NCT04120233

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Linda Van Eldik · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

The primary objective of this trial is to assess the safety and tolerability of single ascending doses of MW151 when administered orally to healthy adults. Subjects will be screened prior to inpatient admission. Subjects will be admitted to the inpatient clinic on the day prior to dosing (Day -1) and will remain in the unit until discharge on Day 3. A follow-up visit will be done on Day 7. A single dose of study drug or placebo will be administered on Day 1. Healthy adult female subjects will be randomly assigned to one of 5 dose cohorts (8 subjects each). Each subject will receive a single dose of MW151 (10-160mg) or placebo under fasted conditions. Following a review of safety and tolerability data for the first 24 hours of dosing in each cohort (including reported adverse events (AEs), physical examination findings, clinical laboratory results, vital signs, and electrocardiograms (ECGs), the remaining 6 subjects will be randomized in a 5:1 ratio. Dosing of the remaining subjects in a cohort may proceed after review of sentinel subject safety data collected during the first 24 hours of dosing and determination that no stopping rules are met. The remaining subjects in each cohort will be dosed sequentially, not simultaneously.

Conditions

• Drug Toxicity

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-10-22
• Primary completion: 2021-09-16
• Completion: 2021-09-16
• First posted: 2019-10-09
• Last updated: 2022-12-30
• Results posted: 2022-12-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study