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

Phase 1

Completed

• Conditions: Safety and Tolerability
• Interventions: Other: Placebo

• Registration Number: NCT05431634
• Lead Sponsor: Alumis Inc

Brief Summary

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 Timeline

• Study Start: 2022-05-12
• Study First Submitted: 2022-06-09
• Study First Submitted QC: 2022-06-20
• Study First Posted: 2022-06-24
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-31
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-06
• Last Update Posted: 2023-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo for ESK-001

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events (AEs)	Up to 14 days	Safety and tolerability
Incidence of Serious Adverse Events (SAEs)	Up to 14 days	Safety and tolerability

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Alumis Central site; 🇺🇸 Glendale, California, United States