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Study to Evaluate the Effect of KB001-A on Time-to-Need for Antibiotic Treatment

NCT01695343 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2015-01-14

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

KB001-A

DRUG

Placebo Comparator

Sponsors & Collaborators

  • Humanigen, Inc.

    lead INDUSTRY

Principal Investigators

  • Nestor A. Molfino, MD., MSc · KaloBios Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2014-11-30
Completion
2014-12-31

Countries

  • United States
  • Australia
  • Israel
  • New Zealand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01695343 on ClinicalTrials.gov