticipants will be randomized to receive STAR-0310 or matching placebo
STAR-0310 Dose 2EXPERIMENTALParticipants will be randomized to receive STAR-0310 or matching placebo
STAR-0310 Dose 3EXPERIMENTALParticipants will be randomized to receive STAR-0310 or matching placebo
STAR-0310 Dose 4EXPERIMENTALParticipants will be randomized to receive STAR-0310 or matching placebo
STAR-0310 in Participants of Japanese DescentEXPERIMENTALParticipants will be randomized to receive STAR-0310 or matching placebo
Interventions
NameTypeDescription
STAR-0310DRUGSTAR-0310 will be administered as a subcutaneous bolus injection.
PlaceboDRUGPlacebo will be administered as a subcutaneous bolus injection.
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Good health as determined by the Investigator based upon a medical evaluation. * 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 po...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06782477primaryCompletionDate: changed
LOWMay 24, 2026NCT06782477studyFirstPostDate: changed