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Serpentine-1

  • Status
    Accepting Candidates
  • Age
    18 Years - 70 Years
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

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 PIZZ or PIZNull genotype. Three planned dose levels of KB408 will be evaluated in single dose escalation cohorts. Subjects taking intravenous AAT augmentation therapy are not required to wash out from IV AAT in the low and mid dose cohorts. At the high dose, two cohorts will be conducted in parallel to evaluate patients on and off IV augmentation therapy.

Details

Full study title A Phase I Study of Inhaled KB408 for the Treatment of Alpha-1 Antitrypsin Deficiency
Protocol number OCR45916
ClinicalTrials.gov ID NCT06049082
Phase Phase 1

Eligibility

Inclusion Criteria:

  1. The subject or legally authorized representative must have read, understood, and signed an Institutional Review Board (IRB) approved Informed Consent Form and must be willing and able to comply with study procedures and instructions.

  2. Subject is aged 鈮�18 to 鈮�70 years, at the time of informed consent.

  3. Subject has a genetically confirmed diagnosis of AATD with a PIZZ or PIZNull genotype.

  4. Cohort 3b: Subjects receiving AAT augmentation therapy must be willing to washout for at least 6 weeks (42 days) prior to Screening and be willing to remain off augmentation therapy for the duration of the study.

  5. Cohort 3b: Serum AAT level

Lead researcher

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  2. Step
    2

    Get screened to confirm eligibility

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  4. Step
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