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RecruitingNCT07879170Updated Oct 16, 2026

A Single and Multiple Ascending Dose Study of EPX-100 in Healthy Adult Participants

A Phase 1 interventional study of EPX-100 and EPX-100-Matching Placebo in Healthy Participants, sponsored by Epygenix. Recruiting at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-16.

Sponsored by Epygenix · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Updated Oct 16, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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

Read the detailed 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.

02

Conditions studied

  • Healthy Participants

Keywords

  • Multiple Ascending Dose
  • Single Ascending Dose
03

In context

Lead sponsor

Epygenix is the lead sponsor of 5 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
88 participants (estimated)

Study arms

  • Experimental
    Part 1 SAD: EPX-100

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

    Drug: EPX-100

  • Placebo comparator
    Part 1 SAD: Placebo

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

    Drug: 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.

    Drug: EPX-100 · Drug: EPX-100-Matching Placebo · Drug: Moxifloxacin-Matching Placebo

  • 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.

    Drug: EPX-100-Matching Placebo · Drug: Moxifloxacin · Drug: Moxifloxacin-Matching Placebo

Interventions

  • DrugEPX-100

    Oral solution

    Also known as: clemizole, clemizole hydrochloride (HCL)

  • DrugEPX-100-Matching Placebo

    Oral Solution

  • DrugMoxifloxacin

    Over-encapsulated tablet

  • DrugMoxifloxacin-Matching Placebo

    Capsule

06

What researchers measure

Primary outcomes

  1. Number of Participants with Treatment Emergent Adverse Events (TEAEs) in Part 1 SAD

    Time frame: Part 1 SAD: up to Day 18

  2. Number of Participants with TEAEs in Part 2 MAD

    Time frame: Part 2 MAD: up to Day 31

Secondary outcomes

  1. Area Under the concentration-time curve (AUC), From Time 0 to The Last Observed Nonzero Concentration (AUC0-last) of EPX-100 and Metabolites in Plasma

    Time frame: Part 1 SAD: up to Day 4, Part 2 MAD: up to Day 17

  2. AUC0-last of EPX-100 and Metabolites in Urine

    Time frame: Part 1 SAD: up to Day 4

  3. Maximum Observed Concentration (Cmax) of EPX-100 and Metabolites in Plasma

    Time frame: Part 1 SAD: up to Day 4, Part 2 MAD: up to Day 17

  4. Cmax of EPX-100 and Metabolites in Urine

    Time frame: Part 1 SAD: up to Day 4

  5. Change from Baseline in Electrocardiogram (ECG) QT Interval Corrected According to the Method of Fridericia (QTcF)

    Time frame: Part 2 MAD: Baseline and up to Day 16

07

Study locations

1 of 1 sites recruiting
  • Celerion
    Tempe, Arizona 85283, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 16, 2026
Show all 1 update
  1. Oct 16, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07879170
Lead sponsor
Epygenix
Collaborators
Harmony Biosciences Management, Inc.
Responsible party
Sponsor
First posted
Oct 16, 2026
Start date
Aug 5, 2026
Primary completion
Dec 30, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Oct 16, 2026

Study contacts

Clinical Trials Administrator
Contact
clinicaltrials@harmonybiosciences.com
see email
Robert Faulkner, PhD
study director · Epygenix Therapeutics, Inc.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Clemizole hydrochloride

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