PainPhase 1TAFA-FIRSTNCT06789861
A First in Human Study of TT5 in Single and Multiple Ascending Doses in Healthy Volunteers and Surgical Patients
A Phase 1 study testing TT5 in people with Pain, run by Tafalgie Therapeutics at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- TT5
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteAustralia
- Study dates
- 23 May 2025to 10 Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Cmax & PARC
Adelaide, South Australia, 5000
Natasha Payne, +61 8 7088 7900, cmax@cmax.com.au
About this study
Official 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
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.
Read the 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
- Being tested
- TT5, Placebo - TT5 vehicle
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TT5Drug
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 vehicleDrug
Intravenous administration of vehicule, according to the same drug regimen than TT5
| Study group | Role | What they receive |
|---|---|---|
| TT5 | Experimental | Not described Receives: Drug: TT5 |
| TT5 vehicle | Placebo comparator | Not described Receives: Drug: Placebo - TT5 vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs) and serious adverse events (SAEs)
Number of AEs and SAEs:To investigate the safety and tolerability of TT5
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: SAD cohorts: Day 1 through Day 8; MAD cohorts: Day 1 through Day 14
Secondary outcomes (13)
Plasma AUC0-t measurement
Area under the concentration-time curve from time zero until the last observed concentration (AUC0-t) h*ng/ml
Measured: SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8
Plasma AUC0-inf measurement
Area under the concentration-time curve from time zero to infinity (AUC0-inf) h*ng/ml
Measured: SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8
Plasma Cmax measurement
Maximum concentration measurement in plasma (ng/ml)
Measured: SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8
Plasma Tmax measurement
Time to maximum observed concentration in plasma (hours)
Measured: SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8
Plasma T½ el measurement
Terminal elimination half-life (T½ el) in plasma (hours)
Measured: SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8
Plasma Kel measurement
Terminal elimination rate constant (Kel) in plasma (fraction/h)
Measured: SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8
Plasma Cl/F measurement
Apparent clearance (Cl/F) in plasma (mL/min)
Measured: SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8
Plasma Vz/F measurement
Apparent volume of distribution (Vz/F) in plasma (liters)
Measured: SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8
Urine CLr measurement
Renal clearance measurement in urine (mL/min)
Measured: SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8
Urine Aet1-t2 measurement
Amount excreted in urine (Aet1-t2) per interval (mL/min)
Measured: SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8
Urine Ae0-t measurement
Cumulative urinary excretion from time zero to time t (Ae0-t) ( (mL/min)
Measured: SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8
Urine Ae%dose measurement
% of drug recovered in urine (Ae%dose)
Measured: SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8
ARCI
Total Score and Sub-scores of Addiction Research Center Inventory questionnaire to investigate subjective effects
Measured: SAD cohorts: Day 1 through Day 8; MAD cohorts: Day 1 through Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start23 May 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion10 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tafalgie Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guy Ludbrook, MD, Principal investigator, University of Adelaide and Royal Adelaide Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06789861
- Sponsor's protocol ID
- P-TT5-PH1-001
- Acronym
- TAFA-FIRST
- Status last verified
- Mar 2026
- First submitted
- 9 Jan 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06789861
- Acronym / sponsor ID
- TAFA-FIRST / P-TT5-PH1-001
- Conditions
- Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Tafalgie TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 23 May 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 10 Nov 2026 (estimated)
- First posted
- 23 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TT5 | Experimental | Drug: TT5 |
| TT5 vehicle | Placebo comparator | Drug: Placebo - TT5 vehicle |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TT5Direct 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 | Drug | TT5 |
| Placebo - TT5 vehicleIntravenous administration of vehicule, according to the same drug regimen than TT5 | Drug | TT5 vehicle |
Primary outcome
Incidence of Adverse Events (AEs) and serious adverse events (SAEs)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
13 secondary outcomes
Plasma AUC0-t measurement
Time frame: SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8
Plasma AUC0-inf measurement
Time frame: SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8
Plasma Cmax measurement
Time frame: SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8
Plasma Tmax measurement
Time frame: SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8
Plasma T½ el measurement
Time frame: SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8
Plasma Kel measurement
Time frame: SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8
Plasma Cl/F measurement
Time frame: SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8
Plasma Vz/F measurement
Time frame: SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8
Urine CLr measurement
Time frame: SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8
Urine Aet1-t2 measurement
Time frame: SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8
Urine Ae0-t measurement
Time frame: SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8
Urine Ae%dose measurement
Time frame: SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8
ARCI
Time frame: SAD cohorts: Day 1 through Day 8; MAD cohorts: Day 1 through Day 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guy Ludbrook, MD principal investigator
University of Adelaide and Royal Adelaide Hospital.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TT5 in people with Pain, run by Tafalgie Therapeutics at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olivier Blin, M.D., PhD (+33781637056, Olivier.blin@tafalgie.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (AEs) and serious adverse events (SAEs) (time frame: SAD cohorts: Day-1 through Day 8; MAD cohorts: Day-1 through Day 14). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.