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Clinical Trial Summary

This is a Phase 1, single ascending dose study designed to investigate TAVO101, administered as an IV infusion in healthy subjects. This study is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TAVO101.


Clinical Trial Description

This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose (SAD), single site study. Six subjects will be enrolled into each of the 7 dosing cohorts. Subjects will be randomized at a ratio of 2:1 to receive TAVO101 or placebo. Two sentinel subjects will be utilized (1 active:1 placebo) in each cohort in a manner designed to maintain the blind. Subjects will be evaluated for safety throughout the study up through day 196. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05298046
Study type Interventional
Source Tavotek Biotherapeutics
Contact
Status Active, not recruiting
Phase Phase 1
Start date May 11, 2022
Completion date May 30, 2024

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