Multiple Dose Study to Determine Safety and Tolerability... | NCT05431634

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

NCT05431634

Sponsor

Alumis Inc

Status

Completed

Last Update Posted

May 9, 2023Actual

Enrollment

49Actual

Phase

Phase 1

Conditions

Safety and Tolerability

Interventions

Experimental drug: ESK-001
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 12, 2022Actual

Primary Completion Date

Dec 1, 2022Actual

Completion Date

Dec 31, 2022Actual

First Submitted Date

Jun 9, 2022

First Submission Date that Met QC Criteria

Jun 20, 2022

First Posted Date

Jun 24, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 6, 2023

Last Update Posted Date

May 9, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

49Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Placebo for ESK-001	Other: Placebo
Experimental Drug ESK-001	Experimental	Experimental Drug ESK-001	Drug: Experimental drug: ESK-001

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Experimental drug: ESK-001	Drug	Multiple doses of ESK-001	Experimental Drug ESK-001

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of Adverse Events (AEs)	Safety and tolerability	Up to 14 days
Incidence of Serious Adverse Events (SAEs)	Safety and tolerability	Up to 14 days

Secondary Outcomes

Measure	Description	Time Frame
The area under plasma concentration-time curve from time zero extrapolated to last measurable concentration (AUCt) for ESK001 on Day 1 and Day 14	Pharmacokinetics	Up to 14 days
The area under the plasma concentration-curve over the dosing interval (AUC(0-τ)) for ESK001 on Day1 and Day 14

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mark Bradley	Alumis Inc	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Alumis Central site		Glendale	California	91206	United States