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

Trial ID or NCT#

NCT01695343

Status

recruiting iconRECRUITING

Purpose

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.

Official Title

A Phase 2, Randomized, Double-blind, Placebo-controlled, Repeat-dose Study of KB001-A in Subjects With Cystic Fibrosis Infected With Pseudomonas Aeruginosa

Eligibility Criteria

Ages Eligible for Study: 12 Years to 50 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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

Contact us to find out if this trial is right for you.

Contact

Carlos Milla
650) 723-8325, (650) 736-9824