STAR-0310 for Healthy Subjects

Overseen ByClaire VanEenwyk, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Astria Therapeutics, Inc.

Must not be taking: Prescription, Non-prescription, Biologics

Disqualifiers: Medical condition, Sensitivity, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a randomized, double-blind, placebo-controlled, single ascending dose trial evaluating the safety, tolerability, PK, and immunogenicity of STAR-0310 in healthy adult participants. There are 4 planned cohorts and potentially up to 1 additional cohort which may comprise of healthy adult participants of Japanese descent.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any prescription or non-prescription medications at least 5 half-lives or 7 days before joining the trial, whichever is longer.

Are You a Good Fit for This Trial?

This trial is for healthy adults who may be interested in helping to test a new drug called STAR-0310. People of Japanese descent might also join an additional group. Participants must meet certain health requirements, but specific inclusion and exclusion criteria are not listed.

Inclusion Criteria

Good health as determined by the Investigator based upon a medical evaluation

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

My BMI is between 18 and 35, and my weight fits the trial's requirements.

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Exclusion Criteria

Prior or ongoing medical condition that, in the Investigator's opinion, could adversely affect the safety of the participant

Known sensitivity to the ingredients of STAR-0310

I haven't taken any medications within 5 half-lives or 7 days before joining.

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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single ascending dose of STAR-0310 or placebo

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety, tolerability, pharmacokinetics, and immunogenicity after treatment

36 weeks

Multiple visits (in-person) on Days 2, 3, 7, 10, 14, 21, 28, 42, 56, 84, 112, 140, 168, 196, 224, 252

What Are the Treatments Tested in This Trial?

Interventions

STAR-0310

Trial Overview The study is testing the safety and effects of STAR-0310 compared to a placebo (a treatment with no active drug). It's organized into different groups, where participants will receive either the real drug or placebo without knowing which one they get.

How Is the Trial Designed?

5Treatment groups

Experimental Treatment

Group I: STAR-0310 in Participants of Japanese DescentExperimental Treatment2 Interventions