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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06789861
Registration number
NCT06789861
Ethics application status
Date submitted
9/01/2025
Date registered
23/01/2025
Date last updated
3/06/2025
Titles & IDs
Public title
A First in Human Study of TT5 in Single and Multiple Ascending Doses in Healthy Volunteers and Surgical Patients
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Scientific 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
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Secondary ID [1]
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P-TT5-PH1-001
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Universal Trial Number (UTN)
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Trial acronym
TAFA-FIRST
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pain
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - TT5
Treatment: Drugs - Placebo - TT5 vehicle
Experimental: TT5 -
Placebo comparator: TT5 vehicle -
Treatment: Drugs: 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
Treatment: Drugs: Placebo - TT5 vehicle
Intravenous administration of vehicule, according to the same drug regimen than TT5
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of Adverse Events (AEs) and serious adverse events (SAEs)
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Assessment method [1]
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Number of AEs and SAEs:To investigate the safety and tolerability of TT5
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Timepoint [1]
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SAD cohorts: Day-1 through Day 8; MAD cohorts: Day-1 through Day 14
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Primary outcome [2]
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Clinically significant changes in physical examinations
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Assessment method [2]
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% 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.
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Timepoint [2]
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SAD cohorts: Baseline through Day 8; MAD cohorts: Baseline through Day 14
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Primary outcome [3]
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Clinically significant changes in vital signs
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Assessment method [3]
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% of participants with clinically significant change from baseline in vital signs by measuring heart rate, blood pressure, temperature, and respiratory rate
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Timepoint [3]
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SAD cohorts: Day-1 through Day 8; MAD cohorts: Day-1 through Day 14
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Primary outcome [4]
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Clinically significant changes in laboratory analysis
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Assessment method [4]
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Mean and SD of clinically significant changes from baseline in laboratory analysis including hematology, coagulation, biochemistry, and urinalysis
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Timepoint [4]
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SAD cohorts: Day-1 through Day 8; MAD cohorts: Day-1 through Day 14
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Primary outcome [5]
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Bond and Lader Visual Analog Scale (VAS)
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Assessment method [5]
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VAS item values: To assess vigilance will using a Visual Analogic Scale namely the Bond-Lader VAS of Mood and Alertness
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Timepoint [5]
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SAD cohorts: Day 1 through Day 8; MAD cohorts: Day 1 through Day 14
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Secondary outcome [1]
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Plasma AUC0-t measurement
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Assessment method [1]
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Area under the concentration-time curve from time zero until the last observed concentration (AUC0-t) h\*ng/ml
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Timepoint [1]
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SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8
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Secondary outcome [2]
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Plasma AUC0-inf measurement
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Assessment method [2]
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Area under the concentration-time curve from time zero to infinity (AUC0-inf) h\*ng/ml
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Timepoint [2]
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SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8
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Secondary outcome [3]
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Plasma Cmax measurement
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Assessment method [3]
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Maximum concentration measurement in plasma (ng/ml)
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Timepoint [3]
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SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8
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Secondary outcome [4]
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Plasma Tmax measurement
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Assessment method [4]
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Time to maximum observed concentration in plasma (hours)
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Timepoint [4]
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SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8
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Secondary outcome [5]
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Plasma T½ el measurement
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Assessment method [5]
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Terminal elimination half-life (T½ el) in plasma (hours)
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Timepoint [5]
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SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8
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Secondary outcome [6]
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Plasma Kel measurement
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Assessment method [6]
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Terminal elimination rate constant (Kel) in plasma (fraction/h)
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Timepoint [6]
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SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8
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Secondary outcome [7]
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Plasma Cl/F measurement
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Assessment method [7]
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Apparent clearance (Cl/F) in plasma (mL/min)
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Timepoint [7]
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SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8
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Secondary outcome [8]
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Plasma Vz/F measurement
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Assessment method [8]
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Apparent volume of distribution (Vz/F) in plasma (liters)
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Timepoint [8]
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SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8
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Secondary outcome [9]
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Urine CLr measurement
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Assessment method [9]
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Renal clearance measurement in urine (mL/min)
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Timepoint [9]
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SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8
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Secondary outcome [10]
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Urine Aet1-t2 measurement
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Assessment method [10]
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Amount excreted in urine (Aet1-t2) per interval (mL/min)
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Timepoint [10]
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SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8
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Secondary outcome [11]
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Urine Ae0-t measurement
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Assessment method [11]
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Cumulative urinary excretion from time zero to time t (Ae0-t) ( (mL/min)
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Timepoint [11]
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SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8
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Secondary outcome [12]
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Urine Ae%dose measurement
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Assessment method [12]
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% of drug recovered in urine (Ae%dose)
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Timepoint [12]
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SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8
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Secondary outcome [13]
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ARCI
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Assessment method [13]
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Total Score and Sub-scores of Addiction Research Center Inventory questionnaire to investigate subjective effects
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Timepoint [13]
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SAD cohorts: Day 1 through Day 8; MAD cohorts: Day 1 through Day 14
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Eligibility
Key inclusion criteria
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.
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
23/05/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
29/09/2025
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Actual
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Sample size
Target
94
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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Cmax & PARC - Adelaide
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Tafalgie Therapeutics
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT06789861
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Guy Ludbrook, MD
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Address
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University of Adelaide and Royal Adelaide Hospital.
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Olivier Blin, M.D., PhD
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Address
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Country
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Phone
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+33781637056
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Fax
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Email
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Olivier.blin@tafalgie.fr
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06789861
Download to PDF