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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-12

Study Completion Date

2022-12-31

Brief Summary

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

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Detailed Description

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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

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Safety and Tolerability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Placebo for ESK-001

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

Experimental Drug ESK-001

Group Type EXPERIMENTAL

Experimental drug: ESK-001

Intervention Type DRUG

Multiple doses of ESK-001

Interventions

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Experimental drug: ESK-001

Multiple doses of ESK-001

Intervention Type DRUG

Placebo

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes