ACTIVE_NOT_RECRUITING

A Study of STAR-0310 in Healthy Adult Participants

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official 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

Quick Facts

Study Start:2025-01-07

Study Completion:2026-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06782477

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.

Ages Eligible for Study:18 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Locations (Sites)

Austin Clinical Research Unit - Early Clinical Development

Austin, Texas, 78744

United States

Collaborators and Investigators

Sponsor: Astria Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-07

Study Completion Date2026-01

Study Record Updates

Study Start Date2025-01-07

Study Completion Date2026-01

Terms related to this study

Additional Relevant MeSH Terms

Healthy Participants