A Phase 1 Study of PTX-35 in Healthy Volunteers

Status Withdrawn

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

Healthy Volunteer

Clinical Trial Details

NCT number	NCT05116969
Study type	Interventional
Source	Heat Biologics
Contact
Status	Withdrawn
Phase	Phase 1
Start date	November 24, 2021
Completion date	November 29, 2022

View Details

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