Healthy VolunteerPhase 1NCT07378579
An Investigational Study to Evaluate the Cardiac Safety Assessment (TQTc Study) of ESK-001
A Phase 1 study testing ESK-001 and Moxifloxacin (400 mg) in people with Healthy Volunteer, run by Alumis Inc at 1 site in United States.
Trial summary
This a phase 1, partially blinded, randomized, crossover study to determine the pharmacokinetics (PK) and QT/QTc interval of study drug (ESK-001) in healthy volunteer 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 Volunteer
- What is being tested?
- ESK-001 and Moxifloxacin (400 mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2024to 31 Aug 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Healthy male and female subjects aged between 18 and 55 years, inclusive. Body mass index between ≥18.0 and ≤32.0 kg/m2, inclusive, and a minimum body weight of 45 kg.
- Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
- In good health, determined by no clinically significant findings from medical history, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations, and from the physical examination at screening or check-in, as assessed by the investigator (or designee).
- Serum sodium, potassium, calcium, and magnesium levels are within the normal range at screening and check-in-
Who cannot join
- Positive hepatitis panel and/or positive human immunodeficiency virus test, hepatitis B surface antigen, or hepatitis C antibodies.
- Alanine aminotransferase or aspartate aminotransferase >1.5 times the upper limit of normal, at screening or check-in.
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, as determined by the investigator (or designee).
- Surgery within the past three months prior to the first study drug administration determined by the principal investigator to be clinically relevant.
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair are allowed).
- History of Gilbert's syndrome or cholecystectomy surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Partially Blinded, Randomized, Crossover Study to Evaluate the Pharmacokinetics and QT/QTc Interval of ESK-001 Compared to Placebo and Moxifloxacin in Healthy Subjects
This a phase 1, partially blinded, randomized, crossover study to determine the pharmacokinetics (PK) and QT/QTc interval of study drug (ESK-001) in healthy volunteer participants,
Read the detailed description
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4) (A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)
- Conditions
- Healthy Volunteer
- Being tested
- ESK-001, Moxifloxacin (400 mg), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESK-001Drug
Single oral dose of ESK-001 in participants
Moxifloxacin (400 mg)Drug
positive control
PlaceboDrug
ESK-001-matched placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment 1: (Therapeutic dose) | Experimental | 1 oral dose of ESK-001 Receives: Drug: ESK-001 |
| Treatment 2: (Supratherapeutic dose) | Experimental | 1 oral dose of ESK-001 Receives: Drug: ESK-001 |
| Treatment 3: ESK-001-matched placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Treatment 4: (positive control) | Active comparator | Moxifloxacin 400 mg tablet Receives: Drug: Moxifloxacin (400 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in placebo-adjusted QTcF (∆∆QTcF)
Measured: 24 hours
Secondary outcomes (10)
Change from baseline in ECG parameter ΔHR
Measured: 24 hours
Change from baseline in ECG parameter Δ PR interval
Measured: 24 hours
Change from baseline in ECG parameter ΔQRS duration
Measured: 24 hours
Change from baseline in ECG parameter ΔQTc interval
Measured: 24 hours
Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE leading to discontinuation
Measured: Up to 22 Days
Number of clinically significant changes in clinical laboratory values, vital signs, ECGs, and physical examinations
Measured: Up to 22 Days
Composite of pharmacokinetic (PK) parameter Vz/F for ESK-001 and metabolites
Measured: 24 hours
Composite of pharmacokinetic (PK) parameter Cmax for ESK-001 and metabolites
Measured: 24 hours
Composite of pharmacokinetic (PK) parameter tmax for ESK-001 and metabolites
Measured: 24 hours
Composite of pharmacokinetic (PK) parameter CL/F for ESK-001 and metabolites
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start21 Jun 2024
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alumis Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jorn Drappa, MD, Ph.D., Study director, Alumis Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07378579
- Sponsor's protocol ID
- ESK-001-019
- Status last verified
- Jan 2026
- First submitted
- 10 Dec 2025
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The Sponsor Alumis Inc. is a clinical-stage pharmaceutical company that has not yet adopted an Individual Participant Data (IPD) sharing plan.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Partially Blinded, Randomized, Crossover Study to Evaluate the Pharmacokinetics and QT/QTc Interval of ESK-001 Compared to Placebo and Moxifloxacin in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07378579
- Acronym / sponsor ID
- ESK-001-019
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Alumis IncIndustry (pharma, biotech, devices)
- Study start
- 21 Jun 2024 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 30 Jan 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.
