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Can a new oral drug be safe for the aging brain?

NCT ID NCT07780604

Knowledge-focused Sponsor: Galimedix Therapeutics Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 21, 2026 · Last updated Aug 27, 2026 · Updated 2 times

Summary

This first-in-human trial evaluates the safety and tolerability of an experimental oral drug called GAL-101 salt in healthy adults and elderly volunteers. The study is designed to see how the body absorbs and processes the drug at different doses, including whether food affects its absorption. The goal is to gather essential safety data to support future research into potential treatments for conditions like Alzheimer's disease.

What this could mean

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

Active substance
GAL-101 salt, an experimental oral drug
What this could lead to
If successful, this could establish a safe dose of GAL-101 for future studies, potentially paving the way for treatments targeting conditions like Alzheimer's disease.
What could go wrong
This is an early Phase 1 trial focused on safety, not effectiveness. The drug may cause side effects or fail to show promise in later trials.

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

92 people

The number who actually took part.

Started

Nov 2024

Finished

Dec 2025

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

18 to 85 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.

Key Inclusion Criteria: * Healthy male or female participants, as determined by medical history, physical examination, vital signs, electrocardiogram, and clinical laboratory assessments. * Aged years 18-60 for Parts 1-4 and 65-85 years for Part 5. * Body mass index between 18.5 and 30 kg/m². * Able and willing to provide written informed consent. * Willing to comply with contraception requirements, where applicable. Key Exclusion Criteria: * Clinically significant cardiovascular, hepatic, renal, gastrointestinal, neurological, psychiatric, respiratory, hematological, or metabolic disease. * Clinically significant abnormal laboratory, vital-sign, physical-examination, or electrocardiogram findings. * Known hypersensitivity to GAL-101, related compounds, or formulation components. * Use of prohibited prescription or nonprescription medication within the protocol-specified period. * Positive testing for drugs of abuse, alcohol, or relevant infectious diseases. * History of significant alcohol or substance misuse. * Participation in another clinical study or receipt of another investigational product within the protocol-specified period. * Blood donation or significant blood loss within the protocol-specified period. * Pregnant or breastfeeding. * Any condition that, in the investigator's opinion, could affect participant safety or study-result interpretation.

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As listed by the trial registrant

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

Healthy adult participants

Contacts and locations

Locations

  • FARMOVS

    Bloemfontein, South Africa

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