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Experimental drug: ESK-001

Phase 1

Safety and Tolerability | Small molecule | Other |Alumis Inc.|Last Updated: May 9, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment49

FDA Designations

No designations recorded

Clinical trial landscape

Experimental drug: ESK-001 · 1 trial · 1 indication

Phase 1 1
NCT05431634Multiple Dose Study to Determine Safety and Tolerability of ESK-001 in Healthy ParticipantsSafety and Tolerability
COMPLETED49 Analytics
PHASE1COMPLETED
Multiple Dose Study to Determine Safety and Tolerability of ESK-001 in Healthy Participants
Safety and Tolerability
NCT0543163449
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Study Endpoints

Primary Endpoints

Incidence of Adverse Events (AEs)
Up to 14 days

Safety and tolerability

Incidence of Serious Adverse Events (SAEs)
Up to 14 days

Safety and tolerability

Secondary Endpoints

The area under plasma concentration-time curve from time zero extrapolated to last measurable concentration (AUCt) for ESK001 on Day 1 and Day 14
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
Up to 14 days
The observed maximum plasma concentration (Cmax) for ESK001 on Day 1 and Day 14.
Up to 14 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORPlacebo for ESK-001
Experimental Drug ESK-001EXPERIMENTALExperimental Drug ESK-001

Interventions

NameTypeDescription
Experimental drug: ESK-001DRUGMultiple doses of ESK-001
PlaceboOTHERPlacebo
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 ...

Countries:United States
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Frequently asked questions about Experimental drug: ESK-001

What is ESK-001?

ESK-001 is an investigational small molecule being developed by Alumis Inc. (NASDAQ: ALMS). It is currently in Phase 1 clinical development. The drug is being studied for safety and tolerability, and it is not yet approved by the FDA.

What is ESK-001 used for?

ESK-001 is being studied for safety and tolerability in healthy participants. The Phase 1 trial is designed to assess the drug's safety profile, and it is not yet approved for any specific medical condition.

Who makes ESK-001?

ESK-001 is being developed by Alumis Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol ALMS. The company is conducting clinical trials to evaluate the safety and tolerability of this investigational small molecule.

What phase is ESK-001 in?

ESK-001 is in Phase 1 clinical development. The Phase 1 trial, which has been completed, was a multiple-dose study to determine the safety and tolerability of ESK-001 in healthy participants. The drug remains investigational and is not FDA approved.

What clinical trials is ESK-001 in?

ESK-001 has one completed Phase 1 clinical trial, identified as NCT05431634. This was a multiple-dose study to determine the safety and tolerability of ESK-001 in healthy participants. The trial was conducted in the United States, enrolled 49 participants, and was randomized, double-blind, and placebo-controlled.

Is ESK-001 FDA approved?

No, ESK-001 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed Phase 1 trial focused on safety and tolerability in healthy participants, and the drug has not yet been evaluated for efficacy in any disease condition.