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STAR-0310

Phase 1

Undisclosed | Biologics | Other |Astria Therapeutics, Inc.|Trials Updated: Nov 4, 2025

STAR-0310 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jan 2025

STAR-0310 target and mechanism

Molecular targetOX40
Target classProtein
ModalityBiologics

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

STAR-0310 clinical trials

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
Healthy ParticipantsUnlock trial analytics

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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Frequently asked questions about STAR-0310

What is STAR-0310?

STAR-0310 is an investigational small molecule being developed by Astria Therapeutics, Inc. It is in Phase 1 clinical development and is designed to target OX40. The program is currently being evaluated in healthy adult volunteers rather than in a specific patient population.

What does STAR-0310 target?

STAR-0310 targets OX40, a protein target. OX40 is a receptor expressed on activated T cells and is studied as a costimulatory immune target. Astria Therapeutics is developing STAR-0310 as a small molecule directed at OX40, and the Phase 1 program is evaluating it in healthy adult participants.

Who makes STAR-0310?

STAR-0310 is being developed by Astria Therapeutics, Inc., which trades on the Nasdaq under the ticker ATXS. The company is the sponsor of the Phase 1 study of STAR-0310 in healthy adult participants in the United States.

What phase is STAR-0310 in?

STAR-0310 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Astria Therapeutics is running a single Phase 1 study of STAR-0310, which is currently active but no longer recruiting participants.

What clinical trials is STAR-0310 in?

STAR-0310 is being studied in one Phase 1 trial, NCT06782477, titled A Study of STAR-0310 in Healthy Adult Participants. The trial is active but not recruiting, is randomized, double blind, and controlled, and plans to enroll 40 healthy adult volunteers in the United States.

Is STAR-0310 tested in healthy volunteers?

Yes. The Phase 1 trial of STAR-0310, NCT06782477, enrolls healthy adult participants rather than patients with a specific disease. It is a randomized, double blind, controlled study of 40 participants aged 18 years and older, conducted in the United States, and it is currently active but not recruiting.