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 @ 12:09 PM
Ignite Modification Date:
2025-12-24 @ 12:09 PM
NCT ID:
NCT06789861
Brief Summary:
This study is a First in Human, three-parts, double-blind, randomized, placebo-controlled, single and multiple ascending dose study. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TT5 at different doses in healthy and surgical participants.
Detailed Description:
The study will be divided into three parts:
Part A: Single Ascending Dose - healthy participants cohorts with up to 5 dose levels.
Part B: Multiple Ascending Doses - healthy participants cohorts with up to 3 dose levels.
Part C: Surgical patients cohorts with up to 3 dose levels.
The primary Objective is to investigate the safety and tolerability of TT5 in single and multiple ascending intravenous doses in healthy participants and in surgical patients.
The Secondary Objectives are To investigate the pharmacokinetics (PK) of TT5 after single and multiple ascending intravenous doses in healthy participants and after intravenous doses in surgical patients.
* To investigate the acute and chronic psychological subjective response of the healthy participants and surgical patients to TT5
* To assess the pharmacodynamics (PD) of TT5 after intravenous doses in surgical patients. Exploratory Objectives areto explore potential fluid biomarkers for TT5
Study:
NCT06789861
Study Brief:
Protocol Section:
NCT06789861