A Randomized, Double-Blind, Placebo-Controlled, Two-Part Study to Assess the Safety and Pharmacokinetics of Ascending Single and Multiple Doses of EPX-100 in Healthy Adult Participants

Epygenix

Summary

A study to evaluate the safety and tolerability of single and multiple ascending doses of EPX-100 in healthy adult participants.

Description

This is a two-part study. Part 1 is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics (PK) of EPX-100 following single ascending doses (SAD). Part 2 is a randomized, double-blind, placebo- and positive-controlled (active comparator) study to evaluate the safety, tolerability, and PK of EPX-100 following multiple ascending doses (MAD). In addition, cardiac liability will be evaluated in each cohort.

Eligibility

Age range: 18–55 years
Sex: All
Healthy volunteers: Yes

Detailed criteria

Inclusion Criteria: * Continuous nonsmoker who has not used nicotine- or tobacco-containing products for at least 3 months prior to (first) dosing. * Body mass index ≥18.0 and ≤32.0 kilograms per square meter(kg/m\^2) at the Screening visit (defined as within 28 days prior to dosing). * Medically healthy with no clinically significant medical history, physical examination findings, clinical laboratory profiles, vital signs, and electrocardiograms (ECGs), as deemed by the Principal Investigator (PI) or designee. * Part 2 only: No clinically significant history and presence of ECG findings as j…

Interventions

Drug
EPX-100
Oral solution
Drug
EPX-100-Matching Placebo
Oral Solution
Drug
Moxifloxacin
Over-encapsulated tablet
Drug
Moxifloxacin-Matching Placebo
Capsule

Location

Celerion
Tempe, Arizona

A Randomized, Double-Blind, Placebo-Controlled, Two-Part Study to Assess the Safety and Pharmacokinetics of Ascending Single and Multiple Doses of EPX-100 in Healthy Adult Participants

Summary

Description

Eligibility

Interventions

Location

Compensation

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Details

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