Safety and Pharmacokinetics of ALZ-507 in Healthy Elderly Adults

NCT07824271 · tracked via the Priya Life Science USA tracker

Sponsor

Alzheon Inc

Phase

Phase 1

Started

2026-03-09

Last updated

2026-09-17

Condition(s) studied

Healthy Participants Study

Investigational drug(s) / intervention(s)

ALZ-507Placebo

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

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

Study 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

Sex

ALL

Min age

50 Years

Max age

75 Years

Healthy volunteers

Accepted

Inclusion Criteria: * Healthy males and females aged 50 to 75 years, inclusive * Body mass index 18.0 to 35.0 kg/m2, inclusive, and \>50 kg body weight * No clinically significant values for vital signs (systolic blood pressure \[BP\] 90 to 140 mmHg, diastolic BP 40 to 90 mmHg, and HR 50 to 100 bpm) and no clinically significant ECG readings, as determined by the principal investigator or sub investigator Exclusion Criteria: * Participation in a clinical research study within the previous 30 days or within a period of less than 5 times the drug's half-life * Have previously participated in a trial with ALZ-801 or tramiprosate and received study drug * History of any drug or alcohol abuse in the past 2 years * Creatinine clearance of \<60 mL/min using the Cockcroft-Gault equation at screening * Clinically significant abnormal biochemistry, hematology or urinalysis as judged by the investigator * History of clinically significant cardiovascular, pulmonary, chronic respiratory, renal, hepatic, GI, immunologic, endocrine, neurologic, psychiatric or thromboembolic disease; a history of metabolic disturbances; or any current physical conditions that could interfere with the interpretation of the study results as judged by the investigator

Primary outcome measure(s)

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Following Single Ascending Doses of ALZ-507 — 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).

Trial sites (1)

Facility	City	Region	Status
Quotient Sciences	Miami	Florida	Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07824271 on ClinicalTrials.gov ↗ ← All trials in the USA