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RECRUITING
NCT07824271
PHASE1

Safety and Pharmacokinetics of ALZ-507 in Healthy Elderly Adults

Sponsor: Alzheon Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

50 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

84

Start Date

2026-03-09

Completion Date

2026-11-09

Last Updated

2026-09-17

Healthy Volunteers

Yes

Interventions

DRUG

ALZ-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

DRUG

Placebo

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

Locations (1)

Quotient Sciences

Miami, Florida, United States