Evaluating GV1001's safety and pharmacokinetics in healthy adults

A Randomized, Double-blind, Placebo Controlled, Dose-escalation Phase 1 Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics After Single and Multiple Administration of GV1001 in Healthy Subjects

This study is testing the safety and how the body processes a new drug called GV1001 in healthy adults to see if it's safe for future use.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (estimated)
• Ages: 19 Years to 50 Years
• Sex: All
• Sponsor: GemVax & Kael (Industry-sponsored)
• Locations: 1 site (Seoul)
• Trial ID: NCT06625710 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety, tolerability, and pharmacokinetic characteristics of GV1001 through both single and multiple administrations in healthy subjects. It is structured in two parts: Part A involves a single dose administration with an 8-day participation period, while Part B includes multiple doses over 42 days with two 3-day hospitalizations. The study employs a randomized, double-blind, placebo-controlled design, with a Safety Review Committee overseeing dose escalation based on safety data. An additional cohort will evaluate the drug's effects specifically in Caucasian participants.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 19 to 50 years, with specific inclusion criteria regarding weight and BMI.

Not a fit: Patients with significant medical histories or conditions that could affect pharmacokinetics will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide critical safety and pharmacokinetic data that may support the development of GV1001 for treating neuro-degenerative diseases.

How similar studies have performed: While this approach is common in early-phase trials, the specific evaluation of GV1001's pharmacokinetics in healthy subjects is a novel application.

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.

Where this trial is running

Seoul

• Seoul National University Hospital — Seoul, Korea, Republic of (Recruiting)

Study contacts

• Principal investigator: Kyung-Sang Yu, M.D., Ph.D. — Seoul National University Hospital
• Study coordinator: Kyung-Sang Yu, M.D., Ph.D.

Conditions Neuro-Degenerative Disease; Pharmacokinetic Characeristics