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 range19 Years ā 50 Years
SexALL
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Inclusion criteria
ā. is healthy adults aged between 19 and 50 years at the time of screening. In Part B, only male participants will be included.
ā. \[Extra Cohort Only\] is healthy Caucasian aged between 19 and 50 years at the time of screening.
ā. weigh between 50 kg and 90 kg and have a body mass index (BMI) of 18.0 to 27.0.
ā. 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
ā. 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.);
ā. has a history of clinically significant hypersensitivity reactions;
ā. who showed the following results during the screening test:
ā. has a history of substance abuse or those who tested positive for illicit drugs in a urine drug screening.
ā. 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;
ā. who have taken barbiturate-inducing or inhibiting drugs within 1 month prior to the planned first administration;
ā. who have participated in another clinical trial or a bioequivalence study within the past 6 months;
ā. 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;