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

NCT06789861 · tracked via the Priya Life Science Australia tracker

Sponsor

Tafalgie Therapeutics

Phase

Phase 1

Started

2025-05-23

Last updated

2026-03-18

Condition(s) studied

Pain

Investigational drug(s) / intervention(s)

TT5Placebo - TT5 vehicle

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

Placebo - TT5 vehicle: Intravenous administration of vehicule, according to the same drug regimen than TT5

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

55 Years

Healthy volunteers

Accepted

Main inclusion criteria for Parts A and B: * 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. Main exclusion criteria for Parts A and B: * 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.

Primary outcome measure(s)

Incidence of Adverse Events (AEs) and serious adverse events (SAEs) — SAD cohorts: Day-1 through Day 8; MAD cohorts: Day-1 through Day 14
Number of AEs and SAEs:To investigate the safety and tolerability of TT5
Clinically significant changes in physical examinations — SAD cohorts: Baseline through Day 8; MAD cohorts: Baseline through Day 14
% of participants with clinically significant changes from baseline in physical examinations by measuring general appearance, head, eyes, ears, nose, throat (HEENT), neck (including thyroid and nodes), cardiovascular, respiratory, gastrointestinal, renal, neurological, musculoskeletal, and skin.
Clinically significant changes in vital signs — SAD cohorts: Day-1 through Day 8; MAD cohorts: Day-1 through Day 14
% of participants with clinically significant change from baseline in vital signs by measuring heart rate, blood pressure, temperature, and respiratory rate
Clinically significant changes in laboratory analysis — SAD cohorts: Day-1 through Day 8; MAD cohorts: Day-1 through Day 14
Mean and SD of clinically significant changes from baseline in laboratory analysis including hematology, coagulation, biochemistry, and urinalysis
Bond and Lader Visual Analog Scale (VAS) — SAD cohorts: Day 1 through Day 8; MAD cohorts: Day 1 through Day 14
VAS item values: To assess vigilance will using a Visual Analogic Scale namely the Bond-Lader VAS of Mood and Alertness

Trial sites (1)

Facility	City	Region	Status
Cmax & PARC	Adelaide	South Australia	Recruiting

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Single Ascending Doses (SAD) and Multiple Ascending Doses(MAD) Study of IG001119 in Healthy Adult Participants Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06789861 on ClinicalTrials.gov ↗ ← All trials in Australia