Experimental drug: ESK-001 for Safety and Tolerability

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Alumis Central site, Glendale, CA
Safety and Tolerability
Experimental drug: ESK-001 - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
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Study Summary

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Safety and Tolerability

Study Objectives

2 Primary · 9 Secondary · Reporting Duration: Up to 14 days

Day 14
Cytokine induction of pSTAT expression and downstream cytokine production as a measure of tyk2 pathway inhibition by ESK001
Up to 14 days
Apparent clearance CL(Clearance)/F for ESK001 on Day 1
Apparent plasma elimination half-life (t½λz) for ESK001 on Day 1 and Day 14
Incidence of Adverse Events (AEs)
Incidence of Serious Adverse Events (SAEs)
The accumulation ratio for AUC(0-τ) (RAC AUC(0-τ)) for ESK001 on Day 14
The accumulation ratio for Cmax (RAC Cmax) for ESK001 on Day 14.
The area under plasma concentration-time curve from time zero extrapolated to last measurable concentration (AUCt) for ESK001 on Day 1 and Day 14
The area under the plasma concentration-curve over the dosing interval (AUC(0-τ)) for ESK001 on Day1 and Day 14
The observed maximum plasma concentration (Cmax) for ESK001 on Day 1 and Day 14.
The time to reach the observed maximum plasma concentration (tmax) for ESK001 on Day 1 and Day 14.

Trial Safety

Safety Progress

1 of 3

Other trials for Safety and Tolerability

Trial Design

2 Treatment Groups

Experimental Drug ESK-001
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

48 Total Participants · 2 Treatment Groups

Primary Treatment: Experimental drug: ESK-001 · Has Placebo Group · Phase 1

Experimental Drug ESK-001
Drug
Experimental Group · 1 Intervention: Experimental drug: ESK-001 · Intervention Types: Drug
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 14 days
Closest Location: Alumis Central site · Glendale, CA
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N/AFirst Recorded Clinical Trial
1 TrialsResearching Safety and Tolerability
0 CompletedClinical Trials

Who is running the clinical trial?

Alumis IncLead Sponsor
1 Previous Clinical Trials
15 Total Patients Enrolled
Mark BradleyStudy DirectorAlumis Inc

Eligibility Criteria

Age 18 - 65 · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are a man or woman between the ages of 18 and 60years, inclusive, at the Screening Visit.
You are healthy as determined by medical history, physical examination, vital signs, and routine laboratory parameters.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.