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Active, Not Recruiting

NCT Number: NCT06782477

A Study of STAR-0310 in Healthy Adult Participants

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Austin Clinical Research Unit - Early Clinical Development

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

STAR-0310

Drug

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

Placebo

Drug

Placebo will be administered as a subcutaneous bolus injection.

Primary outcomes

  1. Number of Participants Experiencing Treatment-emergent Adverse Events

    Time frame: [Time Frame: Day 1 through Day 252]

Secondary outcomes

  1. Serum Concentration of STAR-0310

    Time frame: [Time Frame: Day 1 (predose up to 2 hours before study drug administration, and 12 hours post dose), Days 2, 3, 7, 10, 14, 21, 28, 42, 56, 84, 112, 140, 168, 196, 224, 252 ]

    Blood samples will be collected to measure the serum concentration of STAR-0310 before and after study drug administration.

  2. Number of Participants with Anti-drug Antibodies to STAR-0310

    Time frame: [Time Frame: Day 1 predose, Days 14, 28, 84, 168, 252 ]

    Blood samples will be collected to assess the formation of STAR-0310 anti-drug antibodies in serum before and after study drug administration.

Sponsors and collaborators

Lead sponsor

Astria Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 20, 2025
Registry last updated
Nov 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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