NCT06625710

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: GemVax & Kael · Industry
• Sex: All
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is 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. The study is divided into Part A and Part B. Part A focuses on assessing the safety, tolerability, and pharmacokinetic characteristics following a single subcutaneous (SC) administration of the GV1001. Part B aims to evaluate the safety, tolerability and pharmacokinetic characteristics following multiple administrations of GV1001. The dose escalation between each dosage group and the transition from Part A to Part B will be determined by the Safety Review Committee (SRC), based on the safety and tolerability data obtained from the previous dose and Part A. The Safety Review Committee (SRC) is an independent committee that reviews safety data while maintaining blind. An Extra Cohort to assess the safety, tolerability, and pharmacokinetic characteristics of GV1001 in Caucasians can be implemented sequentially after the safety review by the SRC for the 1.12 mg dose group in Part B has been completed. Screening tests will be conducted within 4 weeks of IP administration to select participants deemed suitable for the clinical trial. In this process, informed consent will be obtained, and a screening number will be assigned to the participants. Part A - Single Dose Participants deemed suitable for Part A will be admitted on Day -1. On Day 1 at 9 AM, after fasting, they will receive a single SC administration of GV1001 or a placebo. Following this, they will complete the scheduled assessments of the safety, tolerability and pharmacokinetic characteristics and be discharged on Day 3. An end-of-study visit will take place on Day 8 as an outpatient appointment. Dose escalation to the next dose group within Part A will be determined by the SRC's review. Part B - Multiple Dose Participants deemed suitable for Part B will be admitted on Day -1. On Day 1 at 9 AM, after fasting, participants will receive a single SC administration of GV1001 or a placebo. Following this, they will complete the scheduled assessments of the safety, tolerability and pharmacokinetic characteristics and be discharged on Day 2. Subsequently, participants will receive subcutaneous administrations of GV1001 or placebo in a fasting state during four outpatient visits. At Day 11, participants will be admitted and will complete the scheduled assessments of the safety, tolerability, pharmacokinetic characteristics and the last administration of GV1001 (Day 12). Participants will be discharged on Day 13, and the end of study visit will take place on Day 42, which is 30 days after the last administration. Dose escalation to the next dose group within Part B will be determined by the SRC's review. The total target number of participants is 56. In Part A, 16 participants will be recruited in two dose groups (2.24 mg and 4.48 mg), while in Part B, 32 participants will be recruited across four dose groups (0.56 mg, 1.12 mg, 2.24 mg, and 4.48 mg). An additional cohort consisting of 8 Caucasian participants is planned, which will be recruited after the completion of the 1.12 mg dose group in Part B. All dose groups will recruit participants at a ratio of 6:2 for the study drug to placebo. All dose escalation between dose groups and from Part A to Part B will be determined by the SRC's review and must be carried out sequentially.

Conditions

• Neuro-Degenerative Disease

Interventions

Type	Name	Description
DRUG	GV1001	Lyophilized peptide from hTERT
DRUG	Placebo	0.9 % Normal Saline

Timeline

• Start date: 2024-10-08
• Primary completion: 2025-08-25
• Completion: 2025-08-25
• First posted: 2024-10-03
• Last updated: 2025-11-19

Locations

1 site across 1 country: South Korea