Clinical trial NCT05431634: Multiple Dose Study to Determine Safety and Tolerability of ESK-001 in Healthy Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Safety and Tolerability
Lead sponsor: Alumis Inc
Sponsor class: INDUSTRY
First posted: 2022-06-24
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.)

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to 14 days
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: Up to 14 days
Secondary outcomes:
measure: The area under plasma concentration-time curve from time zero extrapolated to last measurable concentration (AUCt) for ESK001 on Day 1 and Day 14
timeFrame: Up to 14 days
measure: The area under the plasma concentration-curve over the dosing interval (AUC(0-τ)) for ESK001 on Day1 and Day 14
timeFrame: Up to 14 days
measure: The observed maximum plasma concentration (Cmax) for ESK001 on Day 1 and Day 14.
timeFrame: Up to 14 days
measure: The time to reach the observed maximum plasma concentration (tmax) for ESK001 on Day 1 and Day 14.
timeFrame: Up to 14 days
measure: Apparent plasma elimination half-life (t½λz) for ESK001 on Day 1 and Day 14
timeFrame: Up to 14 days
measure: Apparent clearance CL(Clearance)/F for ESK001 on Day 1
timeFrame: Up to 14 days
measure: The accumulation ratio for AUC(0-τ) (RAC AUC(0-τ)) for ESK001 on Day 14
timeFrame: Up to 14 days
measure: The accumulation ratio for Cmax (RAC Cmax) for ESK001 on Day 14.
timeFrame: Up to 14 days
measure: Cytokine induction of pSTAT expression and downstream cytokine production as a measure of tyk2 pathway inhibition by ESK001
timeFrame: 14 days after first dose
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Alumis Central site
state: California
Study officials:
affiliation: Alumis Inc
name: Mark Bradley
role: STUDY_DIRECTOR
References: