A Study of Navenibart (STAR-0215) in Participants With Hereditary Angioedema

NCT05695248 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2026-05-08

Study results available
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Summary

The goal of this clinical trial is to test the drug navenibart in participants with hereditary angioedema (HAE). One group of participants will get 1 dose of navenibart, and 2 other groups will get 2 doses of navenibart. Researchers will study the effects of navenibart in participants with HAE as this is the first time that the drug has been given to participants with HAE.

Conditions

Interventions

DRUG

Navenibart

Navenibart will be administered as a subcutaneous bolus injection.

Sponsors & Collaborators

  • Astria Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-21
Primary Completion
2025-03-13
Completion
2025-03-13
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Canada
  • Czechia
  • Germany
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05695248 on ClinicalTrials.gov