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This is a double-blind, parallel group and placebo-controlled clinical study to assess safety tolerability, pharmacokinetics and pharmacodynamics of Atrosimab in healthy volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATM001 | Experimental | Escalating dose levels of ATM001 administered as single dose in healthy subjects |
|
| ATM001 Placebo | Placebo Comparator | Escalating dose levels of ATM001 Placebo administered as single dose in healthy subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATM001 | Biological | monovalent anti-TNF-receptor 1 antibody format |
|
| Measure | Description | Time Frame |
|---|---|---|
| pharmacokinetic (PK): Area under the analyte concentration-time curve from time 0 and extrapolated to infinite time (AUC 0-∞) | 8 days | |
| PK: Area under the plasma concentration curve from administration until the last quantifiable sampling point (AUC 0-t) | 8 days | |
| PK: Maximum Plasma Concentration [Cmax] | 8 days | |
| PK: Terminal half life (t1/2) | 8 days | |
| PK: Apparent terminal elimination rate constant (λz) | 8 days | |
| PK: Mean residence time (MRT) | 8 days | |
| PK: Clearance (CL) | 8 days | |
| PK: Apparent volume of distribution (Vz) | 8 days | |
| Any adverse event, serious adverse event (SAE) | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristi McLendon, MD | Q-Pharm Pty Limited | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Q-Pharm | Herston | Brisbane | 4006 | Australia |
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| ATM001 Placebo | Biological | ATM001 Placebo |
|