RECRUITING Phase 1 ClinicalTrials.gov

Safety and Pharmacokinetics of ALZ-507 in Healthy Elderly Adults

Sponsor: Alzheon Inc. • ClinicalTrials.gov ID: NCT07824271

Registry updated: 2026-09-17

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Description

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.

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

Eligibility criteria

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

Conditions

Healthy Participants Study

Locations

Quotient Sciences — Miami, Florida, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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