Safety and TolerabilityPhase 1NCT05431634
Multiple Dose Study to Determine Safety and Tolerability of ESK-001 in Healthy Participants
A Phase 1 study testing Experimental drug: ESK-001 in people with Safety and Tolerability, run by Alumis Inc at 1 site in United States.
Trial summary
Multiple Dose Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ESK-001 in Healthy Participants Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety and Tolerability
- What is being tested?
- Experimental drug: ESK-001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2022to 31 Dec 2022
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant is a man or woman between the ages of 18 and 60years, inclusive, at the Screening Visit
- Participant is healthy as determined by medical history, physical examination, vital signs, and routine laboratory parameters
- Other inclusions as specified in the protocol
Who cannot join
- Participant has a prior exposure to ESK-001
- Participant has a history of hypersensitivity to any of the ingredients of ESK-001
- Other exclusions as specified in the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Blinded, Randomized, Placebo-controlled, Multiple Dose Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ESK-001 Tablets Administered Over 14days to Healthy Participants
Multiple Dose Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ESK-001 in Healthy 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
- Safety and Tolerability
- Being tested
- Experimental drug: ESK-001, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental drug: ESK-001Drug
Multiple doses of ESK-001
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo for ESK-001 Receives: Other: Placebo |
| Experimental Drug ESK-001 | Experimental | Experimental Drug ESK-001 Receives: Drug: Experimental drug: ESK-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs)
Safety and tolerability
Measured: Up to 14 days
Incidence of Serious Adverse Events (SAEs)
Safety and tolerability
Measured: Up to 14 days
Secondary outcomes (9)
The area under plasma concentration-time curve from time zero extrapolated to last measurable concentration (AUCt) for ESK001 on Day 1 and Day 14
Pharmacokinetics
Measured: Up to 14 days
The area under the plasma concentration-curve over the dosing interval (AUC(0-τ)) for ESK001 on Day1 and Day 14
Pharmacokinetics
Measured: Up to 14 days
The observed maximum plasma concentration (Cmax) for ESK001 on Day 1 and Day 14.
Pharmacokinetics
Measured: Up to 14 days
The time to reach the observed maximum plasma concentration (tmax) for ESK001 on Day 1 and Day 14.
Pharmacokinetics
Measured: Up to 14 days
Apparent plasma elimination half-life (t½λz) for ESK001 on Day 1 and Day 14
Pharmacokinetics
Measured: Up to 14 days
Apparent clearance CL(Clearance)/F for ESK001 on Day 1
Pharmacokinetics
Measured: Up to 14 days
The accumulation ratio for AUC(0-τ) (RAC AUC(0-τ)) for ESK001 on Day 14
Pharmacokinetics
Measured: Up to 14 days
The accumulation ratio for Cmax (RAC Cmax) for ESK001 on Day 14.
Pharmacokinetics
Measured: Up to 14 days
Cytokine induction of pSTAT expression and downstream cytokine production as a measure of tyk2 pathway inhibition by ESK001
Pharmacodynamics
Measured: 14 days after first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start12 May 2022
- Primary completion1 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety and TolerabilityStudies 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
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alumis Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Bradley, Study director, Alumis Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05431634
- Sponsor's protocol ID
- ESK-001-003
- Status last verified
- May 2023
- First submitted
- 9 Jun 2022
- Last updated
- 9 May 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Blinded, Randomized, Placebo-controlled, Multiple Dose Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ESK-001 Tablets Administered Over 14days to Healthy Participants
- ClinicalTrials.gov ID
- NCT05431634
- Acronym / sponsor ID
- ESK-001-003
- Conditions
- Safety and Tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Alumis IncIndustry (pharma, biotech, devices)
- Study start
- 12 May 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 24 Jun 2022 (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.
Multiple Dose Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ESK-001 in Healthy 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
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboPlacebo for ESK-001 |
| Experimental Drug ESK-001 | Experimental | Drug: Experimental drug: ESK-001Experimental Drug ESK-001 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participant is a man or woman between the ages of 18 and 60years, inclusive, at the Screening Visit
- Participant is healthy as determined by medical history, physical examination, vital signs, and routine laboratory parameters
- Other inclusions as specified in the protocol
Key exclusion criteria (3 listed)
- Participant has a prior exposure to ESK-001
- Participant has a history of hypersensitivity to any of the ingredients of ESK-001
- Other exclusions as specified in the protocol
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 |
|---|---|---|
| Experimental drug: ESK-001Multiple doses of ESK-001 | Drug | Experimental Drug ESK-001 |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Incidence of Adverse Events (AEs)
Time frame: Up to 14 days
Safety and tolerability
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 14 days
Safety and tolerability
9 secondary outcomes
The area under plasma concentration-time curve from time zero extrapolated to last measurable concentration (AUCt) for ESK001 on Day 1 and Day 14
Time frame: Up to 14 days
The area under the plasma concentration-curve over the dosing interval (AUC(0-τ)) for ESK001 on Day1 and Day 14
Time frame: Up to 14 days
The observed maximum plasma concentration (Cmax) for ESK001 on Day 1 and Day 14.
Time frame: Up to 14 days
The time to reach the observed maximum plasma concentration (tmax) for ESK001 on Day 1 and Day 14.
Time frame: Up to 14 days
Apparent plasma elimination half-life (t½λz) for ESK001 on Day 1 and Day 14
Time frame: Up to 14 days
Apparent clearance CL(Clearance)/F for ESK001 on Day 1
Time frame: Up to 14 days
The accumulation ratio for AUC(0-τ) (RAC AUC(0-τ)) for ESK001 on Day 14
Time frame: Up to 14 days
The accumulation ratio for Cmax (RAC Cmax) for ESK001 on Day 14.
Time frame: Up to 14 days
Cytokine induction of pSTAT expression and downstream cytokine production as a measure of tyk2 pathway inhibition by ESK001
Time frame: 14 days after first dose
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 9 May 2023.
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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. This study is not recruiting at the moment.
Mark Bradley 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 Experimental drug: ESK-001 in people with Safety and Tolerability, 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 3 inclusion and 3 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 9 May 2023. 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?
Incidence of Adverse Events (AEs) (time frame: Up to 14 days). 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 9 May 2023.