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A Phase 2 Study to Evaluate the Safety, Tolerability, PK and PD of ELX-02 in Cystic Fibrosis Patients With G542X Allele

Cystic Fibrosis Clinical Trial

Official title:
A Phase 2 Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dose Levels of Subcutaneously Administered ELX-02 in Patients With Cystic Fibrosis With at Least One G542X Allele

Clinical Trial Summary

This is a Phase 2 open-label, dose-escalation study to evaluate the safety, tolerability, PK, and PD of multiple dose levels of SC administered ELX-02 with and without ivacaftor in patients with CF with at least one G542X allele. In total, up to 16 patients will be enrolled in the trial; up to 4 patients will be homozygotes for G542X, and the remaining patients will be compound heterozygotes with one G542X or phenotypically similar nonsense allele and any Class 1 or Class 2 mutation. Each patient will receive up to 5 escalating doses as follows: - ELX-02 0.3 mg/kg per day SC - ELX-02 0.75 mg/kg per day SC - ELX-02 1.5 mg/kg per day SC - An individualized dose of ELX-02, as high as 3.0 mg/kg per day SC, based on the patients observed safety and tolerability, PK at previous doses and the results of laboratory tests. - ELX-02 1.5 mg/kg per day SC plus 150 mg ivacaftor every 12 bid

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04135495
Study type Interventional
Source Eloxx Pharmaceuticals, Inc.
Contact
Status Completed
Phase Phase 2
Start date November 25, 2019
Completion date October 3, 2022
View Details
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