Evaluation of the Safety, Tolerability and PK Characteristics of GV1001 in Healthy Subjects (NCT06625710) | Clinical Trial Compass
CompletedPhase 1
Evaluation of the Safety, Tolerability and PK Characteristics of GV1001 in Healthy Subjects
South Korea59 participantsStarted 2024-10-08
Plain-language summary
The goal of this clinical trial is to assess the the safety, tolerability and pharmacokinetic characteristics after single and multiple administration of GV1001 in healthy subjects. The main questions it aims to answer are:
Safety and Tolerability of GV1001 in different dose scheme, and PK Characteristics of GV1001 in differenct dose scheme
Part A: single dose, 8 days clinical trial participation including one 3-day hospitalization
Part B \& Extra Cohort: Multiple dose, 42 days clinical trial participation (12 days treatment + 30 days safety follow-up) including two times of 3-day hospitalization.
Who can participate
Age range
19 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. is healthy adults aged between 19 and 50 years at the time of screening. In Part B, only male participants will be included.
. \[Extra Cohort Only\] is healthy Caucasian aged between 19 and 50 years at the time of screening.
. weigh between 50 kg and 90 kg and have a body mass index (BMI) of 18.0 to 27.0.
. 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
. 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.);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. has a history of clinically significant hypersensitivity reactions;
. who showed the following results during the screening test:
. has a history of substance abuse or those who tested positive for illicit drugs in a urine drug screening.
. 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;
. who have taken barbiturate-inducing or inhibiting drugs within 1 month prior to the planned first administration;
. who have participated in another clinical trial or a bioequivalence study within the past 6 months;
. 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;