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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

Titles & IDs
Public title
A First in Human Study of TT5 in Single and Multiple Ascending Doses in Healthy Volunteers and Surgical Patients
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
Secondary ID [1] 0 0
P-TT5-PH1-001
Universal Trial Number (UTN)
Trial acronym
TAFA-FIRST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Adverse Events (AEs) and serious adverse events (SAEs)
Timepoint [1] 0 0
SAD cohorts: Day-1 through Day 8; MAD cohorts: Day-1 through Day 14
Primary outcome [2] 0 0
Clinically significant changes in physical examinations
Timepoint [2] 0 0
SAD cohorts: Baseline through Day 8; MAD cohorts: Baseline through Day 14
Primary outcome [3] 0 0
Clinically significant changes in vital signs
Timepoint [3] 0 0
SAD cohorts: Day-1 through Day 8; MAD cohorts: Day-1 through Day 14
Primary outcome [4] 0 0
Clinically significant changes in laboratory analysis
Timepoint [4] 0 0
SAD cohorts: Day-1 through Day 8; MAD cohorts: Day-1 through Day 14
Primary outcome [5] 0 0
Bond and Lader Visual Analog Scale (VAS)
Timepoint [5] 0 0
SAD cohorts: Day 1 through Day 8; MAD cohorts: Day 1 through Day 14
Secondary outcome [1] 0 0
Plasma AUC0-t measurement
Timepoint [1] 0 0
SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8
Secondary outcome [2] 0 0
Plasma AUC0-inf measurement
Timepoint [2] 0 0
SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8
Secondary outcome [3] 0 0
Plasma Cmax measurement
Timepoint [3] 0 0
SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8
Secondary outcome [4] 0 0
Plasma Tmax measurement
Timepoint [4] 0 0
SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8
Secondary outcome [5] 0 0
Plasma T½ el measurement
Timepoint [5] 0 0
SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8
Secondary outcome [6] 0 0
Plasma Kel measurement
Timepoint [6] 0 0
SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8
Secondary outcome [7] 0 0
Plasma Cl/F measurement
Timepoint [7] 0 0
SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8
Secondary outcome [8] 0 0
Plasma Vz/F measurement
Timepoint [8] 0 0
SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8
Secondary outcome [9] 0 0
Urine CLr measurement
Timepoint [9] 0 0
SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8
Secondary outcome [10] 0 0
Urine Aet1-t2 measurement
Timepoint [10] 0 0
SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8
Secondary outcome [11] 0 0
Urine Ae0-t measurement
Timepoint [11] 0 0
SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8
Secondary outcome [12] 0 0
Urine Ae%dose measurement
Timepoint [12] 0 0
SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8
Secondary outcome [13] 0 0
ARCI
Timepoint [13] 0 0
SAD cohorts: Day 1 through Day 8; MAD cohorts: Day 1 through Day 14

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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
17/02/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/09/2025
Actual
Sample size
Target
94
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Cmax & PARC - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Tafalgie Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Guy Ludbrook, MD
Address 0 0
University of Adelaide and Royal Adelaide Hospital.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Olivier Blin, M.D., PhD
Address 0 0
Country 0 0
Phone 0 0
+33781637056
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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