Healthy volunteers test new drug for brain disease clues
NCT ID NCT06625710
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tested the safety of a drug called GV1001 in 59 healthy adults. Participants received either a single dose or multiple doses of the drug or a placebo. The goal was to see if the drug is safe and how the body processes it, not to treat any disease. Results will help plan future studies for neurodegenerative conditions like Alzheimer's.
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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59 people
The number who actually took part.
- Started
-
Oct 2024
- Finished
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Aug 2025
- 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
-
19 to 50 years
- Sex
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Anyone
- 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: 1. is healthy adults aged between 19 and 50 years at the time of screening. In Part B, only male participants will be included. 2. \[Extra Cohort Only\] is healthy Caucasian aged between 19 and 50 years at the time of screening. 3. weigh between 50 kg and 90 kg and have a body mass index (BMI) of 18.0 to 27.0. 4. has no skin diseases or skin damage (including scars and tattoos) at the administration site and should not have any medical history that could affect pharmacokinetics (PK) Exclusion Criteria: 1. has clinically significant or history of liver, kidney, nervous system, respiratory system, endocrine, blood, tumor, cardiovascular, or mental disorders (such as mood disorders, obsessive-compulsive disorder, etc.); 2. has a history of clinically significant hypersensitivity reactions; 3. who showed the following results during the screening test: * positive serum test results (Hepatitis B, C test, Human Immunodeficiency Virus (HIV), Syphilis test); * \[Part B only\] testosterone levels outside the normal range (2.67-10.12 ng/ml); * \[Part B only\] Leutinizing hormone (LH) outside the normal range (1.0 - 5.3 mlU/ml); \[Part B only\] Follicular stimulating hormone (FSH) outside the normal range (1.3 - 8.1 mlU/ml) 4. has a history of substance abuse or those who tested positive for illicit drugs in a urine drug screening. 5. who have taken any prescription medications within 2 weeks prior to the planned first administration, or any over-the-counter (OTC) medications or health supplements within 1 week; 6. who have taken barbiturate-inducing or inhibiting drugs within 1 month prior to the planned first administration; 7. who have participated in another clinical trial or a bioequivalence study within the past 6 months; 8. who have donated whole blood within the past 2 months, or have donated blood components within the past month, or have received a transfusion within the past month prior to planned first administration; 9. who engage in continuous alcohol consumption (over 21 units/week = 10g of pure alcohol) or are unable to abstain from alcohol from 3 days prior to the expected first dosing until the last visit. 10. who are unable to abstain from consuming grapefruit-containing foods or caffeine-containing foods from 3 days prior to the planned first administration of the investigational product (IP) until the post study visit (PSV); 11. who have smoked more than 10 cigarettes per day in the past 3 months, or who cannot abstain from smoking during the clinical trial; 12. who do not use medically acceptable methods of contraception during the clinical trial period; 13. pregnant or breastfeeding women.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Seoul National University Hospital
Seoul, South Korea
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Other studies related to the condition(s) this trial covers.
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