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Clinical Trial Summary

Safety and PK study in adults weighing more than 120 kg


Clinical Trial Description

The primary objective of this study is to determine the pharmacokinetic (PK) profile of 600 mg oral TPOXX (3 × 200-mg capsules) administered twice daily (BID) for 7 days in adult subjects weighing more than 120 kg to determine if a change in dosing regimen would be needed in these patients.

Secondary:

The secondary objective of this study is to evaluate the safety and tolerability of 600 mg oral TPOXX administered BID for 7 days in healthy adult subjects weighing more than 120 kg. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04392739
Study type Interventional
Source SIGA Technologies
Contact
Status Completed
Phase Phase 4
Start date July 19, 2019
Completion date December 5, 2019

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