A Study of STAR-0215 in Healthy Adult Participants

Phase 1 Completed 41 enrolled Astria Therapeutics, Inc.

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start: 2022-07-27
Primary completion: 2023-11-17
Completion: 2023-11-17

Publications

Lumry W, Gunsior M, Cohen T, Bernard K, Gustafson P, Chung JK, Morabito C. Safety and pharmacokinetics of long-acting plasma kallikrein inhibitor navenibart (STAR-0215) in healthy adults. Ann Allergy Asthma Immunol. 2025 Jul;135(1):103-111.e2. doi: 10.1016/j.anai.2025.03.016. Epub 2025 Mar 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Navenibart	Monoclonal antibody	100 mg	Subcutaneous
Subject	Navenibart	Monoclonal antibody	1200 mg	Subcutaneous

A Study of STAR-0215 in Healthy Adult Participants

Summary

Timeline

Publications

Drugs

Indications