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Single-Dose Escalation Study Followed by a Multiple-Dose Escalation Study of SKL24741 in Healthy Subjects

NCT04505397 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2023-12-21

No results posted yet for this study

Summary

This study evaluates SKL24741 safety and tolerability in healthy subjects. Subjects will be randomized to receive oral doses of SKL24741 or placebo. This is a two-part, double-blinded, randomized study of SKL24741.

Conditions

  • Healthy

Interventions

DRUG

SKL24741

An inhibitor of voltage-gated sodium channels and a possible activator of Big Potassium channels. Administered as an oral dose in the form of a capsule or tablet.

DRUG

Placebo

Sugar pill manufactured to mimic SKL24741

Sponsors & Collaborators

  • Spaulding Clinical Research LLC

    collaborator OTHER

  • Covance

    collaborator INDUSTRY

  • SK Life Science, Inc.

    lead INDUSTRY

Principal Investigators

  • Vijaykumar Vashi, PhD · SK Life Science, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-13
Primary Completion
2022-10-27
Completion
2022-10-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04505397 on ClinicalTrials.gov