NCT02807961

Safety, Tolerability, Pharmacokinetics of ELX-02 in Healthy Adult Volunteers

Phase 1a, Randomized, Double-blinded, Placebo-controlled, Single-dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ELX-02 in Healthy Adult Volunteers

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Eloxx Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is the first study in humans of ELX-02, an advanced synthetic aminoglycoside optimized as a translational read-through drug (TRID) for the treatment of genetic conditions caused by nonsense. mutations. This is a classical Phase 1a study designed as a randomized, double-blinded, placebo-controlled, single dose escalation to evaluate the safety, tolerability and pharmacokinetics of ELX-02 in healthy adult volunteers.

Conditions

• Genetic Diseases
• Nonsense Mutations

Interventions

Type	Name	Description
DRUG	ELX-02	Synthetic aminoglycoside
DRUG	Placebo	Placebo comparator

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-02-01
• Completion: 2017-05-01
• First posted: 2016-06-21
• Last updated: 2019-10-22