Safety and Tolerability of GX-P1 in Healthy Male Volunteers

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

Official Title
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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

Conditions
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Autoimmune Diseases

Intervention / Treatment
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* Drug: GX-P1 or Placebo (dose level 1)
* Drug: GX-P1 or Placebo (dose level 2)
* Drug: GX-P1 or Placebo (dose level 3)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GX-P1 dose level 1<br>GX-P1 dose level 1 | Drug: GX-P1 or Placebo (dose level 1)<br>* GX-P1 dose level 1 or placebo<br>|
| Experimental: GX-P1 dose level 2<br>GX-P1 dose level 2 | Drug: GX-P1 or Placebo (dose level 2)<br>* GX-P1 dose level 2 or placebo<br>|
| Experimental: GX-P1 dose level 3<br>GX-P1 dose level 3 | Drug: GX-P1 or Placebo (dose level 3)<br>* GX-P1 dose level 3 or placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability as measured by AEs | Safety and tolerability will be assessed by monitoring AEs and performing physical/clinical examinations | up to 8 weeks | 

Secondary Outcome Measures

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