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

Phase 1

Waitlist Available

Led By Scott Rasmussen, MD

Research Sponsored by Virogenics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline on day 1 and for 24hr post day 1 dose for sad cohorts; from baseline on day 1 and for 24hr post-dose after day 7 dose for mad cohorts.

Summary

This trial tests a new drug called CMS121 in healthy young and elderly people to see if it is safe and how it behaves in the body. Researchers will give different doses to understand its effects and any side effects. CMS121 is a drug candidate for Alzheimer's disease that has shown potential to prevent age-associated diseases in both brain and kidney.

Eligible Conditions

Alzheimer's Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline on day 1 and for 24hr post day 1 dose for sad cohorts; from baseline on day 1 and for 24hr post-dose after day 7 dose for mad cohorts.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline on day 1 and for 24hr post day 1 dose for sad cohorts; from baseline on day 1 and for 24hr post-dose after day 7 dose for mad cohorts.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline on day 1 and for 24hr post day 1 dose for sad cohorts; from baseline on day 1 and for 24hr post-dose after day 7 dose for mad cohorts. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Therapeutic procedure

Secondary study objectives

Safety: Effect on electrocardiographic parameters

Trial Design

7Treatment groups

Experimental Treatment

Placebo Group

Group I: Single ascending dose - CMS121Experimental Treatment1 Intervention

Subjects will receive a single oral dose of CMS121 under fed conditions.

Group II: Multiple ascending dose - Elderly cohort - CMS121Experimental Treatment1 Intervention

Subjects will receive multiple oral doses of CMS121 once daily (QD) for 7 days under fed conditions.

Group III: Multiple ascending dose - CMS121Experimental Treatment1 Intervention

Subjects will receive multiple oral doses of CMS121 once daily (QD) for 7 days under fed conditions.

Group IV: Food Effect - CMS121Experimental Treatment1 Intervention

On Day 1 of each of 2 treatment periods, a single oral dose of CMS121 will be administered following either a standard high fat/high calorie meal (Treatment A) or an overnight fast (Treatment B), as per each subject's assigned randomization sequence (AB or BA). There will be a washout of at least 7 days between doses.

Group V: Single ascending dose - placeboPlacebo Group1 Intervention

Subjects will receive a single oral dose of placebo under fed conditions.

Group VI: Multiple ascending dose - Elderly cohort - placeboPlacebo Group1 Intervention

Subjects will receive multiple oral doses of placebo once daily (QD) for 7 days under fed conditions.

Group VII: Multiple ascending dose - placeboPlacebo Group1 Intervention

Subjects will receive multiple oral doses of placebo once daily (QD) for 7 days under fed conditions.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CMS121

2022