Actively Recruiting
A First in Human Study of TT5 in Single and Multiple Ascending Doses in Healthy Volunteers and Surgical Patients
Led by Tafalgie Therapeutics · Updated on 2026-03-18
94
Participants Needed
1
Research Sites
76 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 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.
You will not qualify if you...
- 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, had surgery, or given blood within 4 weeks prior to screening visit or plans to give blood or sperm within 90 days following the study.
- Pregnant or lactating female participant.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cmax & PARC
Adelaide, South Australia, Australia, 5000
Actively Recruiting
Research Team
O
Olivier Blin, M.D., PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here