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

NCT ID: NCT06789861

Last Updated: 2025-06-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-23
• Study Completion Date: 2025-09-29

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

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

TT5

Group Type: EXPERIMENTAL

TT5

Intervention Type: DRUG

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

TT5 vehicle

Group Type: PLACEBO_COMPARATOR

Placebo - TT5 vehicle

Intervention Type: DRUG

Intravenous administration of vehicule, according to the same drug regimen than TT5

Interventions

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

Intervention Type: DRUG

Placebo - TT5 vehicle

Intravenous administration of vehicule, according to the same drug regimen than TT5

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Non-smoker for the confinement period of the study.
• Medically healthy and without clinically significant abnormalities.
• Negative screen for alcohol and drugs of abuse.
• No history of psychiatric disorders.
• Female participants of non-childbearing potential must be post-menopausal or surgically sterile at least 3 months prior to dosing.
• Sexually active females of childbearing potential and non-sterile males must be willing to use an acceptable contraceptive method throughout the study.
• Able to understand the study procedures and provide signed informed consent to participate in the study in English.

Exclusion Criteria

• History of clinically significant asthma, anaphylaxis, major medical, psychiatric illness or surgery.
• Acute or chronic clinically relevant systemic disease or disorder.
• Renal insufficiency
• History of drug or alcohol consumption abuse.
• Drinking excessive amounts of tea, coffee, chocolate and/or beverage containing caffeine.
• Have used any investigational drug or participated in any clinical trial within 4 weeks prior to screening.
• Unable to refrain from strenuous exercise.
• Participant who has received blood or plasma derivatives, who had a surgery or who has given blood within 4 weeks prior to the screening visit or has planned to give blood or sperm within the 90 days following the study.
• Pregnant or lactating female participant.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tafalgie Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guy Ludbrook, MD

Role: PRINCIPAL_INVESTIGATOR

University of Adelaide and Royal Adelaide Hospital.

Locations

Cmax & PARC

Adelaide, South Australia, Australia

Site Status: RECRUITING

Countries

Australia

Central Contacts

Olivier Blin, M.D., PhD

Role: CONTACT

Olivier.blin@tafalgie.fr

+33781637056

Facility Contacts

Natasha Payne

Role: primary

cmax@cmax.com.au

+61 8 7088 7900

Other Identifiers

P-TT5-PH1-001

Identifier Type: -

Identifier Source: org_study_id