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Completed Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT01695343

Public ClinicalTrials.gov record NCT01695343. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 27, 2026, 5:11 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01695343
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Humanigen, Inc.
Industry
Enrollment
182 participants

Conditions and interventions

Interventions

Biological · Drug

Eligibility (public fields only)

Age range
12 Years to 50 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 2012 (Type not available)
Primary completion
Nov 2014 (Actual)
Completion
Dec 2014 (Actual)
Last update posted
Jan 14, 2015

2012 – 2014

United States locations

U.S. sites
58
U.S. states
29
U.S. cities
55
Facility City State ZIP Site status
Not listed Mobile Alabama 36608 —
Not listed Phoenix Arizona 85016 —
Not listed Tucson Arizona 85724 —
Not listed Little Rock Arkansas 72205 —
Not listed Long Beach California 90806 —
Not listed Oakland California 94611 —
Not listed Orange California 92868 —
Not listed Stanford California 94304 —
Not listed Aurora Colorado 80045 —
Not listed Gainesville Florida 32610 —
Not listed Miami Florida 33136 —
Not listed Orlando Florida 32806 —
Not listed Tampa Florida 33606 —
Not listed Atlanta Georgia 30322 —
Not listed Boise Idaho 83712 —
Not listed Glenview Illinois 60025 —
Not listed Indianapolis Indiana 46202 —
Not listed Iowa City Iowa 52242 —
Not listed Lexington Kentucky 40536 —
Not listed Louisville Kentucky 40202 —
Not listed Portland Maine 04102 —
Not listed Boston Massachusetts 02115 —
Not listed Worchester Massachusetts 10655 —
Not listed Detriot Michigan 48201 —
Not listed Grand Rapids Michigan 49503 —
Not listed Minneapolis Minnesota 55455 —
Not listed Kansas City Missouri 64108 —
Not listed St Louis Missouri 63104 —
Not listed St Louis Missouri 63110 —
Not listed Hanover New Hampshire 03756 —
Not listed Manchester New Hampshire 03756 —
Not listed Albuquerque New Mexico 87131 —
Not listed Albany New York 12208 —
Not listed Hawthorne New York 10532 —
Not listed New Hyde Park New York 11040 —
Not listed New York New York 10032 —
Not listed Cincinnati Ohio 45229 —
Not listed Cincinnati Ohio 45267 —
Not listed Cleveland Ohio 44106 —
Not listed Columbus Ohio 43205 —
Not listed Dayton Ohio 45404 —
Not listed Toledo Ohio 43606 —
Not listed Oklahoma City Oklahoma 73104 —
Not listed Hershey Pennsylvania 17033 —
Not listed Philadelphia Pennsylvania 19102 —
Not listed Philadelphia Pennsylvania 19104 —
Not listed Pittsburgh Pennsylvania 15224 —
Not listed Charleston South Carolina 29425 —
Not listed Knoxville Tennessee 37916 —
Not listed Memphis Tennessee 38105 —
Not listed Nashville Tennessee 37232 —
Not listed Austin Texas 78723 —
Not listed Dallas Texas 75390 —
Not listed San Antonio Texas 78212 —
Not listed Colchester Vermont 05446 —
Not listed Richmond Virginia 23219 —
Not listed Madison Wisconsin 53792 —
Not listed Milwaukee Wisconsin 53226 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 9 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01695343, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 14, 2015 · Synced Oct 27, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01695343 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →