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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
Awards & highlights

Study Summary

This trial will test a new drug, ESK-001, to see if it is safe and effective in healthy people.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 14 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 14 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Adverse Events (AEs)
Incidence of Serious Adverse Events (SAEs)
Secondary outcome measures
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 more

Trial 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

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Alumis IncLead Sponsor
5 Previous Clinical Trials
876 Total Patients Enrolled
Mark BradleyStudy DirectorAlumis Inc

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available enrollment slots for this experiential research project?

"According to the clinicaltrials.gov platform, enrollment for this medical trial is ongoing. The study was initially posted on May 12th 2022 and has since been amended as recently as June 20th 2022."

Answered by AI

What potential side effects have been identified with ESK-001?

"As it is a Phase 1 study, with limited evidence of safety and efficacy, our team has judged the risk associated with ESK-001 to be low - scoring it an overall rating of 1."

Answered by AI

Can adults past the age of 25 participate in this experiment?

"Eligibility requirements state that participants must be at least 18 years of age and no older than 60 to join this trial."

Answered by AI

What aims does this clinical trial strive to achieve?

"This clinical trial will measure Serious Adverse Events (SAEs) over a fortnight-long period, as its primary outcome. The additional metrics evaluated include the compound's accumulation ratio for AUC(0-τ), apparent plasma elimination half-life (t½λz), and tyk2 pathway inhibition by ESK001 via evaluation of cytokine induction of pSTAT expression and downstream cytokine production - all within the span of 14 days."

Answered by AI

What is the aggregate number of participants in this medical experiment?

"Affirmative. According to data from clinicaltrials.gov, this medical trial is presently seeking participants; the listing was first uploaded on May 12th 2022 and updated for the final time on June 20th 2022. 48 subjects need to be recruited from a single research centre."

Answered by AI

Is there a possibility for me to be accepted into this medical study?

"This experimental work is including 48 individuals that are deemed safe and tolerable, ranging between 18 to 60 years old. The list of qualifications for consideration include being a man or woman within the specified age range, possessing good health as verified by medical history reviews, physical exams, vital signs test results and lab parameters. Additionally there may be other factors listed in the protocol that must be met prior to acceptance into the study."

Answered by AI
~17 spots leftby Apr 2025