Safe, blood-and-fluid study of ALZ-507 in healthy adults 50–75

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of ALZ-507 after single and multiple doses in healthy adults aged 50–75. Participants receive ALZ-507 or placebo in rising dose cohorts, with a portion under fed vs fasted conditions to see if food changes absorption. Researchers collect blood, urine, and cerebrospinal fluid samples and monitor health through exams and labs to understand safety, how the drug is processed, and its distribution. The goal is to inform further development of ALZ-507 for future trials.

Why it matters

Who can join: the full rules

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

Where it's running

• Quotient Sciences
  Miami, Florida, United States Recruiting

Study contacts

• Study coordinator: John Hey, PhD
• Email: john.hey@alzheon.com
• Phone: 508.861.7709

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.