Overview

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

Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Humanigen, Inc.
KaloBios Pharmaceuticals
Criteria
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