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Study of BMN 349 Single Dose in PiZZ and PiMZ/MASH Adult Participants

StatusActive, Not Recruiting
PhasePhase 1
Started
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Record status
This record was last updated May 6, 2026 (before its estimated August 19, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary and study completion dates: Sep 2025 to Aug 19, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 12 to confirmed 6
    • Study sites: 8 to 7
    v10
  2. Primary completion date: Jul 2025 to Sep 2025
    • Study completion date: Aug 2025 to Sep 2025
    • Site details revised at 2 of 8 sites
    v9
  3. Study sites: 7 to 8v8
  4. Eligibility criteria revisedv7
  5. Study sites: 6 to 7v6
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  1. Site details revised at 1 of 6 sitesv5
  2. Study sites: 4 to 6
    • Eligibility criteria revised
    • Study title revised
    v4
  3. Start date: Dec 10, 2024 to Feb 21, 2025
    • Site details revised at 1 of 4 sites
    v3
  4. Study sites: 1 to 4
    • Start date changed from estimate of Dec 2024 to Dec 10, 2024
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to assess the safety and tolerability of a single oral dose of BMN 349 in participants with PiZZ or PiMZ/MASH. Primary outcome measures include incidence of any adverse events (including serious adverse events, dose limit toxicities, and adverse events of special interest), incidence of any laboratory test abnormalities, incidence of lung function test abnormalities and 12-lead ECG parameters. Participants will receive a single dose of either BMN 349 or placebo and then monitored for safety and tolerability.
Trial Details
NCT Number NCT06738017
Lead Sponsor BioMarin Pharmaceutical
Conditions
(from sponsor)		 Alpha 1-Antitrypsin Deficiency
Related terms alpha 1-Antitrypsin Deficiency
Enrollment 6 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov