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| Name | Class |
|---|---|
| Nitto Denko Corporation | INDUSTRY |
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The purpose of this study is to evaluate the safety, tolerability, and the effects two ND-L02-s0201 have on the body
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Module A | Experimental | Lyophilized Formulation |
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| Module B | Experimental | Frozen Formulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ND-L02-s0201 | Drug | Specified dose on specified day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) | Up to 28 days | |
| Time to maximum plasma concentration (Tmax) | Up to 28 days | |
| Area under the plasma concentration-time curve from time 0 to the last available observable concentration (AUC0-t) | Up to 28 days | |
| Area under the plasma concentration-time curve extrapolated to infinity (AUC0-∞) | Up to 28 days | |
| Area under the first moment of the plasma concentration-time curve from time zero to infinity (AUMC0-inf) | Up to 28 days | |
| Apparent first-order terminal elimination rate constant (Kel) | Up to 28 days | |
| Volume of distribution during the elimination phase after IV administration (Vz) | Up to 28 days | |
| Apparent volume of distribution at steady-state (Vss) | Up to 28 days | |
| Total plasma clearance of drug after IV administration (CL/F) | Up to 28 days | |
| Apparent first-order terminal elimination half-life (T1/2) | Up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | Up to 28 days | |
| Incidence of serious adverse events (SAEs) | Up to 28 days | |
| Incidence of discontinuations of study drug due to toxicity |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol inclusion/exclusion criteria may apply
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Up to 28 days |