A Randomized, Double Blind, Placebo-controlled, Dose-escalation Phase I Study to Investigate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GX-P1 After Single IV Infusion in Healthy Male Volunteers

Genexine, Inc.1 site in 1 country24 target enrollmentAugust 11, 2020

Overview

This study is a single-center, double-blind, placebo-controlled, phase I study with healthy male volunteers receiving ascending single dose of GX-P1

Registry

clinicaltrials.gov

Start Date

August 11, 2020

End Date

June 7, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Sponsor

Responsible Party

Sponsor

•Capable of understanding and complying with the requirements of the study and have voluntarily signed the informed consent form (ICF)
•Healthy male volunteers aged 19-45 years within screening periods
•Body weight of 50-90 kg, and body mass index (BMI) of 18.0-30.0 kg/m2
•Healthy subjects as determined by medical history, physical examination vital signs, ECG and clinical laboratory testing

•Any clinical significant pancreatic, hepatic, renal, gastrointestinal, cardiovascular, respiratory, hematological, central nervous system disease or other significant diseases which might influence either the safety of the subject or the absorption, metabolism or excretion of the active agent under investigation
•History of or current disease evidence including malignant tumor
•History of allergy/hypersensitivity or ongoing allergy/hypersensitivity to any drug
•Have participated in another clinical trial with investigational drug within 180 days prior to screening period
•Positive for HCV antibody, HBsAg, or HIV antibody at screening period
•Other clinically significant abnormalities which make subject unsuitable for inclusion this study judged by investigator

Intervention: GX-P1 or Placebo (dose level 1)

Intervention: GX-P1 or Placebo (dose level 2)

Intervention: GX-P1 or Placebo (dose level 3)

Safety and tolerability as measured by AEs

Time Frame: up to 8 weeks

Safety and tolerability will be assessed by monitoring AEs and performing physical/clinical examinations

T1/2, Elimination half life of GX-P1(up to 4 weeks)
Change in number of T cells(up to 4 weeks)
AUC(0-inf), Area under the concentration-time curve from time zero extrapolated to infinite time(up to 4 weeks)
Cmax, Maximum observed concentration(up to 4 weeks)
Tmax, Time to maximum observed concentration(up to 4 weeks)
Incidence of Treatment Emergent anti-drug antibody(ADA) formation(up to 8 weeks)