Safety and Tolerability of GX-P1 in Healthy Male Volunteers

• Status: Completed
• Trial end date: 2021-06-07
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Genexine, Inc.

Criteria

Inclusion Criteria:

1. Capable of understanding and complying with the requirements of the study and have voluntarily signed the informed consent form (ICF)

2. Healthy male volunteers aged 19-45 years within screening periods

3. Body weight of 50-90 kg, and body mass index (BMI) of 18.0-30.0 kg/m2

4. Healthy subjects as determined by medical history, physical examination vital signs, ECG and clinical laboratory testing

Exclusion Criteria:

1. 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

2. History of or current disease evidence including malignant tumor

3. History of allergy/hypersensitivity or ongoing allergy/hypersensitivity to any drug

4. Have participated in another clinical trial with investigational drug within 180 days prior to screening period

5. Positive for HCV antibody, HBsAg, or HIV antibody at screening period

6. Other clinically significant abnormalities which make subject unsuitable for inclusion this study judged by investigator