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STAR-0310

Phase 1

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

Target and mechanism

Molecular targetOX40
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

STAR-0310 · 1 trial · 1 indication

Phase 1 1
NCT06782477A Study of STAR-0310 in Healthy Adult ParticipantsHealthy Participants
ACTIVE NOT_RECRUITING40 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Study of STAR-0310 in Healthy Adult Participants
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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 to 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

Frequently asked questions about STAR-0310

What is STAR-0310 used for?

STAR-0310 is an investigational small molecule being studied in healthy adult participants. It is currently in Phase 1 clinical development, with an active clinical trial evaluating its safety and tolerability. The drug is not yet approved and is still in the early stages of clinical research.

What does STAR-0310 target?

STAR-0310 targets OX40, a protein involved in immune responses. By targeting OX40, the drug may modulate immune system activity. However, its exact mechanism and therapeutic potential are still being investigated in early-stage clinical trials.

Who is developing STAR-0310?

STAR-0310 is being developed by Astria Therapeutics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol ATXS. The company is conducting a Phase 1 clinical trial to evaluate the drug in healthy participants.

What phase is STAR-0310 in?

STAR-0310 is in Phase 1 clinical development. It is currently being studied in a randomized, double-blind, controlled trial involving healthy adult participants in the United States. The drug is investigational and has not yet received regulatory approval.

What clinical trials is STAR-0310 in?

STAR-0310 is being evaluated in a Phase 1 clinical trial with the identifier NCT06782477, titled "A Study of STAR-0310 in Healthy Adult Participants." This active trial is enrolling 40 participants in the United States and is designed to assess the drug's safety and tolerability.