MedTrace Logo

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

NCT06625710 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2025-11-19

No results posted yet for this study

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.

Conditions

Interventions

DRUG

GV1001

Lyophilized peptide from hTERT

DRUG

Placebo

0.9 % Normal Saline

Sponsors & Collaborators

  • GemVax & Kael

    lead INDUSTRY

Principal Investigators

  • Kyung-Sang Yu, M.D., Ph.D. · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
19 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-08
Primary Completion
2025-08-25
Completion
2025-08-25

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06625710 on ClinicalTrials.gov