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

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 TT5s 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 TT5s effects and safety.

A First in Human Study of TT5 in Single and Multiple Ascending Doses in Healthy Volunteers and Surgical Patients