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Safety, Tolerability and Pharmacokinetics of CMS121, a Drug Candidate for Alzheimer's Disease, in Healthy Subjects — CMS121  

Alzheimer Disease Clinical Trial

Official title:
Phase 1 Study Evaluating Safety and Tolerability of Escalating Single and Multiple Doses of CMS121 and Food Effect in Healthy Volunteers

Clinical Trial Summary

This is a randomized, double-blind study of CMS121 or placebo given as single and multiple escalating doses in normal healthy subjects. The study will be conducted in 4 parts: Part 1 will be a SAD study enrolling approximately 48 young subjects for a total duration of 36 days. Part 2 will be a MAD study enrolling approximately 32 young subjects for a total duration of 43 days, and Part 3 will be a MAD study enrolling approximately 8 elderly subjects for 43 days. Part 4 will be an open-label SAD cross-over cohort of approximately 12 young subjects in a fed or fasted state to evaluate the effect of food on the bioavailability of CMS121, for a duration of 36 days.

Clinical Trial Description

This is a randomized, double-blind study of CMS121 or placebo given as single and multiple escalating doses in normal healthy subjects. The study will be conducted in 4 parts: Part 1 will be a SAD study enrolling approximately 48 young subjects for a total duration of approximately 36 days. Part 2 will be a MAD study enrolling approximately 32 young subjects for a total duration of approximately 43 days, and Part 3 will be a MAD study enrolling approximately 8 elderly subjects for a total duration of approximately 43 days. Part 4 will be an open-label SAD cross-over cohort of approximately 12 young subjects in fed and fasted states to evaluate the effect of food on the bioavailability of CMS121, for a duration of 36 days. Safety will be assessed by periodic measurement of vital signs, physical examinations, electrocardiograms (ECGs), blood and urine lab analyses and occurrence of adverse events (AEs). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05318040
Study type Interventional
Source Virogenics, Inc.
Contact
Status Completed
Phase Phase 1
Start date May 1, 2022
Completion date December 17, 2022
View Details
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