Autoimmune Diseases
Conditions
Brief 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
Interventions
DRUGGX-P1 or Placebo (dose level 1)
GX-P1 dose level 1 or placebo
DRUGGX-P1 or Placebo (dose level 2)
GX-P1 dose level 2 or placebo
DRUGGX-P1 or Placebo (dose level 3)
GX-P1 dose level 3 or placebo
Sponsors
Genexine, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
19 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability as measured by AEs | up to 8 weeks | Safety and tolerability will be assessed by monitoring AEs and performing physical/clinical examinations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tmax, Time to maximum observed concentration | up to 4 weeks | Time to maximum observed concentration |
| T1/2, Elimination half life of GX-P1 | up to 4 weeks | Elimination half life of GX-P1 |
| Cmax, Maximum observed concentration | up to 4 weeks | Maximum observed concentration |
| Change in number of T cells | up to 4 weeks | Change of T cell subsets |
| Incidence of Treatment Emergent anti-drug antibody(ADA) formation | up to 8 weeks | Treatment Emergent anti-drug antibody(ADA) formation |
| AUC(0-inf), Area under the concentration-time curve from time zero extrapolated to infinite time | up to 4 weeks | Area under the concentration-time curve from time zero extrapolated to infinite time |
Countries
South Korea
Outcome results
None listed