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NCT06405633

A Phase 1b/2a, Open-label Single Ascending Doses and Multiple Ascending Doses Study in Participants With Pi*ZZ AATD

StatusRecruiting
PhasePhase 1/2
Primary completion (estimated)

At risk: Primary completion moved at least 11 months later.

See at-risk trials from Wave Life Sciences USA, Inc.

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Record History

All 7 versions: 7 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Sep 2026 to Sep 2027 Show 5 more changesShow less
    • Enrollment reopened
    • Enrollment increased: 24 → 48 participants
    • Trial arms changed: 3 → 5
    • Eligibility criteria expanded, about 14 words
    • Site details revised at 9 of 9 sites
  2. Changed Sponsor changed: Wave Life Sciences Ltd. to Wave Life Sciences USA, Inc.
  3. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 9 of 9 sites
    v6
  4. Primary and study completion dates: Jul 2025 to Sep 2026
    • Study sites: 6 to 9
    v5
  5. Study sites: 1 to 6v4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date changed from estimate of Jun 2024 to Jul 19, 2024v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

The proportion of participants with adverse events
Timeframe: Up to 36 Weeks

Secondary (6)

Single Ascending Dose - Change from baseline in levels of serum M-AAT protein.
Multiple Ascending Dose - Change from baseline in levels of serum M-AAT protein
Single Ascending Dose - Area under the plasma concentration time curve for WVE-006 from time of dosing to the last measurable concentration (AUClast)
Single Ascending Dose - Maximum concentration of WVE-006 in plasma
Multiple Ascending Doses - Area under the plasma concentration time curve for WVE-006 from time of dosing to the last measurable concentration (AUClast)
Show 1 moreShow less
Multiple Ascending Doses - Maximum concentration of WVE-006 in plasma (Cmax)

Arms and interventions

WVE-006 (Dose 1)Experimental
WVE-006 (Dose 2)Experimental
WVE-006 (Dose 3)Experimental
WVE-006 (Dose 4)Experimental
WVE-006 (Dose 5)Experimental

Drugs: WVE-006

Sites

9 sites in 6 countries

United Kingdom 3, Canada 2, Australia 1, Finland 1, Germany 1, New Zealand 1