This a phase 1, partially blinded, randomized, crossover study to determine the pharmacokinetics (PK) and QT/QTc interval of study drug (ESK-001) in healthy volunteer participants,
Detailed description
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4) (A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment 1: (Therapeutic dose) | Experimental | Drug: ESK-0011 oral dose of ESK-001 |
| Treatment 2: (Supratherapeutic dose) | Experimental | Drug: ESK-0011 oral dose of ESK-001 |
| Treatment 3: ESK-001-matched placebo | Placebo comparator | Drug: Placebo |
| Treatment 4: (positive control) | Active comparator | Drug: Moxifloxacin (400 mg)Moxifloxacin 400 mg tablet |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male and female subjects aged between 18 and 55 years, inclusive. Body mass index between ≥18.0 and ≤32.0 kg/m2, inclusive, and a minimum body weight of 45 kg.
- Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
- In good health, determined by no clinically significant findings from medical history, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations, and from the physical examination at screening or check-in, as assessed by the investigator (or designee).
- Serum sodium, potassium, calcium, and magnesium levels are within the normal range at screening and check-in-
Key exclusion criteria (6 listed)
- Positive hepatitis panel and/or positive human immunodeficiency virus test, hepatitis B surface antigen, or hepatitis C antibodies.
- Alanine aminotransferase or aspartate aminotransferase >1.5 times the upper limit of normal, at screening or check-in.
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, as determined by the investigator (or designee).
- Surgery within the past three months prior to the first study drug administration determined by the principal investigator to be clinically relevant.
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair are allowed).
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 |
|---|---|---|
| ESK-001Single oral dose of ESK-001 in participants | Drug | Treatment 1: (Therapeutic dose), Treatment 2: (Supratherapeutic dose) |
| Moxifloxacin (400 mg)positive control | Drug | Treatment 4: (positive control) |
| PlaceboESK-001-matched placebo | Drug | Treatment 3: ESK-001-matched placebo |
Primary outcome
Change from baseline in placebo-adjusted QTcF (∆∆QTcF)
Time frame: 24 hours
10 secondary outcomes
Change from baseline in ECG parameter ΔHR
Time frame: 24 hours
Change from baseline in ECG parameter Δ PR interval
Time frame: 24 hours
Change from baseline in ECG parameter ΔQRS duration
Time frame: 24 hours
Change from baseline in ECG parameter ΔQTc interval
Time frame: 24 hours
Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE leading to discontinuation
Time frame: Up to 22 Days
Number of clinically significant changes in clinical laboratory values, vital signs, ECGs, and physical examinations
Time frame: Up to 22 Days
Composite of pharmacokinetic (PK) parameter Vz/F for ESK-001 and metabolites
Time frame: 24 hours
Composite of pharmacokinetic (PK) parameter Cmax for ESK-001 and metabolites
Time frame: 24 hours
Composite of pharmacokinetic (PK) parameter tmax for ESK-001 and metabolites
Time frame: 24 hours
Composite of pharmacokinetic (PK) parameter CL/F for ESK-001 and metabolites
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: Undecided. The Sponsor Alumis Inc. is a clinical-stage pharmaceutical company that has not yet adopted an Individual Participant Data (IPD) sharing plan.
Related trials for Healthy Volunteer
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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. This study is not recruiting at the moment.
Jorn Drappa, MD, Ph.D. study director
Alumis 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 ESK-001 and Moxifloxacin (400 mg) in people with Healthy Volunteer, run by Alumis Inc 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 6 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: finished, as of the sponsor's last update on 30 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in placebo-adjusted QTcF (∆∆QTcF) (time frame: 24 hours). 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 30 Jan 2026.