NCT06782477

A Study of STAR-0310 in Healthy Adult Participants

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Astria Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	STAR-0310	STAR-0310 will be administered as a subcutaneous bolus injection.
DRUG	Placebo	Placebo will be administered as a subcutaneous bolus injection.

Timeline

• Start date: 2025-01-07
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2025-01-20
• Last updated: 2025-11-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study