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Experimental drug: ESK-001 for Safety and Tolerability
Phase 1
Waitlist Available
Research Sponsored by Alumis Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 14 days
Summary
This trial tests a new drug called ESK-001 on healthy people to see if it is safe and well-tolerated. Researchers will study how the drug moves through the body and what effects it has.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 14 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 14 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of Adverse Events (AEs)
Incidence of Serious Adverse Events (SAEs)
Secondary study objectives
Apparent clearance CL(Clearance)/F for ESK001 on Day 1
Apparent plasma elimination half-life (t½λz) for ESK001 on Day 1 and Day 14
Cytokine induction of pSTAT expression and downstream cytokine production as a measure of tyk2 pathway inhibition by ESK001
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental Drug ESK-001Experimental Treatment1 Intervention
Experimental Drug ESK-001
Group II: PlaceboPlacebo Group1 Intervention
Placebo for ESK-001
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Experimental drug: ESK-001
2022
Completed Phase 1
~50
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Alumis IncLead Sponsor
7 Previous Clinical Trials
2,511 Total Patients Enrolled
Mark BradleyStudy DirectorAlumis Inc
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