Safety and Pharmacokinetics of ALZ-507 in Healthy Elderly Adults

NCT07824271 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: ALZ-507-101
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Participants Study

Outcome Measures

Primary Outcomes (1)

• 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).

Secondary Outcomes (9)

• Maximum observed plasma concentration (Cmax) of ALZ-507 following single ascending doses

  Predose through 144 hours (7 days) after administration of a single dose of ALZ-507

• Maximum observed plasma concentration (Cmax) of ALZ-507 under fed and fasted conditions

  Predose through 144 hours (7 days) after administration of a single dose of ALZ-507 under fed and fasted conditions

• Steady-state maximum observed plasma concentration (Cmax,ss) of ALZ-507 after multiple ascending doses

  Predose on Day 1 through 144 hours after the final dose on Day 14 (up to Day 20)

• Amount of ALZ-507 excreted in urine at steady state

  Day 14 through Day 20

• Cerebrospinal Fluid Concentration Following Multiple Doses of ALZ-507

  Approximately 2 hours after dosing on Day 14

Study Arms (2)

Placebo-Controlled

PLACEBO COMPARATOR

Drug: Placebo

Experimental Arm

EXPERIMENTAL

Drug: ALZ-507

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

Experimental Arm

Placebo DRUG

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

Placebo-Controlled

Eligibility Criteria

• Age: 50 Years - 75 Years
• Gender Eligibility Details: Healthy males and females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alzheon Inc.: lead

Study Sites (1)

Quotient Sciences

Miami, Florida, 33126, United States

RECRUITING

Central Study Contacts

John Hey, PhD

CONTACT

508.861.7709; john.hey@alzheon.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 17, 2026
• Study Start: March 9, 2026
• Primary Completion (Estimated): October 28, 2026
• Study Completion (Estimated): November 9, 2026
• Last Updated: September 17, 2026

Record last verified: 2026-09

Locations

US (1)