At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 27 enrolled
Drug / intervention
KB001 +1 morebiological
Likely dose
KB001 3mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I/II Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose Escalation Study of KB001 in Cystic Fibrosis Patients Infected With Pseudomonas Aeruginosa
In Brief
A Phase 2 clinical trial evaluating KB001 and Placebo for Cystic Fibrosis. Completed, enrolled 27 participants across 11 sites.
Detailed Summary
The primary objective of this study is to evaluate the safety and tolerability of a single dose of KB001 in Cystic Fibrosis patients infected with Pseudomonas aeruginosa (Pa)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2008
First PostedMar 2008
Primary CompletionMar 2009
Study CompletionApr 2009
TodayJul 2026
First PostedMar 19, 2008
Enrollment StartMar 1, 2008
Primary CompletionMar 1, 2009
Study CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 18.3 years ago
Interventions
KB001biological
Single-dose, 3mg/kg or 10mg/kg dose administered intravenously
Placeboother
Placebo single-dose administered intravenously