Evaluation of the Safety, Tolerability and PK Characteristics of GV1001 in Healthy Subjects

Launched by GEMVAX & KAEL · Oct 1, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called GV1001 to see how safe it is and how well the body can handle it. The trial involves healthy adults and aims to find out the effects of different doses of GV1001 on the body. There are two parts to the study: Part A involves a single dose, with participants participating for 8 days and spending 3 days in the hospital. Part B involves multiple doses over 42 days, with 12 days of treatment and 30 days of safety follow-up, including two separate 3-day hospital stays.

To be eligible for this trial, participants must be healthy adults aged 19 to 50 years. For Part B, only male participants who are Caucasian can join. Participants should weigh between 50 kg and 90 kg and have a specific range for body weight related measures. They cannot have any serious medical conditions or recent use of certain medications or substances. The trial is currently recruiting participants, and those who qualify will be closely monitored for safety and how the treatment affects their bodies. It’s important to note that participants will need to avoid alcohol, certain foods, and smoking during the trial.

Gender

ALL

Eligibility criteria

• 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.