A Study of STAR-0310 in Healthy Adult Participants

Phase 1

Recruiting

• Conditions: Healthy Participants
• Interventions: Drug: STAR-0310; Drug: Placebo

• Registration Number: NCT06782477
• Lead Sponsor: Astria Therapeutics, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01
• Study First Submitted: 2025-01-15
• Study First Submitted QC: 2025-01-15
• Last Update Submitted: 2025-01-15
• Study First Posted: 2025-01-20
• Last Update Posted: 2025-01-20
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
STAR-0310 Dose 1	Placebo	Participants will be randomized to receive STAR-0310 or matching placebo
STAR-0310 Dose 2	Placebo	Participants will be randomized to receive STAR-0310 or matching placebo
STAR-0310 Dose 3	Placebo	Participants will be randomized to receive STAR-0310 or matching placebo
STAR-0310 Dose 4	Placebo	Participants will be randomized to receive STAR-0310 or matching placebo
STAR-0310 in Participants of Japanese Descent	Placebo	Participants will be randomized to receive STAR-0310 or matching placebo
STAR-0310 Dose 1	STAR-0310	Participants will be randomized to receive STAR-0310 or matching placebo
STAR-0310 Dose 2	STAR-0310	Participants will be randomized to receive STAR-0310 or matching placebo
STAR-0310 Dose 3	STAR-0310	Participants will be randomized to receive STAR-0310 or matching placebo
STAR-0310 in Participants of Japanese Descent	STAR-0310	Participants will be randomized to receive STAR-0310 or matching placebo
STAR-0310 Dose 4	STAR-0310	Participants will be randomized to receive STAR-0310 or matching placebo

Primary Outcome Measures

Name	Time	Method
Number of Participants Experiencing Treatment-emergent Adverse Events	[Time Frame: Day 1 through Day 252]

Secondary Outcome Measures

Name	Time	Method
Serum Concentration of STAR-0310	[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.
Number of Participants with Anti-drug Antibodies to STAR-0310	[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.

Trial Locations

Locations (1)

Austin Clinical Research Unit - Early Clinical Development; 🇺🇸 Austin, Texas, United States