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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GX-P1 dose level 1 | Experimental | GX-P1 dose level 1 |
|
| GX-P1 dose level 2 | Experimental | GX-P1 dose level 2 |
|
| GX-P1 dose level 3 | Experimental | GX-P1 dose level 3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GX-P1 or Placebo (dose level 1) | Drug | GX-P1 dose level 1 or placebo |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | South Korea |
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| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| GX-P1 or Placebo (dose level 2) |
| Drug |
GX-P1 dose level 2 or placebo |
|
| GX-P1 or Placebo (dose level 3) | Drug | GX-P1 dose level 3 or placebo |
|
| 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 |