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

NCT00004428 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2015-03-25

No results posted yet for this study

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.

Conditions

Interventions

DRUG

CPX

Sponsors & Collaborators

  • SciClone Pharmaceuticals

    collaborator INDUSTRY

  • FDA Office of Orphan Products Development

    lead FED

Principal Investigators

  • Eduardo Martins · SciClone Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-09-30
Completion
1999-10-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00004428 on ClinicalTrials.gov