RecruitingPhase 1NCT07824271

Safety and Pharmacokinetics of ALZ-507 in Healthy Elderly Adults

A Phase 1, Single-Center, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability and Pharmacokinetics in Plasma, Urine and CSF of Single and Multiple Ascending Doses of ALZ-507 in Healthy Participants


Sponsor

Alzheon Inc.

Enrollment

84 participants

Start Date

Mar 9, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Researchers are testing an investigational medicine called ALZ-507 in healthy adults between 50 and 75 years of age. The purpose of this study is to learn: Assess if oral ALZ-507 is safe What side effects may occur How the body absorbs ALZ-507 Whether food affects how ALZ-507 is absorbed How much ALZ-507 reaches the blood, cerebrospinal fluid, and urine Participants will receive either ALZ-507 or a placebo. Some participants will receive a single dose, while others will receive daily doses for two weeks. Researchers will monitor participants closely through medical examinations, laboratory testing, and collection of blood, cerebrospinal fluid and urine. The findings from this study will help guide the future development of ALZ-507. The information from this study will help determine whether ALZ-507 is safe for further clinical development.


Eligibility

Min Age: 50 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called ALZ-507 and a drug called Placebo for people with healthy participants study. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGALZ-507

Participants will receive ALZ-507 oral capsules administered as single ascending doses in Part 1 or once daily for 14 days as multiple ascending doses in Part 2

DRUGPlacebo

Matching placebo capsules administered orally according to the same dosing schedule as ALZ-507


Locations(1)

Quotient Sciences

Miami, Florida, United States

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NCT07824271


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