Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1
CB-280 twice daily at 50 mg for 14 days
  • Drug: CB-280
    CB-280, oral capsule administered twice daily at the assigned dose level for 14 days
Experimental
Cohort 2
CB-280 twice daily at 100 mg for 14 days
  • Drug: CB-280
    CB-280, oral capsule administered twice daily at the assigned dose level for 14 days
Experimental
Cohort 3
CB-280 twice daily at 200 mg for 14 days
  • Drug: CB-280
    CB-280, oral capsule administered twice daily at the assigned dose level for 14 days
Experimental
Cohort 4
CB-280 twice daily at 400 mg for 14 days
  • Drug: CB-280
    CB-280, oral capsule administered twice daily at the assigned dose level for 14 days
Placebo Comparator
Placebo
Placebo twice daily for 14 days
  • Drug: Placebos
    Placebo oral capsule administrated twice daily at the assigned dose level for 14 days

Recruiting Locations

University of Kansas Medical Center
Kansas City, Kansas 66160
Contact:
Megan White
913-588-6045

More Details

Status
Recruiting
Sponsor
Calithera Biosciences, Inc

Study Contact

Clinical Administrator
650-870-1000
clinicaltrials@calithera.com

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 Pseudomonas aeruginosa. The study will evaluate the safety, pharmacokinetics, pharmacodynamics, and biological activity of CB-280 in approximately 32 adult patients with cystic fibrosis. There are four planned sequential dose escalation cohorts of 8 subjects each, randomized 6:2 to receive CB-280 or matched placebo at doses of 50 mg, 100 mg, 200 mg, or 400 mg administered twice daily for 14 days. Intermediate dose levels may be evaluated based on emerging safety data at the planned dose levels.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.