drugset / Trial / NCT06625710

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

NCT06625710

Phase 1 Completed 59 enrolled GemVax & Kael
RandomizedSequentialQuadruple-blindOther

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject TERTOMOTIDE Vaccine 0.56 mg Subcutaneous
Subject TERTOMOTIDE Vaccine 1.12 mg Subcutaneous
Subject TERTOMOTIDE Vaccine 2.24 mg Subcutaneous
Subject TERTOMOTIDE Vaccine 4.48 mg Subcutaneous