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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Calithera Biosciences, Inc

Criteria

Inclusion Criteria:

1. Written Informed Consent in accordance with federal, local, and institutional guidelines

2. Confirmed diagnosis of cystic fibrosis

3. Male or female subjects ≥ 18 years on the date of informed consent

4. Percent predicted FEV1 of 40-90% at screening per Global Lung Function Initiative (GLI) equation

5. Clinically stable with no significant changes in health status within 28 days prior to Day 1

6. 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

7. Stable cystic fibrosis medication regimen for at least 28 days inclusive of CFTR modulators prior to Day 1

8. Hemoglobin > 10 g/dL at screening

9. Glomerular filtration rate > 50 mL/min/1.73 m2 at screening

10. Normal liver function at screening

Exclusion Criteria:

1. 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

2. 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)

3. Unable to receive study medication per os (PO)

4. Females who are pregnant, have a positive pregnancy test at screening, or are nursing (lactating)

Other protocol defined Inclusion/Exclusion criteria may apply.