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

Overview

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

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: December 1, 2022

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

Interventions

  • Drug: Experimental drug: ESK-001
    • Multiple doses of ESK-001
  • Other: Placebo
    • Placebo

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo
    • Placebo for ESK-001
  • Experimental: Experimental Drug ESK-001
    • Experimental Drug ESK-001

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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
    • Pharmacokinetics
  • 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
    • Pharmacokinetics
  • The observed maximum plasma concentration (Cmax) for ESK001 on Day 1 and Day 14.
    • Time Frame: Up to 14 days
    • Pharmacokinetics
  • The time to reach the observed maximum plasma concentration (tmax) for ESK001 on Day 1 and Day 14.
    • Time Frame: Up to 14 days
    • Pharmacokinetics
  • Apparent plasma elimination half-life (t½λz) for ESK001 on Day 1 and Day 14
    • Time Frame: Up to 14 days
    • Pharmacokinetics
  • Apparent clearance CL(Clearance)/F for ESK001 on Day 1
    • Time Frame: Up to 14 days
    • Pharmacokinetics
  • The accumulation ratio for AUC(0-τ) (RAC AUC(0-τ)) for ESK001 on Day 14
    • Time Frame: Up to 14 days
    • Pharmacokinetics
  • The accumulation ratio for Cmax (RAC Cmax) for ESK001 on Day 14.
    • Time Frame: Up to 14 days
    • Pharmacokinetics
  • 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
    • Pharmacodynamics

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Alumis Inc
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Mark Bradley, Study Director, Alumis Inc

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