Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT05116969
Brief 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
Detailed 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:
NCT05116969
Study Brief:
Protocol Section:
NCT05116969