A Study of STAR-0310 in Healthy Adult Participants

Description

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.

Conditions

Healthy Participants

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

A First-in-Human, Phase 1a, Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, Single Ascending Dose Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of STAR-0310 in Healthy Adult Participants

A Study of STAR-0310 in Healthy Adult Participants

Condition
Healthy Participants
Intervention / Treatment

-

Contacts and Locations

Austin

Austin Clinical Research Unit - Early Clinical Development, Austin, Texas, United States, 78744

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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).
  • * 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

Ages Eligible for Study

18 Years to 60 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Astria Therapeutics, Inc.,

Study Record Dates

2026-01