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

Conditions

• Hereditary Angioedema

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Navenibart — DRUG
  Navenibart will be administered as a subcutaneous bolus injection.

Study Details

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.

Key Dates

Start date

Feb 21, 2023

Status verified

Apr 2026

Primary completion

Mar 13, 2025

Completion

Mar 13, 2025

Study Design

Enrollment

29 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1 - Single Dose
  Participants received 1 dose (450 milligrams \[mg\]) of navenibart.
• Experimental: Cohort 2 - Multiple Dose
  Participants received 2 doses (600 mg, 300 mg) of navenibart administered 3 months apart.
• Experimental: Cohort 3 - Multiple Dose
  Participants received 2 doses (600 mg) of navenibart administered 1 month apart.

Primary Outcome Measure

Number of Participants Experiencing Treatment-emergent Adverse Events [ Time Frame: Day 1 through Day 448 (Cohort 1), Day 531 (Cohort 2), Day 475 (Cohort 3) ]

Locations (13)

Find similar trials in Birmingham, AL

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