Safety and Pharmacokinetics of ALZ-507 in Healthy Elderly Adults

Conditions

• Healthy Participants Study

Eligibility Criteria

Sex

ALL

Age

50 Years - 75 Years

Healthy Volunteers

Accepted

Interventions

• ALZ-507 — DRUG
  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
• Placebo — DRUG
  Matching placebo capsules administered orally according to the same dosing schedule as ALZ-507

Study Details

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.

Key Dates

First listed

Sep 17, 2026

Start date

Mar 9, 2026

Status verified

Sep 2026

Primary completion

Oct 28, 2026

Completion

Nov 9, 2026

Study Design

Enrollment

84 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo-Controlled
• Experimental: Experimental Arm

Primary Outcome Measure

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Following Single Ascending Doses of ALZ-507 [ Time Frame: From first dose through the follow-up visit (up to approximately 31 days in Part 1 and up to approximately 35 days in Part 2). ]

Central Contacts

• John Hey, PhD
  508.861.7709
  [email protected]

Locations (1)

Find similar trials in Miami, FL

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