A First in Human Study of TT5 in Single and Multiple Ascending Doses in Healthy Volunteers 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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE1
Study ID
NCT06789861
Intervention or treatment
DRUG: TT5
DRUG: Placebo - TT5 vehicle
Conditions
- Pain
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
Cmax & PARC
Select from list below to view details:
Cmax & PARC
Adelaide, South Australia, Australia
Loading map...
Who is running the clinical trial?
Tafalgie Therapeutics
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: TT5
| Drug: TT5 |
PLACEBO_COMPARATOR: TT5 vehicle
| Drug: Placebo - TT5 vehicle |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| 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 Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Plasma AUC0-t measurement | Area under the concentration-time curve from time zero until the last observed concentration (AUC0-t) h\*ng/ml | 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 | SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8 |
| Plasma Cmax measurement | Maximum concentration measurement in plasma (ng/ml) | 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) | 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) | 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) | 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) | 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) | SAD cohorts: Day 1 through Day 2; MAD cohorts: Day 1 through Day 8 |
| Urine CLr measurement | Renal clearance measurement in urine (mL/min) | 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) | 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) | 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) | 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 | SAD cohorts: Day 1 through Day 8; MAD cohorts: Day 1 through Day 14 |
References
Clinical Trials Gov: A First in Human Study of TT5 in Single and Multiple Ascending Doses in Healthy Volunteers and Surgical PatientsOther trials to consider
Loading suggested trials...
