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Healthy volunteers test new drug for brain disease clues

NCT ID NCT06625710

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

Phase 1

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

Participants

59 people

The number who actually took part.

Started

Oct 2024

Finished

Aug 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

19 to 50 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: 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

More trials for these conditions

Other studies related to the condition(s) this trial covers.