Back to resultsSafety and Tolerability of GX-P1 in Healthy Male Volunteers
Primary Purpose
Autoimmune Diseases
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
GX-P1 or Placebo (dose level 1)
GX-P1 or Placebo (dose level 2)
GX-P1 or Placebo (dose level 3)
Sponsored by
About this trial
This is an interventional treatment trial for Autoimmune Diseases
Eligibility Criteria
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
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
GX-P1 dose level 1
GX-P1 dose level 2
GX-P1 dose level 3
Arm Description
GX-P1 dose level 1
GX-P1 dose level 2
GX-P1 dose level 3
Outcomes
Primary Outcome Measures
Safety and tolerability as measured by AEs
Safety and tolerability will be assessed by monitoring AEs and performing physical/clinical examinations
Secondary Outcome Measures
Cmax, Maximum observed concentration
Maximum observed concentration
Tmax, Time to maximum observed concentration
Time to maximum observed concentration
T1/2, Elimination half life of GX-P1
Elimination half life of GX-P1
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
Change in number of T cells
Change of T cell subsets
Incidence of Treatment Emergent anti-drug antibody(ADA) formation
Treatment Emergent anti-drug antibody(ADA) formation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04298749
Brief Title
Safety and Tolerability of GX-P1 in Healthy Male Volunteers
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
August 11, 2020 (Actual)
Primary Completion Date
June 7, 2021 (Actual)
Study Completion Date
June 7, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genexine, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autoimmune Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GX-P1 dose level 1
Arm Type
Experimental
Arm Description
GX-P1 dose level 1
Arm Title
GX-P1 dose level 2
Arm Type
Experimental
Arm Description
GX-P1 dose level 2
Arm Title
GX-P1 dose level 3
Arm Type
Experimental
Arm Description
GX-P1 dose level 3
Intervention Type
Drug
Intervention Name(s)
GX-P1 or Placebo (dose level 1)
Intervention Description
GX-P1 dose level 1 or placebo
Intervention Type
Drug
Intervention Name(s)
GX-P1 or Placebo (dose level 2)
Intervention Description
GX-P1 dose level 2 or placebo
Intervention Type
Drug
Intervention Name(s)
GX-P1 or Placebo (dose level 3)
Intervention Description
GX-P1 dose level 3 or placebo
Primary Outcome Measure Information:
Title
Safety and tolerability as measured by AEs
Description
Safety and tolerability will be assessed by monitoring AEs and performing physical/clinical examinations
Time Frame
up to 8 weeks
Secondary Outcome Measure Information:
Title
Cmax, Maximum observed concentration
Description
Maximum observed concentration
Time Frame
up to 4 weeks
Title
Tmax, Time to maximum observed concentration
Description
Time to maximum observed concentration
Time Frame
up to 4 weeks
Title
T1/2, Elimination half life of GX-P1
Description
Elimination half life of GX-P1
Time Frame
up to 4 weeks
Title
AUC(0-inf), Area under the concentration-time curve from time zero extrapolated to infinite time
Description
Area under the concentration-time curve from time zero extrapolated to infinite time
Time Frame
up to 4 weeks
Title
Change in number of T cells
Description
Change of T cell subsets
Time Frame
up to 4 weeks
Title
Incidence of Treatment Emergent anti-drug antibody(ADA) formation
Description
Treatment Emergent anti-drug antibody(ADA) formation
Time Frame
up to 8 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
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Safety and Tolerability of GX-P1 in Healthy Male Volunteers
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