A Study of STAR-0310 in Healthy Adult Participants

NCT ID: NCT06782477

Last Updated: 2025-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-07

Study Completion Date

2026-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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STAR-0310 Dose 1

Participants will be randomized to receive STAR-0310 or matching placebo

Group Type EXPERIMENTAL

STAR-0310

Intervention Type DRUG

STAR-0310 will be administered as a subcutaneous bolus injection.

Placebo

Intervention Type DRUG

Placebo will be administered as a subcutaneous bolus injection.

STAR-0310 Dose 2

Participants will be randomized to receive STAR-0310 or matching placebo

Group Type EXPERIMENTAL

STAR-0310

Intervention Type DRUG

STAR-0310 will be administered as a subcutaneous bolus injection.

Placebo

Intervention Type DRUG

Placebo will be administered as a subcutaneous bolus injection.

STAR-0310 Dose 3

Participants will be randomized to receive STAR-0310 or matching placebo

Group Type EXPERIMENTAL

STAR-0310

Intervention Type DRUG

STAR-0310 will be administered as a subcutaneous bolus injection.

Placebo

Intervention Type DRUG

Placebo will be administered as a subcutaneous bolus injection.

STAR-0310 Dose 4

Participants will be randomized to receive STAR-0310 or matching placebo

Group Type EXPERIMENTAL

STAR-0310

Intervention Type DRUG

STAR-0310 will be administered as a subcutaneous bolus injection.

Placebo

Intervention Type DRUG

Placebo will be administered as a subcutaneous bolus injection.

STAR-0310 in Participants of Japanese Descent

Participants will be randomized to receive STAR-0310 or matching placebo

Group Type EXPERIMENTAL

STAR-0310

Intervention Type DRUG

STAR-0310 will be administered as a subcutaneous bolus injection.

Placebo

Intervention Type DRUG

Placebo will be administered as a subcutaneous bolus injection.

Interventions

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STAR-0310

STAR-0310 will be administered as a subcutaneous bolus injection.

Intervention Type DRUG

Placebo

Placebo will be administered as a subcutaneous bolus injection.

Intervention Type DRUG

Eligibility Criteria

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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 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
* Participants capable of producing sperm must use an effective method of contraception and abstain from sperm donation
* Healthy adults of Japanese descent, where both biological parents and all 4 biological grandparents are of Japanese ethnicity (applicable only for potential cohort of participants of Japanese descent).

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
* Taking any prescription or non-prescription medications within at least 5 half-lives or 7 days, whichever is longer, before the time of admission
* History of exposure to any biologic medication within 90 days or 5 half-lives, whichever is longer, before the time of admission
* Participation in a clinical trial involving receipt of an investigational product within 30 days (small molecule) or 90 days (biologics), or 5 half-lives, whichever is longer, before the time of admission
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Astria Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Austin Clinical Research Unit - Early Clinical Development

Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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STAR-0310-101

Identifier Type: -

Identifier Source: org_study_id

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