CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 40 enrolled
Drug / intervention
Placebo +5 moredrug
Likely dose
MW151, 10mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04120233
NCT04120233Phase 1Completed
CompareCT.gov

A Phase 1a, Double-Blind, Randomized, Placebo-Controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of MW151 Administered Orally to Healthy Volunteers

Linda Van Eldik·interventional·Posted Oct 9, 2019·Updated Dec 30, 2022

In Brief

A Phase 1 clinical trial evaluating Placebo, MW151, 10mg, and 4 other interventions for Drug Toxicity. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDrug Toxicity
CountriesUnited States
CollaboratorsDuke Clinical Research Institute, National Institute on Aging (NIA)

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedOct 9, 2019
Enrollment StartOct 22, 2019
Primary CompletionSep 16, 2021
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 6.7 years ago

Interventions

Placebodrug

Matched placebo administered orally

MW151, 10mgdrug

10 mg MW151, 1 x 10mg capsule administered orally

MW151, 20mgdrug

20 mg MW151, 1 x 20mg capsule administered orally

MW151, 40mgdrug

40 mg MW151, 2 x 20mg capsule administered orally

MW151, 80mgdrug

80 mg MW151, 1 x 80mg capsule administered orally

MW151, 160mgdrug

160 mg MW151, 2 x 80mg capsule administered orally