RecruitingPhase 1

A Study Assessing KB407 for the Treatment of Cystic Fibrosis

United States20 participantsStarted 2023-06-30

Plain-language summary

This study will evaluate safety and tolerability of ascending doses of nebulized KB407 in adults with cystic fibrosis.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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
✓. Subjects aged 18 years or older at the time of Informed Consent
✓. A confirmed diagnosis of CF as defined by clinical signs and symptoms of CF and at least one of the following:
✓. Clinically stable in the opinion of the Investigator
✓. Percent predicted FEV1 ≥40% and ≤90% of the predicted normal for age, gender, and height at Screening
✓. Resting oxygen saturation ≥92% on room air at Screening

Exclusion criteria

✕. Initiation of any new chronic therapy (eg, CFTR modulator, hypertonic saline, inhaled antibiotic) or any change in chronic therapy (excluding pancreatic enzyme replacement therapy) within 28 days prior to the first dose
✕. 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
✕. Treatment for Mycobacterium abscessus within 3 months prior to the first dose or more than two pulmonary exacerbations with a history of Burkholderia cenocepacia infection within 6 months prior to the first dose
✕. 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
✕. History of or listed for solid organ transplantation
✕. 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
✕. An active oral herpes infection 30 days prior to the first dose
✕. Women who are pregnant or nursing

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

Timeframe: 6 months

Trial details

NCT IDNCT05504837

SponsorKrystal Biotech, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

David Sweet, MD, PhD

412-586-5830 dsweet@krystalbio.com

View on ClinicalTrials.gov More Cystic Fibrosis trials