Study to Evaluate the Safety of CB-280 in Patients With Cystic Fibrosis
A Phase 1b Randomized, Double-blind, Placebo-Controlled Trial to Evaluate the Safety of CB-280 in Patients With Cystic Fibrosis
1 other identifier
interventional
32
2 countries
20
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jul 2020
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2020
CompletedFirst Posted
Study publicly available on registry
February 21, 2020
CompletedStudy Start
First participant enrolled
July 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 23, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 23, 2021
CompletedApril 13, 2022
April 1, 2022
1.4 years
February 10, 2020
April 11, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determine the safety and tolerability of CB-280 in adult cystic fibrosis patients: incidence and severity of adverse event (AEs) assessed by Common Terminology Criteria for Adverse Events, version 5 (CTCAE v5.0)
Start of treatment to Day 28
Secondary Outcomes (2)
Pharmacokinetics of plasma CB-280 measured by Peak Plasma Concentration (Cmax)
Day 14
Pharmacokinetics of plasma CB-280 measured by area under the plasma concentration versus time curve, from time 0 to the last observed non-zero concentration (AUC 0-t)
Day 14
Study Arms (5)
Cohort 1
EXPERIMENTALCB-280 twice daily at 50 mg for 14 days
Cohort 2
EXPERIMENTALCB-280 twice daily at 100 mg for 14 days
Cohort 3
EXPERIMENTALCB-280 twice daily at 200 mg for 14 days
Cohort 4
EXPERIMENTALCB-280 twice daily at 400 mg for 14 days
Placebo
PLACEBO COMPARATORPlacebo twice daily for 14 days
Interventions
Eligibility Criteria
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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Long Beach Memorial Medical Center
Long Beach, California, 90806, United States
University of Florida
Gainesville, Florida, 32610, United States
The Cystic Fibrosis Institute
Glenview, Illinois, 60025, United States
Indiana University
Indianapolis, Indiana, 46202, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
Boston Children's Hospital, Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
Billings Clinic
Billings, Montana, 59101, United States
New York Medical College at Westchester Medical Center
Hawthorne, New York, 10532, United States
UNC Marsico Clinical Research Center
Chapel Hill, North Carolina, 27514, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Hershey Medical Center Pennsylvania State University
Hershey, Pennsylvania, 17033, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
University of Utah
Salt Lake City, Utah, 84132, United States
Vermont Lung Center at the University of Vermont Medical Center
Colchester, Vermont, 05446, United States
Virginia Commonwealth University
Richmond, Virginia, 23219, United States
University of Calgary
Calgary, Alberta, T2N 4N1, Canada
St. Pauls' Hospital
Vancouver, British Columbia, V6Z1Y6, Canada
McGill University Health Center
Montreal, Quebec, H4A 3J1, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Emil T Kuriakose, MD
Calithera Bioscience
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2020
First Posted
February 21, 2020
Study Start
July 3, 2020
Primary Completion
November 23, 2021
Study Completion
November 23, 2021
Last Updated
April 13, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share