Ignite Creation Date:
2025-12-24 @ 12:09 PM
Ignite Modification Date:
2025-12-27 @ 9:21 PM
Study NCT ID:
NCT06789861
Status:
RECRUITING
Last Update Posted:
2025-06-03
First Post:
2025-01-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A First in Human Study of TT5 in Single and Multiple Ascending Doses in Healthy Volunteers and Surgical Patients
Sponsor:
Tafalgie Therapeutics
Organization:
Study Overview
Official Title:
A First in Human, Three-part, Double Blind, Randomized, Placebo-controlled, Single and Multiple Ascending Dose Study to Investigate Safety and Pharmacokinetics of TT5 in Healthy Participants and Surgical Patients
Status:
RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TAFA-FIRST
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: