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Multiple Dose Study to Determine Safety and Tolerability of ESK-001 in Healthy Participants

Sponsor
Alumis Inc (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05431634
Collaborator
(none)
48
Enrollment
1
Location
2
Arms
7.7
Anticipated Duration (Months)
6.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Multiple Dose Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ESK-001 in Healthy Participants

Condition or Disease Intervention/Treatment Phase
  • Drug: Experimental drug: ESK-001
  • Other: Placebo
 Phase 1

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
May 12, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Placebo for ESK-001

Other: Placebo
Placebo
Experimental: Experimental Drug ESK-001

Experimental Drug ESK-001

Drug: Experimental drug: ESK-001
Multiple doses of ESK-001

Outcome Measures

Primary Outcome Measures

  1. Incidence of Adverse Events (AEs) [Up to 14 days]

    Safety and tolerability

  2. Incidence of Serious Adverse Events (SAEs) [Up to 14 days]

    Safety and tolerability

Secondary Outcome Measures

  1. The area under plasma concentration-time curve from time zero extrapolated to last measurable concentration (AUCt) for ESK001 on Day 1 and Day 14 [Up to 14 days]

    Pharmacokinetics

  2. The area under the plasma concentration-curve over the dosing interval (AUC(0-τ)) for ESK001 on Day1 and Day 14 [Up to 14 days]

    Pharmacokinetics

  3. The observed maximum plasma concentration (Cmax) for ESK001 on Day 1 and Day 14. [Up to 14 days]

    Pharmacokinetics

  4. The time to reach the observed maximum plasma concentration (tmax) for ESK001 on Day 1 and Day 14. [Up to 14 days]

    Pharmacokinetics

  5. Apparent plasma elimination half-life (t½λz) for ESK001 on Day 1 and Day 14 [Up to 14 days]

    Pharmacokinetics

  6. Apparent clearance CL(Clearance)/F for ESK001 on Day 1 [Up to 14 days]

    Pharmacokinetics

  7. The accumulation ratio for AUC(0-τ) (RAC AUC(0-τ)) for ESK001 on Day 14 [Up to 14 days]

    Pharmacokinetics

  8. The accumulation ratio for Cmax (RAC Cmax) for ESK001 on Day 14. [Up to 14 days]

    Pharmacokinetics

  9. Cytokine induction of pSTAT expression and downstream cytokine production as a measure of tyk2 pathway inhibition by ESK001 [14 days after first dose]

    Pharmacodynamics

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Alumis Central site Glendale California United States 91206

Sponsors and Collaborators

  • Alumis Inc

Investigators

  • Study Director: Mark Bradley, Alumis Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alumis Inc
ClinicalTrials.gov Identifier:
NCT05431634
Other Study ID Numbers:
  • ESK-001-003
First Posted:
Jun 24, 2022
Last Update Posted:
Jun 24, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 24, 2022