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

NCT00638365 | Completed Phase 1 Results DMC

• 1 other identifier: KB001-03
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 11

Brief 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

Cystic Fibrosis

Keywords

Cystic Fibrosis, Pseudomonas aeruginosa, Pulmonary CF

Outcome Measures

Primary Outcomes (1)

• The Safety and Tolerability of a Single-dose of KB001.

  Safety assessments were conducted after completion of day 28. AEs were followed through completion of day 56.

  Day 28

Study Arms (2)

1

EXPERIMENTAL

KB001, a monoclonal antibody

Biological: KB001

2

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

KB001 BIOLOGICAL

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

Also known as: KB001-recombinant human anti-Pa PcrV Fab antibody

1

Placebo OTHER

Placebo single-dose administered intravenously

2

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• Confirmed diagnosis of CF based on the following criteria:
• Positive sweat chloride greater than 60mEq/liter, and/or a genotype with 2 identifiable mutations consistent with CF, and one or more clinical features consistent with the CF phenotype
• Age \>/= 18 years of age with the potential for age 12 \>/=
• Screening Pa sputum culture
• FEV1% predicted \>/= 40 (based on Wang's equations for Males aged 12-17 and females 12-15 years, and Hankinson's equations for all other patients)

You may not qualify if:

• Evidence of an acute respiratory infection or pulmonary exacerbation within 4 weeks prior to day 0
• Use of systemic corticosteroids or antibiotics within 4 weeks prior to day 0, or cyclic inhaled antibiotics within 14 days prior to day 0.
• History of positive B. cepacia complex, organ transplantation, hepatic disease or venal dysfunction
• Current cigarette smoker, history of drug addiction or alcohol abuse
• Use of investigational medication or participation in an investigational study within 4 weeks prior to day 0
• Women who are pregnant or breastfeeding and patients and/or partner unwilling to use an effective form of barrier contraception throughout the study

Sponsors & Collaborators

• Humanigen, Inc.: lead

Study Sites (11)

University of Alabama

Birmingham, Alabama, 35233, United States

Location

Lucille Packard Children's Hospital at Stanford

Stanford, California, 94305, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Publications (1)

• Milla CE, Chmiel JF, Accurso FJ, VanDevanter DR, Konstan MW, Yarranton G, Geller DE; KB001 Study Group. Anti-PcrV antibody in cystic fibrosis: a novel approach targeting Pseudomonas aeruginosa airway infection. Pediatr Pulmonol. 2014 Jul;49(7):650-8. doi: 10.1002/ppul.22890. Epub 2013 Sep 9.

  PMID: 24019259 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis; Pseudomonas Infections

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Nestor A. Molfino, MD., MSc
• Organization: KaloBios Pharmaceuticals, Inc.

nmolfino@kalobios.com

650-243-3103

Study Officials

• Carlos Milla, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Nestor A. Molfino, MD, MSc

  Humanigen, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2008
• First Posted: March 19, 2008
• Study Start: March 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: April 1, 2009
• Last Updated: June 9, 2014
• Results First Posted: August 8, 2011

Record last verified: 2014-06

Locations

US (11)