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A Study of KB408 for the Treatment of Alpha-1 Antitrypsin Deficiency

Study acronym: Serpentine-1
StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 22, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Enrollment target: 12 to 15v7 Show 6 more changesShow less
    • Study sites: 2 to 3
    • Primary completion date: Jun 2025 to Dec 2025
    • Study completion date: May 2026 to Dec 2026
    • Secondary endpoints: details revised at 4 of 4 entries
    • Study arms: 3 to 4
    • Eligibility criteria expanded, about 4 words
  2. Study sites: 1 to 2v6
  3. Study completion date: Jun 2025 to May 2026
    • Eligibility criteria expanded, about 3 words
    v5
  4. Start date changed from estimate of Feb 2024 to Feb 15, 2024v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jan 2024 to Feb 2024
    • Site details revised
    v3
  6. Study title shortened, about 3 wordsv2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 Sponsor is developing KB408, a replication-defective, non-integrating herpes simplex virus type 1 (HSV-1)-derived vector engineered to deliver functional full-length human SERPINA1 to the airways of people with alpha-1 antitrypsin deficiency (AATD) via nebulization. This study is designed to evaluate safety and pharmacodynamics of KB408 in adults with AATD with a PI\*ZZ or PI\*ZNull genotype. Three planned dose levels of KB408 will be evaluated in single dose escalation cohorts. Repeat dosing will be evaluated at the mid dose level. Subjects taking intravenous AAT augmentation therapy are not required to wash out from IV AAT in the low and mid dose cohorts. In the repeat dose and the high dose cohorts, subjects must wash out from IV AAT for at least 10 days, as applicable.
Trial Details
NCT Number NCT06049082
Lead Sponsor Krystal Biotech, Inc.
Conditions
(from sponsor)		 Alpha 1-Antitrypsin Deficiency
Related terms alpha 1-Antitrypsin Deficiency
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov