Testing TT5 for pain relief in healthy volunteers and surgical patients

A First in Human, Three-part, Double Blind, Randomized, Placebo-controlled, Single and Multiple Ascending Dose Study to Investigate Safety and Pharmacokinetics of TT5 in Healthy Participants and Surgical Patients

This study is testing a new pain relief treatment called TT5 in healthy volunteers and surgical patients to see how well it works and if it's safe.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 94 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Tafalgie Therapeutics (industry)
• Locations: 1 site (Adelaide, South Australia)
• Trial ID: NCT06789861 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety, tolerability, pharmacokinetics, and pharmacodynamics of TT5 through a three-part, double-blind, randomized, placebo-controlled approach. It includes healthy participants receiving single and multiple ascending doses, as well as surgical patients receiving multiple doses. The study aims to assess how TT5 affects pain and its psychological responses in participants, while also exploring potential biomarkers. The trial is designed to ensure rigorous safety monitoring and data collection throughout the process.

Who should consider this trial

Good fit: Ideal candidates include healthy non-smokers and surgical patients who meet specific health criteria.

Not a fit: Patients with significant medical or psychiatric histories, or those with renal insufficiency, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a new treatment option for managing pain in various patient populations.

How similar studies have performed: While this approach is novel in its specific application, similar studies have shown promise in evaluating new pain management therapies.

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.

Where this trial is running

Adelaide, South Australia

• Cmax & PARC — Adelaide, South Australia, Australia (RECRUITING)

Study contacts

• Principal investigator: Guy Ludbrook, MD — University of Adelaide and Royal Adelaide Hospital.
• Study coordinator: Olivier Blin, M.D., PhD

Conditions: Pain