Status:
COMPLETED
Study to Evaluate the Safety of CB-280 in Patients With Cystic Fibrosis
Lead Sponsor:
Calithera Biosciences, Inc
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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.
Detailed Description
Study CX-280-202 is a Phase 1b, randomized, double-blind, placebo-controlled, multiple ascending dose escalation study of CB-280 in adult subjects with cystic fibrosis and chronic infection with Pseud...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
July 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 23 2021
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04279769
Start Date
July 3 2020
End Date
November 23 2021
Last Update
April 13 2022
Active Locations (20)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
2
Long Beach Memorial Medical Center
Long Beach, California, United States, 90806
3
University of Florida
Gainesville, Florida, United States, 32610
4
The Cystic Fibrosis Institute
Glenview, Illinois, United States, 60025