NCT04279769

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Calithera Biosciences, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	CB-280	CB-280, oral capsule administered twice daily at the assigned dose level for 14 days
DRUG	Placebos	Placebo oral capsule administrated twice daily at the assigned dose level for 14 days

Timeline

• Start date: 2020-07-03
• Primary completion: 2021-11-23
• Completion: 2021-11-23
• First posted: 2020-02-21
• Last updated: 2022-04-13

Locations

20 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study