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A Study of KB407 for Cystic Fibrosis

This study is looking at a treatment called KB407 for adults with cystic fibrosis. KB407 is given as a nebulized solution, which means you breathe it in. It's a special type of virus (replication-defective HSV-1) that carries the full human CFTR gene, which is often faulty in people with cystic fibrosis. The main goal of this study is to see if KB407 is safe and how well people tolerate it. Researchers will check for any side effects and changes in your health over 6 months. This study plans to include 20 participants who are 18 years or older. The current status of the study is unclear.

Study design
This is an interventional study that plans to enroll 20 participants. It will evaluate ascending doses of KB407.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 6 months, indicating follow-up for at least this duration.

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NCT05504837

A Study Assessing KB407 for the Treatment of Cystic Fibrosis

Recruiting
PHASE1Ages 18+InterventionalTreatment
Krystal Biotech, Inc.
~20 participants
Updated 2026-05-07 on ClinicalTrials.gov
What's tested:KB407 (Nebulization)

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over 6 months

Conditions

Cystic Fibrosis

Explore related trials

Cystic FibrosisCFTR Gene

Where it's being run

6 sites across 5 states
New York2
Florida1
Idaho1
Illinois1
North Carolina1

Who to contact

David Sweet, MD, PhD
[email protected]
412-586-5830
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 ≤90% of the predicted normal for age, gender, and height at Screening 6. Resting oxygen saturation ≥92% on room air at Screening

What this trial measures

  • 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 results6 months

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