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Completed

NCT Number: NCT05431634

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

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

Completed

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Key information

Conditions

Safety and Tolerability

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Alumis Central site

Glendale, California, 91206, United States

About this study

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.)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental drug: ESK-001

Drug

Multiple doses of ESK-001

Placebo

Other

Placebo

Primary outcomes

  1. Incidence of Adverse Events (AEs)

    Time frame: Up to 14 days

    Safety and tolerability

  2. Incidence of Serious Adverse Events (SAEs)

    Time frame: Up to 14 days

    Safety and tolerability

Secondary outcomes

  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

    Time frame: 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

    Time frame: Up to 14 days

    Pharmacokinetics

  3. The observed maximum plasma concentration (Cmax) for ESK001 on Day 1 and Day 14.

    Time frame: Up to 14 days

    Pharmacokinetics

  4. 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

  5. Apparent plasma elimination half-life (t½λz) for ESK001 on Day 1 and Day 14

    Time frame: Up to 14 days

    Pharmacokinetics

  6. Apparent clearance CL(Clearance)/F for ESK001 on Day 1

    Time frame: Up to 14 days

    Pharmacokinetics

  7. The accumulation ratio for AUC(0-τ) (RAC AUC(0-τ)) for ESK001 on Day 14

    Time frame: Up to 14 days

    Pharmacokinetics

  8. The accumulation ratio for Cmax (RAC Cmax) for ESK001 on Day 14.

    Time frame: Up to 14 days

    Pharmacokinetics

  9. 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

Sponsors and collaborators

Lead sponsor

Alumis Inc

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 24, 2022
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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