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KB407

Phase 1

Cystic Fibrosis | Monoclonal antibody | Respiratory |Krystal Biotech, Inc.|Last Updated: May 7, 2026

Success Probability
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Market & Valuation
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Trial Design
CONTROLLEDDMC
Total Trials1
Total Enrollment20
FDA Designations
ORPHAN_DRUG
Clinical trial landscape

KB407 · 1 trial · 1 indication

Phase 1 1
NCT05504837A Study Assessing KB407 for the Treatment of Cystic FibrosisCystic Fibrosis
RECRUITING20 Analytics
PHASE1RECRUITING
A Study Assessing KB407 for the Treatment of Cystic Fibrosis
Cystic Fibrosis
NCT0550483720
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Study Endpoints
Primary Endpoints
To evaluate safety and tolerability of KB407 based upon assessment of adverse events (frequency, severity, relatedness), and changes from baseline in physical examinations, vital signs, ECG, and clinical laboratory test results
6 months

Number of adult subjects with treatment related adverse events as assessed by NCI-CTCAE v5

Secondary Endpoints
To evaluate the effects of KB407 on pulmonary function, as measured by change from baseline in absolute and percent predicted FEV1
6 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1 (open label)EXPERIMENTALA single administration of KB407
Cohort 2 (open label)EXPERIMENTALTwo administrations of KB407
Cohort 3 (open label)EXPERIMENTALFour administrations of KB407
Cohort 4 (open label)EXPERIMENTALFour consecutive administrations of KB407 followed by weekly administration for up to 6 months
Interventions
NameTypeDescription
KB407 (Nebulization)BIOLOGICALNebulized solution of KB407, a replication-defective HSV-1 expressing full length human CFTR
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: 1. The subject must have read, understood, and signed an Institutional Review Board/Ethics Committee (IRB/IEC) approved Informed Consent Form and must be able to and willing to follow study procedures and instructions 2. Subjects aged 18 years or older at the time of Informed Co...

Countries:United States
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Competitive Landscape -Cystic Fibrosis 18 trials
CompanyTickerTrialsLead PhaseDrugs
Vertex Pharmaceuticals IncorporatedVRTX9PHASE3VX-121/TEZ/D-IVA
Sionna Therapeutics, Inc.SION2PHASE2SION-719
BiomX Inc.PHGE1PHASE2BX004
Arcturus Therapeutics Holdings, Inc.ARCT1PHASE2ARCT-032
4D Molecular Therapeutics, Inc.FDMT1PHASE24D-710
Krystal Biotech, Inc.KRYS1PHASE1KB407
Illumina, Inc.ILMN1 - Undisclosed
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT05504837Enrollment: 12 → 20
LOWMay 24, 2026NCT05504837studyFirstPostDate: changed