Phase I Randomized Study of CPX for the Treatment of Adult Patients With Mild Cystic Fibrosis

• Status: Completed
• Trial end date: 1999-10-01
• Target enrollment: 0
• Participant gender: All

Summary

OBJECTIVES: I. Evaluate the safety of ascending doses of CPX administered to adult patients with mild cystic fibrosis.

II. Evaluate the pharmacokinetics of ascending doses of CPX in this patient population.

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

Details

• Lead Sponsor: FDA Office of Orphan Products Development
• Collaborator: SciClone Pharmaceuticals

Criteria

PROTOCOL ENTRY CRITERIA:

• Mild cystic fibrosis

• Not pregnant or nursing Negative pregnancy test