Can a monthly shot replace a daily Alzheimer's pill?
NCT ID NCT07799090
First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time
Summary
This Phase 1 trial enrolls healthy adults aged 19 to 45 to compare how the body absorbs a single 280 mg injection of GB-5001A, a long-acting form of donepezil, versus the standard Aricept 5 mg and 10 mg tablets. Researchers measure drug levels in the blood over time to see if the injection provides similar exposure to the pills. They also track any side effects to confirm the injection is safe. The study does not test the drug in Alzheimer's patients, only healthy volunteers.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- GB-5001A, a long-acting injectable form of donepezil, compared with Aricept (donepezil) tablets
- What this could lead to
- If the injection delivers donepezil as effectively as the daily tablets, it could offer a longer-acting option for Alzheimer's treatment, potentially improving adherence.
- What could go wrong
- This is an early, small study in healthy people, not patients. It only checks how the drug is absorbed and cleared, not whether it works for Alzheimer's. The injection may not match the tablets' effects.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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28 people
The number who actually took part.
- Started
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Aug 2025
- Finished
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Apr 2026
- Lead sponsor
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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
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19 to 45 years
- Sex
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Male participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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: * Able to participate, communicate well with the investigators and willing to provide written informed consent to participate in the study. * Healthy male subjects with absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during the screening and could be considered healthy based on the evaluation. * Aged 19-45 years inclusive. * Non-smokers. * Body mass index within 18.5 to 30.0 kg/m2. * Vital signs (after 10 minutes rest) must be within the range (i.e Systolic blood pressure 100 - 129 mmHg; Diastolic blood pressure 60 - 84 mmHg) * Willing to practice abstention or non-hormonal contraception during the study. Exclusion Criteria: * History of allergy or hypersensitivity or contraindication to Donepezil or other allied drugs. * Any major illness in the past 90 days or clinically significant ongoing chronic medical illness. * Presence of any clinically significant abnormal values during screening e.g. significant abnormality of liver function test (AST, ALT, alkaline phosphatase, total bilirubin, direct bilirubin ≥ 1.5 ULN), renal failure or renal function test (serum creatinine concentration \> 1.4 mg/dL and ureum ≥ 1.5 ULN), etc. * Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV. * Clinically significant hematology abnormalities. * Clinically significant 12-Lead electrocardiogram (12-Lead ECG) abnormalities. * Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism or excretion of the study drug, e.g. gastrointestinal disease including gastric or duodenal ulcers or history of gastric surgery. * Past history of anaphylaxis or angioedema. * History of drug or alcohol abuse within 12 months prior to screening for this study. * Participation in any clinical trial within the past 90 days calculated from the last visit until this study's first dosing day. * History of any bleeding or coagulative disorders. * Presence of difficulty in accessibility of veins in left or right arm. * A donation or significant blood loss within 90 days before this study's first dosing day. * Intake of any prescription drug (especially Donepezil), non prescription drug (including hormonal contraception), food supplements or herbal medicines within 28 days of this study's first dosing day. * History of allergic contact dermatitis. * History of muscle weakness. * History of myasthenia gravis. * History of peptic ulcer or Gastritis. * History of seizure. * History of bronchitis, asthma, or lung infections. * Bradycardia was detected during the screening process. * Difficulty in swallowing capsule or tablet.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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PT Equilab International
Jakarta, South Jakarta, 12430, Indonesia