NCT05431634

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2022

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 12, 2022

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 24, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

May 9, 2023

Status Verified

May 1, 2023

Enrollment Period

7 months

First QC Date

June 9, 2022

Last Update Submit

May 6, 2023

Conditions

Safety and Tolerability

Outcome Measures

Primary Outcomes (2)

  • 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 (9)

  • 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

  • The time to reach the observed maximum plasma concentration (tmax) for ESK001 on Day 1 and Day 14.

    Up to 14 days

  • Apparent plasma elimination half-life (t½λz) for ESK001 on Day 1 and Day 14

    Up to 14 days

  • +4 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo for ESK-001

Other: Placebo

Experimental Drug ESK-001

EXPERIMENTAL

Experimental Drug ESK-001

Drug: Experimental drug: ESK-001

Interventions

Experimental drug: ESK-001DRUG

Multiple doses of ESK-001

Experimental Drug ESK-001
PlaceboOTHER

Placebo

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Participant has a prior exposure to ESK-001
  • Participant has a history of hypersensitivity to any of the ingredients of ESK-001

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alumis Central site

Glendale, California, 91206, United States

Location

Study Officials

  • Mark Bradley

    Alumis Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2022

First Posted

June 24, 2022

Study Start

May 12, 2022

Primary Completion

December 1, 2022

Study Completion

December 31, 2022

Last Updated

May 9, 2023

Record last verified: 2023-05

Locations

US(1)