Study to Evaluate the Safety of CB-280 in Patients With Cystic Fibrosis

Completed · Phase 1 · Has a placebo group

Conditions studied: Cystic Fibrosis

In brief

This is a phase 1b multiple ascending dose escalation study to evaluate the safety and tolerability of arginase inhibitor CB-280 in subjects with cystic fibrosis.

Key facts

Study ID

NCT04279769

Run by

Calithera Biosciences, Inc

People needed

32

Starts

2020-07-03

Expected to finish

2021-11-23

Last updated by the study team

2022-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written Informed Consent in accordance with federal, local, and institutional guidelines
• Confirmed diagnosis of cystic fibrosis
• Male or female subjects ≥ 18 years on the date of informed consent
• Percent predicted FEV1 of 40-90% at screening per Global Lung Function Initiative (GLI) equation
• Clinically stable with no significant changes in health status within 28 days prior to Day 1
• Chronic lung infection with P. aeruginosa defined as at least one positive culture in the last two years and more than 50% of cultures positive since then
• Stable cystic fibrosis medication regimen for at least 28 days inclusive of CFTR modulators prior to Day 1
• Hemoglobin > 10 g/dL at screening
• Glomerular filtration rate > 50 mL/min/1.73 m2 at screening
• Normal liver function at screening

You may not qualify if…

• History of any comorbidity that, in the opinion of the Investigator, might pose an additional risk in administering study drug to the subject or confound the results of the study
• Lung infection with organisms associated with a more rapid decline in pulmonary status (including, but not limited to, Burkholderia cenocepacia, Burkholderia dolosa, and Mycobacterium abscessus)
• Unable to receive study medication per os (PO)
• Females who are pregnant, have a positive pregnancy test at screening, or are nursing (lactating)
• Other protocol defined Inclusion/Exclusion criteria may apply.

Where it is running

• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Long Beach Memorial Medical Center — Long Beach, California, United States
• University of Florida — Gainesville, Florida, United States
• The Cystic Fibrosis Institute — Glenview, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Boston Children's Hospital, Brigham & Women's Hospital — Boston, Massachusetts, United States
• Billings Clinic — Billings, Montana, United States
• New York Medical College at Westchester Medical Center — Hawthorne, New York, United States
• UNC Marsico Clinical Research Center — Chapel Hill, North Carolina, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Hershey Medical Center Pennsylvania State University — Hershey, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• University of Utah — Salt Lake City, Utah, United States
• Vermont Lung Center at the University of Vermont Medical Center — Colchester, Vermont, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• University of Calgary — Calgary, Alberta, Canada
• St. Pauls' Hospital — Vancouver, British Columbia, Canada
• McGill University Health Center — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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