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Clinical Trials in the USA / NCT06782477
Active, not recruiting Phase 1

A Study of STAR-0310 in Healthy Adult Participants

NCT06782477 · tracked via the Priya Life Science USA tracker
Sponsor
Astria Therapeutics, Inc.
Phase
Phase 1
Started
2025-01-07
Last updated
2025-11-04

Condition(s) studied

Healthy Participants

Investigational drug(s) / intervention(s)

STAR-0310Placebo

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

Placebo: Placebo will be administered as a subcutaneous bolus injection.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Austin Clinical Research Unit - Early Clinical Development Austin Texas

More Astria Therapeutics, Inc. trials in the USA

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06782477 on ClinicalTrials.gov ↗ ← All trials in the USA