Recruiting
Phase 1

EPX-100

Sponsor:

Epygenix

Code:

NCT07879170

Conditions

Healthy Participants

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

EPX-100

EPX-100-Matching Placebo

Moxifloxacin

Moxifloxacin-Matching Placebo

Study Details

Brief summary:

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

Conditions

Healthy Participants

Study ID

NCT07879170

Start date

Aug 5, 2026

Status verified date

Oct, 2026

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

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 judged by the PI or designee at the Screening visit and at Check-In.

Exclusion Criteria:

  • History of cholecystectomy.
  • Has a family history of sudden cardiac death, unexplained death, or death from a primary dysrhythmia potentially associated with QT prolongation in any family member.
  • History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
  • History of seizure (excluding simple febrile seizure), epilepsy, severe head injury, multiple sclerosis, or other known neurological conditions that the PI or designee considers to be clinically significant.
  • History of presence of ventricular dysfunction or risk factors for Torsades de Pointes (e.g., heart failure, cardiomyopathy, family history of Long QT Syndrome or sudden unexpected cardiac death at a young age).
  • Part 2 only: history or presence of sick sinus syndrome, second or third degree atrioventricular block, myocardial infarction, pulmonary congestion, symptomatic or significant cardiac arrhythmia, prolonged QTcF interval, or conduction abnormalities.

Note: Additional inclusion/exclusion criteria may apply, per protocol.

Study Design

Enrollment

88 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1 SAD: EPX-100

Sequential cohorts of participants will receive a single ascending dose of EPX-100.

placebo comparator: Part 1 SAD: Placebo

Participants will receive a single dose of EPX-100-matching placebo.

experimental: Part 2 MAD: Treatment Arm

Participants will receive EPX-100 twice daily on Days 1 to 13, and a morning dose of EPX-100 on Day 14. Moxifloxacin-matching placebo will be administrated on Days 1 and 15. Participants will also receive a single dose of EPX-100-matching placebo on the morning of Days -1 and 15.

active comparator: Part 2 MAD: Control Arm

Participants will receive moxifloxacin or moxifloxacin-matching placebo on the morning of Day 1 then will cross over to the alternate treatment on the morning of Day 15.

EPX-100-matching placebo will be administered twice daily on Days 1 to 13 with a morning dose on Day 14. Participants will also receive a single dose of EPX-100-matching placebo on the morning of Days -1 and 15.

Interventions

EPX-100

Oral solution

EPX-100-Matching Placebo

Oral Solution

Moxifloxacin

Over-encapsulated tablet

Moxifloxacin-Matching Placebo

Capsule

Primary outcome measure

  • Number of Participants with Treatment Emergent Adverse Events (TEAEs) in Part 1 SAD [ Time Frame: Part 1 SAD: up to Day 18 ]
  • Number of Participants with TEAEs in Part 2 MAD [ Time Frame: Part 2 MAD: up to Day 31 ]

Central Contacts and Locations

Central contacts

Clinical Trials Administrator

see emailclinicaltrials@harmonybiosciences.com

Locations

Celerion

Recruiting

Tempe, Arizona, United States, 85283

More Information

Sponsor

Epygenix

Last update posted

Oct 16, 2026

Last verified

Oct, 2026

Keywords

  • Multiple Ascending Dose
  • Single Ascending Dose

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-17. This information was provided to ClinicalTrials.gov by Epygenix on 2026-10-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.