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

NCT06789861 | Recruiting Phase 1 DMC

• 1 other identifier: P-TT5-PH1-001
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (5)

• Incidence of Adverse Events (AEs) and serious adverse events (SAEs)

  Number of AEs and SAEs:To investigate the safety and tolerability of TT5

  SAD cohorts: Day-1 through Day 8; MAD cohorts: Day-1 through Day 14

• Clinically significant changes in physical examinations

  % 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.

  SAD cohorts: Baseline through Day 8; MAD cohorts: Baseline through Day 14

• Clinically significant changes in vital signs

  % of participants with clinically significant change from baseline in vital signs by measuring heart rate, blood pressure, temperature, and respiratory rate

  SAD cohorts: Day-1 through Day 8; MAD cohorts: Day-1 through Day 14

• Clinically significant changes in laboratory analysis

  Mean and SD of clinically significant changes from baseline in laboratory analysis including hematology, coagulation, biochemistry, and urinalysis

  SAD cohorts: Day-1 through Day 8; MAD cohorts: Day-1 through Day 14

• Bond and Lader Visual Analog Scale (VAS)

  VAS item values: To assess vigilance will using a Visual Analogic Scale namely the Bond-Lader VAS of Mood and Alertness

  SAD cohorts: Day 1 through Day 8; MAD cohorts: Day 1 through Day 14

Secondary Outcomes (13)

• Plasma AUC0-t measurement

  SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8

• Plasma AUC0-inf measurement

  SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8

• Plasma Cmax measurement

  SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8

• Plasma Tmax measurement

  SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8

• Plasma T½ el measurement

  SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8

Other Outcomes (1)

• Biomarkers

  SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8

Study Arms (2)

TT5

EXPERIMENTAL

Drug: TT5

TT5 vehicle

PLACEBO COMPARATOR

Drug: Placebo - TT5 vehicle

Interventions

Placebo - TT5 vehicle DRUG

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

TT5 vehicle

TT5 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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tafalgie Therapeutics: lead

Study Sites (1)

Cmax & PARC

Adelaide, South Australia, 5000, Australia

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Guy Ludbrook, MD

  University of Adelaide and Royal Adelaide Hospital.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivier Blin, M.D., PhD

CONTACT

+33781637056; Olivier.blin@tafalgie.fr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 23, 2025
• Study Start: May 23, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 10, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)