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

Alumis

Status and phase: Completed; Phase 1

Conditions: Safety and Tolerability

Treatments: Drug: Experimental drug: ESK-001; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05431634

ESK-001-003

Details and patient eligibility

About

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

Full 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.)

Enrollment: 49 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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49 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo for ESK-001

Treatment:

Other: Placebo

Experimental Drug ESK-001

Experimental group

Description:

Experimental Drug ESK-001

Treatment:

Drug: Experimental drug: ESK-001