NCT05431634

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Alumis Inc · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.)

Conditions

• Safety and Tolerability

Interventions

Type	Name	Description
DRUG	Experimental drug: ESK-001	Multiple doses of ESK-001
OTHER	Placebo	Placebo

Timeline

• Start date: 2022-05-12
• Primary completion: 2022-12-01
• Completion: 2022-12-31
• First posted: 2022-06-24
• Last updated: 2023-05-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study