A Study Assessing KB407 for the Treatment of Cystic Fibrosis
NCT ID: NCT05504837
Last Updated: 2025-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
12 participants
INTERVENTIONAL
2023-06-30
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohort 1 (open label)
A single administration of KB407
KB407 (Nebulization)
Nebulized solution of KB407, a replication-defective HSV-1 expressing full length human CFTR
Cohort 2 (open label)
Two administrations of KB407
KB407 (Nebulization)
Nebulized solution of KB407, a replication-defective HSV-1 expressing full length human CFTR
Cohort 3 (open label)
Four administrations of KB407
KB407 (Nebulization)
Nebulized solution of KB407, a replication-defective HSV-1 expressing full length human CFTR
Interventions
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KB407 (Nebulization)
Nebulized solution of KB407, a replication-defective HSV-1 expressing full length human CFTR
Eligibility Criteria
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Inclusion Criteria
2. Subjects aged 18 years or older at the time of Informed Consent
3. A confirmed diagnosis of CF as defined by clinical signs and symptoms of CF and at least one of the following:
* A historical sweat chloride value \>60 mmol/L
* Two copies of a disease causing mutation in the CFTR gene
4. Clinically stable in the opinion of the Investigator
5. Percent predicted FEV1 ≥40% and ≤100% of the predicted normal for age, gender, and height at Screening
6. Resting oxygen saturation ≥92% on room air at Screening
Exclusion Criteria
2. Hospitalization, sinopulmonary infection, CF exacerbation, or other clinically significant infection or illness 14 days prior to the first dose that, in the opinion of the Investigator, may confound study results
3. Treatment for Burkholderia cenocepacia, Burkholderia dolosa, or Nontuberculosis Mycobacteria infection within 3 months prior to the first dose
4. Participation in another clinical study or treatment with an investigational agent 30 days or 5 half-lives, whichever is longer, prior to the first dose
5. History of or listed for solid organ transplantation
6. Any condition (including a history or current evidence of substance abuse or dependence, uncontrolled asthma, or is considered to be immunocompromised) that, in the opinion of the Investigator, would impact a subject's ability to complete all study-related procedures and/or poses an additional risk to the assessment of safety of KB407
7. An active oral herpes infection 30 days prior to the first dose
8. Has received a vaccine within 72 hours prior to the first dose or has a planned vaccination during the treatment period
9. Women who are pregnant or nursing
10. Subject who is unwilling to comply with contraception requirements per protocol
11. Clinically significant abnormalities of hematology or chemistry testing at Screening that the Investigator believes may interfere with the assessment of safety and/or efficacy of the study treatment
12. Subject has a known hypersensitivity to inhaled glycerol
13. Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol in the opinion of the Investigator
14. Bronchoscopy participants only: Unable to tolerate bronchoscopy procedure and airway sampling, in the opinion of the Investigator
18 Years
ALL
No
Sponsors
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Krystal Biotech, Inc.
INDUSTRY
Responsible Party
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Locations
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University of Florida, Gainesville
Gainesville, Florida, United States
The Cystic Fibrosis Institute
Northfield, Illinois, United States
New York Medical College/ Boston Children's Health Physicians
Hawthorne, New York, United States
Northwell Health Physicians
New York, New York, United States
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KB407-02
Identifier Type: -
Identifier Source: org_study_id
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