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Can a new oral drug reach the brain safely? first human test of ALZ-507

NCT ID NCT07824271

Knowledge-focused Sponsor: Alzheon Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

Researchers are testing an experimental oral drug called ALZ-507 in healthy adults aged 50 to 75. The study checks whether the drug is safe, what side effects it may cause, and how the body absorbs and clears it. Participants receive either ALZ-507 or a placebo, with some getting a single dose and others taking daily doses for two weeks. Blood, urine, and spinal fluid samples help researchers measure how much drug reaches the body and the brain.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an experimental oral drug called ALZ-507
What this could lead to
If ALZ-507 proves safe and reaches the brain, it could become a candidate for treating Alzheimer's disease and other brain conditions.
What could go wrong
This is a first-in-human study in healthy volunteers, so it cannot show whether the drug works. Many drugs that pass phase 1 later fail in larger trials, and unknown side effects may appear.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 84 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy participants study

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Quotient Sciences

    RECRUITING

    Miami, Florida, 33126, United States

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