Actively Recruiting
A First in Human, Three-part, Double Blind, Randomized, Placebo-controlled Study to Investigate Safety and Pharmacokinetics of TT5 in Healthy Volunteers and Surgical Patients
Led by Tafalgie Therapeutics · Updated on 2026-03-18
94
Participants Needed
1
Research Sites
5 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a first-in-human, randomized, placebo-controlled study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TT5 given at different doses in healthy volunteers and surgical patients. This phase 1 trial includes both single and multiple ascending dose parts and involves healthy and surgical participants aged 18 to 55 years. The study aims to explore TT5's effects, including psychological responses and potential fluid biomarkers. The study consists of three parts: Part A tests single ascending intravenous doses of TT5 in healthy participants across up to five dose levels; Part B evaluates multiple ascending doses over seven days in healthy participants with up to three dose levels; and Part C administers intravenous doses on the same day to surgical patients in up to three dose levels. Both TT5 and placebo (vehicle) are given intravenously, and dosing schedules vary according to the study part. Participants will be monitored for adverse events, vital signs, physical exams, laboratory tests, and psychological responses using tools like the Bond and Lader Visual Analog Scale. Pharmacokinetic measurements will include plasma and urine analysis over specified days. Safety and tolerability will be assessed through day 8 for single doses and day 14 for multiple doses. The total study duration varies by cohort, with close follow-up during and after dosing to evaluate TT5's effects and safety.
CONDITIONS
Brief Title
A First in Human Study of TT5 in Single and Multiple Ascending Doses in Healthy Volunteers and Surgical Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Non-smoker during the study confinement period
- Medically healthy without clinically significant abnormalities
- Negative screening for alcohol and drug abuse
- No history of psychiatric disorders
- Female participants of non-childbearing potential must be post-menopausal or surgically sterile for at least 3 months prior to dosing
- Sexually active females of childbearing potential and non-sterile males must agree to use acceptable contraception throughout the study
- Able to understand study procedures and provide signed informed consent in English
You will not qualify if you...
- History of significant asthma, anaphylaxis, major medical or psychiatric illness, or surgery
- Acute or chronic clinically relevant systemic disease or disorder
- Renal insufficiency
- History of drug or alcohol abuse
- Excessive intake of tea, coffee, chocolate, or caffeine-containing beverages
- Use of investigational drugs or participation in clinical trials within 4 weeks prior to screening
- Unable to avoid strenuous exercise
- Blood or plasma donation, surgery, or planned blood/sperm donation within specified timeframes around the study
- Pregnant or breastfeeding females
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 14 days depending on cohort
Participants receive single or multiple intravenous doses of TT5 or placebo. Healthy volunteers participate in single ascending dose cohorts or multiple ascending dose cohorts over several days. Surgical patients receive multiple doses on the same day.
1 to 7 consecutive dosing days depending on cohort
Duration - Up to 6 days after last dose
Participants are monitored for safety and pharmacokinetics after dosing to assess adverse events and clinical changes.
Daily visits for up to 7 days post dosing
Trial Site Locations
Total: 1 location
1
Cmax & PARC
Adelaide, South Australia, Australia, 5000
Actively Recruiting
Research Team
O
Olivier Blin, M.D., PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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