Cystic Fibrosis
Conditions
Keywords
Cystic Fibrosis, Pseudomonas aeruginosa (Pa), CF
Brief summary
The purpose of this study is to confirm and extend the Phase 1-2 KB001 findings of an airway anti-inflammatory effect in CF individuals with chronic Pseudomonas aeruginosa (Pa) airway infection. It is hypothesized that steady-state levels of KB001-A in CF subjects with airway Pa infection will be safe and well-tolerated, and will increase the time-to-need for antibiotic treatment (IV, inhaled, or oral) for worsening of respiratory tract signs and symptoms compared with placebo.
Interventions
BIOLOGICALKB001-A
DRUGPlacebo Comparator
Sponsors
Humanigen, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Individuals with CF who are older than 50 years of age may participate if treated with 2 or more courses of antibiotics (IV and/or oral) for respiratory sign and symptoms (CF exacerbation) in the 12 months before the Screening Visit * Confirmed diagnosis of CF * At least 2 respiratory tract cultures in the previous 12 months, with Pa present. The most recent positive Pa culture must be within 12 weeks before the Screening Visit (or obtain a positive culture at screening) * FEV1 % levels within acceptable ranges (per the study protocol) * Received inhaled ABX for equivalent of 8 weeks or greater in the 26 weeks before the Day 0 Visit
Exclusion criteria
* Treatment with antibiotics for acute illness within the 4 weeks before the Day 0 Visit * Use of systemic corticosteroids within the 4 weeks before the Day 0 Visit * Any change in regimen of CF maintenance therapies within the 4 weeks before the Day 0 Visit * History of sputum cultures positive for B. cepacia complex in the 2 years before the Screening Visit * History of organ transplantation * Current smoker (tobacco, marijuana, or any other material). Use of smokeless inhalers/vaporizers for these materials is also prohibited * History of drug addiction or alcohol abuse in the 12 months before the Screening Visit * History of hepatic disease (clinical cirrhosis or portal hypertension), renal dysfunction * Breast-feeding or pregnancy as evidenced by a positive blood pregnancy test * Receiving any investigational drug in the 16 weeks (or 5 half lives) before the Day 0 Visit, whichever is longer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the effect of KB001-A on time-to-need for antibiotic (ABX) treatment for worsening of respiratory tract signs and symptoms. | 16 Weeks | Time-to-need for ABX treatment will be the length of time between study material dosing and administration of ABX as needed for worsening respiratory conditions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of KB001-A | 16 Weeks | Safety and tolerability will be measured by Adverse Events (AEs) and laboratory assessments |
Countries
Australia, Israel, New Zealand, United States
Outcome results
None listed