Healthy Participants StudyPhase 1NCT07824271
Safety and Pharmacokinetics of ALZ-507 in Healthy Elderly Adults
A Phase 1 study testing ALZ-507 in people with Healthy Participants Study, run by Alzheon Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants Study
- What is being tested?
- ALZ-507
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2026to 9 Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Quotient Sciences
Miami, Florida, 33126
Laura Gonzalez, 305-644-9903, Laura.Gonzalez@quotientsciences.com
About this study
Official title: A Phase 1, Single-Center, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability and Pharmacokinetics in Plasma, Urine and CSF of Single and Multiple Ascending Doses of ALZ-507 in Healthy Participants
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:
Read more
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.
Read the 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.
- Conditions
- Healthy Participants Study
- Being tested
- ALZ-507, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALZ-507Drug
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
PlaceboDrug
Matching placebo capsules administered orally according to the same dosing schedule as ALZ-507
| Study group | Role | What they receive |
|---|---|---|
| Placebo-Controlled | Placebo comparator | Not described Receives: Drug: Placebo |
| Experimental Arm | Experimental | Not described Receives: Drug: ALZ-507 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Following Single Ascending Doses of ALZ-507
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 14 through Day 20
Cerebrospinal Fluid Concentration Following Multiple Doses of ALZ-507
Measured: Approximately 2 hours after dosing on Day 14
Area under the plasma concentration-time curve (AUC) of ALZ-507 following single ascending doses
Measured: Predose through 144 hours after dosing
Amount of ALZ-507 excreted in urine following single ascending doses
Measured: Predose through 144 hours after dosing
Area under the plasma concentration-time curve (AUC) of ALZ-507 under fed and fasted conditions
Measured: Predose through 144 hours after dosing
Steady-state maximum observed plasma concentration (Cmax,ss) of ALZ-507 after multiple ascending doses
Measured: Day 14 through Day 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start9 Mar 2026
- Primary completion28 Oct 2026 (estimated)
- Study completion9 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Participants StudyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alzheon Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824271
- Sponsor's protocol ID
- ALZ-507-101
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Center, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability and Pharmacokinetics in Plasma, Urine and CSF of Single and Multiple Ascending Doses of ALZ-507 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07824271
- Acronym / sponsor ID
- ALZ-507-101
- Conditions
- Healthy Participants Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Alzheon Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- 28 Oct 2026 (estimated)
- Study completion
- 9 Nov 2026 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo-Controlled | Placebo comparator | Drug: Placebo |
| Experimental Arm | Experimental | Drug: ALZ-507 |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALZ-507Participants 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 | Drug | Experimental Arm |
| PlaceboMatching placebo capsules administered orally according to the same dosing schedule as ALZ-507 | Drug | Placebo-Controlled |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Following Single Ascending Doses of ALZ-507
Time frame: 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).
9 secondary outcomes
Maximum observed plasma concentration (Cmax) of ALZ-507 following single ascending doses
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 14 through Day 20
Cerebrospinal Fluid Concentration Following Multiple Doses of ALZ-507
Time frame: Approximately 2 hours after dosing on Day 14
Area under the plasma concentration-time curve (AUC) of ALZ-507 following single ascending doses
Time frame: Predose through 144 hours after dosing
Amount of ALZ-507 excreted in urine following single ascending doses
Time frame: Predose through 144 hours after dosing
Area under the plasma concentration-time curve (AUC) of ALZ-507 under fed and fasted conditions
Time frame: Predose through 144 hours after dosing
Steady-state maximum observed plasma concentration (Cmax,ss) of ALZ-507 after multiple ascending doses
Time frame: Day 14 through Day 20
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ALZ-507 in people with Healthy Participants Study, run by Alzheon Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John Hey, PhD (508.861.7709 ext. 202, john.hey@alzheon.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Following Single Ascending Doses of ALZ-507 (time frame: 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.