NCT03292302

Phase 1 Study of ELX-02 in Healthy Adults

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

Summary

Phase 1 Single Ascending Dose Study in Normal Healthy Volunteers

Detailed description

This is a 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 Disease
• Nonsense Mutation

Interventions

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

Timeline

• Start date: 2017-09-26
• Primary completion: 2017-12-15
• Completion: 2017-12-15
• First posted: 2017-09-25
• Last updated: 2023-08-22

Locations

1 site across 1 country: Belgium