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

(CMS121 Trial)

Overseen By Brandon Lester

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Virogenics, Inc.

Must not be taking: CYP inducers, QT prolongers

Disqualifiers: Cardiovascular, Psychiatric, Renal, others

Compensation: Varies

Number of Visits: Unknown

99 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

Yes, participants must stop taking any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements starting 14 days before the first dosing. Additionally, drugs that are significant inducers of certain enzymes must be stopped 28 days before the first dosing.

What is the purpose of this trial?

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.

Research Team

Scott Rasmussen, MD

Principal Investigator

Celerion

Eligibility Criteria

Inclusion Criteria

Capable of understanding the written informed consent document; willingly provides valid, signed written informed consent; willing and able to comply with the study schedule, requirements, and restrictions.

Continuous non smoker who has not used nicotine containing products for at least 3 months prior to the first dosing.

Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at the screening visit.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose (SAD)

Participants receive single escalating doses of CMS121 or placebo

36 days

Multiple visits for dosing and monitoring

Multiple Ascending Dose (MAD)

Participants receive multiple escalating doses of CMS121 or placebo

43 days

Multiple visits for dosing and monitoring

Open-label SAD Cross-over

Participants receive single doses of CMS121 in fed and fasted states to evaluate food effect

36 days

Multiple visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• CMS121

Participant Groups

Group I: Single ascending dose - CMS121 Experimental Treatment 1 Intervention

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

Group II: Multiple ascending dose - Elderly cohort - CMS121 Experimental Treatment 1 Intervention

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

Group III: Multiple ascending dose - CMS121 Experimental Treatment 1 Intervention

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

Group IV: Food Effect - CMS121 Experimental Treatment 1 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 - placebo Placebo Group 1 Intervention

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

Group VI: Multiple ascending dose - Elderly cohort - placebo Placebo Group 1 Intervention

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

Group VII: Multiple ascending dose - placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Virogenics, Inc.

Lead Sponsor

Trials

1

Recruited

100+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Celerion

Industry Sponsor

Trials

85

Recruited

7,600+

Dr. Susan Thornton

Celerion

Chief Executive Officer since 2010

PhD in Molecular Biology from the University of Pennsylvania

Dr. Lorraine M. Rusch

Celerion

Chief Medical Officer since 2020

MD from an unspecified institution