A Study Assessing KB407 for the Treatment of Cystic Fibrosis
ConditionCystic Fibrosis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorKrystal Biotech, Inc.
About this trial
This study will evaluate safety and tolerability of ascending doses of nebulized KB407 in adults with cystic fibrosis.
Eligibility criteria
Qualifiers
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 historical sweat chloride value >60 mmol/L
Two copies of a disease causing mutation in the CFTR gene
Disqualifiers
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
Trial design
Treatments tested in this trial
- KB407 (Nebulization)
Treatment groups
20 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov