Status:
RECRUITING
A First in Human Study of TT5 in Single and Multiple Ascending Doses in Healthy Volunteers and Surgical Patients
Lead Sponsor:
Tafalgie Therapeutics
Conditions:
Pain
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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, ...
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 wit...
Eligibility 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.
Key Trial Info
Start Date :
May 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 10 2026
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT06789861
Start Date
May 23 2025
End Date
November 10 2026
Last Update
March 18 2026
Active Locations (1)
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1
Cmax & PARC
Adelaide, South Australia, Australia, 5000