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Dose Escalation Study of KB001 in Cystic Fibrosis Patients Infected With Pseudomonas Aeruginosa

NCT00638365 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2014-06-09

Study results available
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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)

Conditions

Interventions

BIOLOGICAL

KB001

Single-dose, 3mg/kg or 10mg/kg dose administered intravenously

OTHER

Placebo

Placebo single-dose administered intravenously

Sponsors & Collaborators

  • Humanigen, Inc.

    lead INDUSTRY

Principal Investigators

  • Carlos Milla, MD · Stanford University

  • Nestor A. Molfino, MD, MSc · Humanigen, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2009-03-31
Completion
2009-04-30

Countries

  • United States

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 NCT00638365 on ClinicalTrials.gov