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