Safety and Tolerability of GX-P1 in Healthy Male Volunteers

Genexine

Status and phase: Completed; Phase 1

Conditions: Autoimmune Diseases

Treatments: Drug: GX-P1 or Placebo (dose level 3); Drug: GX-P1 or Placebo (dose level 2); Drug: GX-P1 or Placebo (dose level 1)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04298749

GX-P1-001

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 3 patient groups

GX-P1 dose level 1

Experimental group

Description:

GX-P1 dose level 1

Treatment:

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

GX-P1 dose level 2

Experimental group

Description:

GX-P1 dose level 2

Treatment:

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

GX-P1 dose level 3

Experimental group

Description:

GX-P1 dose level 3

Treatment:

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