Healthy ParticipantsPhase 1NCT07879170
A Single and Multiple Ascending Dose Study of EPX-100 in Healthy Adult Participants
A Phase 1 study testing EPX-100 and Moxifloxacin in people with Healthy Participants, run by Epygenix at 1 site in United States.
Trial summary
A study to evaluate the safety and tolerability of single and multiple ascending doses of EPX-100 in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- EPX-100 and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2026to 30 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Celerion
Tempe, Arizona, 85283
About this study
Official title: 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
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.
- Conditions
- Healthy Participants
- Being tested
- EPX-100, EPX-100-Matching Placebo, Moxifloxacin, Moxifloxacin-Matching Placebo
- Keywords
- Multiple Ascending Dose, Single Ascending Dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPX-100Drug
Also called clemizole, clemizole hydrochloride (HCL)
Oral solution
EPX-100-Matching PlaceboDrug
Oral Solution
MoxifloxacinDrug
Over-encapsulated tablet
Moxifloxacin-Matching PlaceboDrug
Capsule
| Study group | Role | What they receive |
|---|---|---|
| Part 1 SAD: EPX-100 | Experimental | Sequential cohorts of participants will receive a single ascending dose of EPX-100. Receives: Drug: EPX-100 |
| Part 1 SAD: Placebo | Placebo comparator | Participants will receive a single dose of EPX-100-matching placebo. Receives: Drug: EPX-100-Matching Placebo |
| Part 2 MAD: Treatment Arm | Experimental | 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. Receives: Drug: EPX-100; Drug: EPX-100-Matching Placebo; Drug: Moxifloxacin-Matching Placebo |
| Part 2 MAD: Control Arm | Active comparator | 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. Receives: Drug: EPX-100-Matching Placebo; Drug: Moxifloxacin; Drug: Moxifloxacin-Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment Emergent Adverse Events (TEAEs) in Part 1 SAD
Measured: Part 1 SAD: up to Day 18
Number of Participants with TEAEs in Part 2 MAD
Measured: Part 2 MAD: up to Day 31
Secondary outcomes (5)
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
Measured: Part 1 SAD: up to Day 4, Part 2 MAD: up to Day 17
AUC0-last of EPX-100 and Metabolites in Urine
Measured: Part 1 SAD: up to Day 4
Maximum Observed Concentration (Cmax) of EPX-100 and Metabolites in Plasma
Measured: Part 1 SAD: up to Day 4, Part 2 MAD: up to Day 17
Cmax of EPX-100 and Metabolites in Urine
Measured: Part 1 SAD: up to Day 4
Change from Baseline in Electrocardiogram (ECG) QT Interval Corrected According to the Method of Fridericia (QTcF)
Measured: Part 2 MAD: Baseline and up to Day 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start5 Aug 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Epygenix
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Harmony Biosciences Management, Inc.
- Responsible party
- Sponsor
- Investigators
- Robert Faulkner, PhD, Study director, Epygenix Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07879170
- Sponsor's protocol ID
- EPX-100-CL-106
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07879170
- Acronym / sponsor ID
- EPX-100-CL-106
- Conditions
- Healthy Participants
- Keywords
- Multiple Ascending Dose, Single Ascending Dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- EpygenixIndustry (pharma, biotech, devices)
- Collaborators
- Harmony Biosciences Management, Inc.
- Study start
- 5 Aug 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 16 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to evaluate the safety and tolerability of single and multiple ascending doses of EPX-100 in healthy adult participants.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1 SAD: EPX-100 | Experimental | Drug: EPX-100Sequential cohorts of participants will receive a single ascending dose of EPX-100. |
| Part 1 SAD: Placebo | Placebo comparator | Drug: EPX-100-Matching PlaceboParticipants will receive a single dose of EPX-100-matching placebo. |
| Part 2 MAD: Treatment Arm | Experimental | Drug: EPX-100, Drug: EPX-100-Matching Placebo, Drug: Moxifloxacin-Matching PlaceboParticipants 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. |
| Part 2 MAD: Control Arm | Active comparator | Drug: EPX-100-Matching Placebo, Drug: Moxifloxacin, Drug: Moxifloxacin-Matching PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EPX-100Also: clemizole, clemizole hydrochloride (HCL)Oral solution | Drug | Part 1 SAD: EPX-100, Part 2 MAD: Treatment Arm |
| EPX-100-Matching PlaceboOral Solution | Drug | Part 1 SAD: Placebo, Part 2 MAD: Control Arm, Part 2 MAD: Treatment Arm |
| MoxifloxacinOver-encapsulated tablet | Drug | Part 2 MAD: Control Arm |
| Moxifloxacin-Matching PlaceboCapsule | Drug | Part 2 MAD: Control Arm, Part 2 MAD: Treatment Arm |
Primary outcome
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
5 secondary outcomes
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
AUC0-last of EPX-100 and Metabolites in Urine
Time frame: Part 1 SAD: up to Day 4
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
Cmax of EPX-100 and Metabolites in Urine
Time frame: Part 1 SAD: up to Day 4
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Faulkner, PhD study director
Epygenix Therapeutics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EPX-100 and Moxifloxacin in people with Healthy Participants, run by Epygenix at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Administrator (see email, clinicaltrials@harmonybiosciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.