Recent Updates
Recently added Catalysts

KB407

Phase 1

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

Target and mechanism

Molecular targetCFTR
Target classGene
ModalityMonoclonal antibody

Also known as KB407 (Nebulization)

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

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 FibrosisUnlock trial analytics

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
Unlock Study Endpoints

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
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about KB407

What is KB407 used for in Cystic Fibrosis?

KB407 is an investigational therapy being developed for the treatment of Cystic Fibrosis. It is administered via nebulization and is currently in Phase 1 clinical development. The drug is designed to address the underlying genetic cause of the disease by targeting the CFTR gene.

What does KB407 target?

KB407 targets the CFTR gene, which is the gene responsible for Cystic Fibrosis. By targeting this gene, KB407 aims to correct the underlying genetic defect that causes the disease. The therapy is delivered through nebulization and is currently being studied in a Phase 1 clinical trial.

Who makes KB407?

KB407 is being developed by Krystal Biotech, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol KRYS. The company is conducting a Phase 1 clinical trial to evaluate KB407 for the treatment of Cystic Fibrosis.

What phase is KB407 in?

KB407 is in Phase 1 clinical development. It is an investigational drug being studied for the treatment of Cystic Fibrosis and has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is currently recruiting participants in the United States.

What clinical trials is KB407 in?

KB407 is being evaluated in a Phase 1 clinical trial with the identifier NCT05504837, titled 'A Study Assessing KB407 for the Treatment of Cystic Fibrosis.' The trial is recruiting 20 participants aged 18 years and older in the United States and is currently in the recruiting stage.

Is KB407 the same as KB407 (Nebulization)?

Yes, KB407 is also known as KB407 (Nebulization), reflecting the method of administration. The drug is delivered via nebulization, which is a method of inhaling a mist to deliver medication directly to the lungs. This alternative name is used in clinical trial contexts.