Actively Recruiting
A Study Assessing KB407 for the Treatment of Cystic Fibrosis
Led by Krystal Biotech, Inc. · Updated on 2026-05-07
20
Participants Needed
6
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will evaluate safety and tolerability of ascending doses of nebulized KB407 in adults with cystic fibrosis.
CONDITIONS
Official Title
A Study Assessing KB407 for the Treatment of Cystic Fibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must have signed an approved consent form and be willing to follow study procedures
- Age 18 years or older at consent
- Confirmed cystic fibrosis diagnosis by clinical signs and either a sweat chloride value over 60 mmol/L or two disease-causing CFTR gene mutations
- Clinically stable as judged by the Investigator
- Percent predicted FEV1 between 40% and 90% at screening
- Resting oxygen saturation of 92% or higher on room air at screening
You will not qualify if you...
- Started any new chronic therapy or changed chronic therapy (except pancreatic enzyme replacement) within 28 days before first dose
- Hospitalized, had sinopulmonary infection, CF exacerbation, or significant illness within 14 days before first dose
- Treated for Mycobacterium abscessus within 3 months prior or had more than two lung exacerbations with Burkholderia cenocepacia infection within 6 months prior to first dose
- Participated in another clinical study or used an investigational agent within 30 days or 5 half-lives before first dose
- History of or listed for solid organ transplant
- Any condition or history (including substance abuse, uncontrolled asthma, immunocompromised) that may affect ability to complete study or safety assessment
- Active oral herpes infection within 30 days before first dose
- Pregnant or nursing women
- Unwilling to follow contraception requirements
- Clinically significant blood or chemistry abnormalities at screening
- Known allergy to inhaled glycerol
- Known or expected noncompliance with study protocol
- For bronchoscopy participants: inability to tolerate bronchoscopy and airway sampling
- For Cohort 4: ineligible for, intolerant of, or not benefiting from modulator therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
University of Florida, Gainesville
Gainesville, Florida, United States, 32610
Actively Recruiting
2
St. Lukes CF Center of Idaho
Boise, Idaho, United States, 83712
Actively Recruiting
3
The Cystic Fibrosis Institute
Northfield, Illinois, United States, 60093
Actively Recruiting
4
New York Medical College/ Boston Children's Health Physicians
Hawthorne, New York, United States, 10532
Actively Recruiting
5
Northwell Health Physicians
New York, New York, United States, 10028
Actively Recruiting
6
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
Research Team
D
David Sweet, MD, PhD
CONTACT
B
Brittani Agostini, RN, CCRC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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