Recent Updates
Recently added Catalysts

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

Subscribe to view

Market & Valuation

Subscribe to view

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
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 ]
Unlock Study Endpoints

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.
Unlock Study Design Details

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
Unlock Eligibility Criteria

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 trial evaluating its safety and tolerability in this population. The drug is not yet approved and remains under investigation.

What does STAR-0310 target?

STAR-0310 targets OX40, a protein involved in immune responses. By targeting OX40, the drug may modulate immune activity, though its precise therapeutic application is still being explored in early-stage clinical trials.

Who makes STAR-0310?

STAR-0310 is being developed by Astria Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ATXS. The company is conducting a Phase 1 study of the drug in healthy volunteers.

What phase is STAR-0310 in?

STAR-0310 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 trial is designed to assess the drug's safety and pharmacokinetics in healthy participants.

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 randomized, double-blind, controlled study is enrolling 40 healthy adults aged 18 years and older in the United States.