A Study of STAR-0310 in Healthy Adult Participants

Running, not enrolling · Phase 1 · Has a placebo group

Conditions studied: Healthy Participants

In brief

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.

Key facts

Study ID

NCT06782477

Run by

Astria Therapeutics, Inc.

People needed

40

Starts

2025-01-07

Expected to finish

2026-01-01

Last updated by the study team

2025-11-04

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Austin Clinical Research Unit - Early Clinical Development — Austin, Texas, United States

Full record on ClinicalTrials.gov

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