A Phase 2 interventional study of KB001-A and Placebo Comparator in Cystic Fibrosis, sponsored by Humanigen, Inc.. Completed at 67 sites in 4 countries. Open to participants aged 12 Years to 50 Years. Per ClinicalTrials.gov, last updated 2015-01-14.
Sponsored by Humanigen, Inc. · Phase 2, Interventional, and Treatment
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.
1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.
This study's enrollment of 182 is above the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →Humanigen, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
KB001-A administered up to 5x intravenously (IV) at 10 mg/kg up to a maximum dose of 800 mg per dose.
Biological: KB001-A
Placebo administered up to 5x intravenously
Drug: Placebo Comparator
To evaluate the effect of KB001-A on time-to-need for antibiotic (ABX) treatment for worsening of respiratory tract signs and symptoms.
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.
Time frame: 16 Weeks
Safety and tolerability of KB001-A
Safety and tolerability will be measured by Adverse Events (AEs) and laboratory assessments
Time frame: 16 Weeks
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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Humanigen, Inc.