NCT06789861

A First in Human Study of TT5 in Single and Multiple Ascending Doses in Healthy Volunteers and Surgical Patients

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 94 (estimated)
• Sponsor: Tafalgie Therapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	TT5	Direct Intravenous administration of TT5 (5 ascending doses in Single Ascending Dose Part and 3 ascending doses administered during 7 days in Multiple Ascending Dose Part in healthy volunteers) Direct Intravenous administration of TT5 in surgical patients (4 doses administered on the same day) in surgical patients
DRUG	Placebo - TT5 vehicle	Intravenous administration of vehicule, according to the same drug regimen than TT5

Timeline

• Start date: 2025-05-23
• Primary completion: 2026-10-01
• Completion: 2026-11-10
• First posted: 2025-01-23
• Last updated: 2026-03-18

Locations

1 site across 1 country: Australia