Healthy Participants Study
Conditions
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.
Detailed description
This is a Phase 1, single-center, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of ALZ-507 following single ascending doses (SAD) and multiple ascending doses (MAD) in healthy adult participants aged 50 to 75 years. ALZ-507 is an investigational oral formulation. The study will evaluate the safety profile of ALZ-507 and characterize its pharmacokinetic properties in plasma, urine, and cerebrospinal fluid (CSF). The study consists of two parts: Part 1: Single Ascending Dose (SAD) Part 1 will evaluate the safety, tolerability, and plasma and urine pharmacokinetics of single ascending oral doses of ALZ-507 in healthy participants. Up to 60 participants will be enrolled into sequential dose cohorts and randomized in a 3:1 ratio to receive ALZ-507 or matching placebo. Planned dose levels include 150 mg, 350 mg, 550 mg, 750 mg, and an optional 950 mg dose level. Dose escalation decisions will be based on review of available safety, tolerability, and pharmacokinetic data by a Safety Review Committee (SRC). One cohort will participate in a food-effect evaluation in which the same treatment is administered under both fasted and fed conditions following an adequate washout period. Participants will undergo screening assessments to determine eligibility before admission to the clinical research unit. Following administration of study drug, serial blood and urine samples will be collected to characterize the pharmacokinetics of ALZ-507. Safety evaluations will include monitoring of adverse events, clinical laboratory testing, vital signs, physical examinations, and electrocardiograms (ECGs). Part 2: Multiple Ascending Dose (MAD) Part 2 will evaluate the safety, tolerability, and pharmacokinetics of multiple ascending doses of ALZ-507 administered once daily for 14 days. Approximately 24 participants will be enrolled into two sequential cohorts and randomized in a 3:1 ratio to receive ALZ-507 or matching placebo. Dose levels for Part 2 are planned to be selected based on the safety and pharmacokinetic results from Part 1. Participants will receive study treatment once daily for 14 consecutive days. Pharmacokinetic assessments will be conducted in plasma, cerebrospinal fluid and urine. A single CSF sample will be collected on Day 14 to assess penetration of ALZ-507 into the central nervous system. For participants assigned to placebo, a sham lumbar puncture procedure will be performed to maintain study blinding. Safety Assessments Safety and tolerability will be assessed throughout the study by evaluation of: Adverse events and serious adverse events Clinical laboratory parameters, including hematology, clinical chemistry, and urinalysis Vital signs Physical examinations 12-lead electrocardiograms Pharmacokinetic Assessments Pharmacokinetic analyses will be performed using plasma, urine, and CSF samples collected at predefined time points. Assessments will characterize absorption, distribution, metabolism, and elimination of ALZ-507 following single and multiple dosing. The effect of food on pharmacokinetics will also be evaluated in Part 1. Multiple-dose assessments will evaluate steady-state pharmacokinetics and accumulation following repeated administration. Participants will attend a follow-up visit approximately 10 to 17 days after their last dose for ongoing safety assessment and study completion. The results of this study will provide information regarding the safety, tolerability, pharmacokinetic profile, food effect, and CSF exposure of ALZ-507 and will support dose selection and future clinical development of the investigational product.
Interventions
DRUGALZ-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
DRUGPlacebo
Matching placebo capsules administered orally according to the same dosing schedule as ALZ-507
Sponsors
Alzheon Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Area under the plasma concentration-time curve (AUC) of ALZ-507 following single ascending doses | Predose through 144 hours after dosing |
| Amount of ALZ-507 excreted in urine following single ascending doses | Predose through 144 hours after dosing |
| Area under the plasma concentration-time curve (AUC) of ALZ-507 under fed and fasted conditions | Predose through 144 hours after dosing |
Countries
United States
Contacts
CONTACTJohn Hey, PhD
Outcome results
None listed