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MW151-101: First-in-human Study of MW151

NCT04120233 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-12-30

Study results available
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Summary

MW01-2-151SRM (=MW151), a small molecule, is being developed for the treatment of cognitive disorders. The development program is based on nonclinical evidence that MW151 improves neurocognitive outcomes in animal models of radiation-induced cognitive impairment, Alzheimer's disease, and other central nervous system (CNS) disorders.

The present study will provide safety and pharmacokinetic (PK) information on single ascending doses to support decisions for continued clinical development.

Conditions

  • Drug Toxicity

Interventions

DRUG

Placebo

Matched placebo administered orally

DRUG

MW151, 10mg

10 mg MW151, 1 x 10mg capsule administered orally

DRUG

MW151, 20mg

20 mg MW151, 1 x 20mg capsule administered orally

DRUG

MW151, 40mg

40 mg MW151, 2 x 20mg capsule administered orally

DRUG

MW151, 80mg

80 mg MW151, 1 x 80mg capsule administered orally

DRUG

MW151, 160mg

160 mg MW151, 2 x 80mg capsule administered orally

Sponsors & Collaborators

  • Duke Clinical Research Institute

    collaborator OTHER

  • National Institute on Aging (NIA)

    collaborator NIH

  • Linda Van Eldik

    lead OTHER

Principal Investigators

  • Linda J Van Eldik, PhD · University of Kentucky

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2019-10-22
Primary Completion
2021-09-16
Completion
2021-09-16
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 NCT04120233 on ClinicalTrials.gov