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

NCT02807961 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2019-10-22

No results posted yet for this study

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

Interventions

DRUG

ELX-02

Synthetic aminoglycoside

DRUG

Placebo

Placebo comparator

Sponsors & Collaborators

  • Eloxx Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2017-02-28
Completion
2017-05-31

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Drugs
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 NCT02807961 on ClinicalTrials.gov