NCT05477160

A Study of STAR-0215 in Healthy Adult Participants

A First-in-Human, Phase 1a, Randomized, Double-Blind, Placebo Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of STAR-0215 in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Astria Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This is a first-in-human, single-center, randomized, double-blind, placebo-controlled, single ascending dose study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single subcutaneous (SC) or intravenous (IV) administration of STAR-0215 in healthy adult participants.

Conditions

• Hereditary Angioedema

Interventions

Type	Name	Description
DRUG	STAR-0215 (SC)	STAR-0215 will be administered as an SC bolus injection.
DRUG	Placebo (SC)	Placebo will be administered as an SC bolus injection.
DRUG	STAR-0215 (IV)	STAR-0215 will be administered as an IV bolus injection.
DRUG	Placebo (IV)	Placebo will be administered as an IV bolus injection.

Timeline

• Start date: 2022-07-27
• Primary completion: 2023-11-17
• Completion: 2023-11-17
• First posted: 2022-07-28
• Last updated: 2024-01-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study