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Clinical Trial Summary

A Phase 1, Single Dose-Escalation and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous PTX-35 Adminsitration in Healthy Volunteers


Clinical Trial Description

This is a double blind, placebo controlled, Phase 1 study of PTX-35 administered via IV infusion to healthy male and female participants. This study will be conducted in 2 stages: - Stage 1 is a single ascending dose (SAD) escalation period in which 5 dose levels of PTX-35 will be evaluated. - Stage 2 is a multiple dose period in which the highest tolerated dose determined from Stage 1 will be tested in 2 different treatment regimens in 2 cohorts (i.e., 7- and 14- days dosing regimen). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05116969
Study type Interventional
Source Heat Biologics
Contact
Status Not yet recruiting
Phase Phase 1
Start date November 24, 2021
Completion date November 29, 2022

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