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 trial tests STAR-0310, a new treatment, to assess its safety and how the body processes it. It focuses on healthy adults and includes various doses to determine the optimal one. A special group in the trial involves healthy adults of Japanese descent. Individuals in good health who meet specific criteria, such as having a body mass index (BMI) between 18 and 35 and not taking certain medications, may qualify for this trial. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects on people.

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.

Is there any evidence suggesting that STAR-0310 is likely to be safe for humans?

Research has shown that STAR-0310 has been safe in earlier studies. Tested on healthy individuals, it was generally well-tolerated. These studies found that STAR-0310 remains in the body for an extended period without causing serious side effects. Instead, it effectively reduced cytokines, proteins that can lead to inflammation. Overall, the initial findings suggest that STAR-0310 is safe for humans. However, as this is an early-phase trial, further research is needed to fully understand its safety.¹ ² ³ ⁴ ⁵

Why do researchers think this study treatment might be promising?

Researchers are excited about STAR-0310 because it potentially offers a novel approach to treatment with its unique mechanism. While most treatments for similar conditions work by targeting specific enzymes or receptors, STAR-0310 could work by modulating a new pathway that hasn't been explored with current options. This difference might lead to improved effectiveness or fewer side effects. Additionally, the treatment is being explored in various dosages and even specifically in participants of Japanese descent, which could provide valuable insights into personalized medicine approaches.

What evidence suggests that STAR-0310 could be effective?

Research has shown that STAR-0310 could be a promising treatment due to its long-lasting effects. In earlier studies, STAR-0310 remained active in the body for up to 68 days and helped reduce cytokines, proteins that can cause inflammation. Importantly, initial tests in healthy individuals demonstrated that it is safe and well-tolerated. These findings suggest STAR-0310 could be useful for conditions where reducing inflammation is crucial.¹ ² ³ ⁴ ⁵

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.