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

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

Study Overview

• Status: Completed
• Conditions: Safety and Tolerability
• Intervention / Treatment: Other: Placebo; Drug: Experimental drug: ESK-001

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 Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Glendale, California, United States, 91206
      • Alumis Central site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo for ESK-001	Other: Placebo; Placebo
Experimental: Experimental Drug ESK-001	Drug: Experimental drug: ESK-001; Multiple doses of ESK-001

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events (AEs)	Safety and tolerability	Up to 14 days
Incidence of Serious Adverse Events (SAEs)	Safety and tolerability	Up to 14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Up to 14 days
The observed maximum plasma concentration (Cmax) for ESK001 on Day 1 and Day 14.	Pharmacokinetics	Up to 14 days
The time to reach the observed maximum plasma concentration (tmax) for ESK001 on Day 1 and Day 14.	Pharmacokinetics	Up to 14 days
Apparent plasma elimination half-life (t½λz) for ESK001 on Day 1 and Day 14	Pharmacokinetics	Up to 14 days
Apparent clearance CL(Clearance)/F for ESK001 on Day 1	Pharmacokinetics	Up to 14 days
The accumulation ratio for AUC(0-τ) (RAC AUC(0-τ)) for ESK001 on Day 14	Pharmacokinetics	Up to 14 days
The accumulation ratio for Cmax (RAC Cmax) for ESK001 on Day 14.	Pharmacokinetics	Up to 14 days
Cytokine induction of pSTAT expression and downstream cytokine production as a measure of tyk2 pathway inhibition by ESK001	Pharmacodynamics	14 days after first dose

Collaborators and Investigators

• Sponsor: Alumis Inc
• Investigators: Study Director: Mark Bradley, Alumis Inc

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2022
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: June 9, 2022
• First Submitted That Met QC Criteria: June 20, 2022
• First Posted (Actual): June 24, 2022

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 6, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: ESK-001-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No