Evaluation of Safety, Tolerability, and Body Processing of TESP-0401 by IV Infusion in Healthy Adults

What this Trial Is About

Researchers are evaluating the safety, tolerability, and how the body processes TESP-0401 in healthy adults aged 18 to 65 years. This randomized, placebo-controlled phase 1 study aims to understand the effects of single and multiple doses of TESP-0401 given by intravenous infusion over 60 minutes in a fasted state. The study is sponsored by Tes Pharma S.r.l. and focuses on healthy volunteers. Participants receive either a single intravenous infusion of TESP-0401 or placebo, or daily intravenous infusions for 7 days, both administered over 60 minutes while fasting. The study includes multiple cohorts comparing these dosing regimens and placebo infusions. The treatments are given under controlled conditions, and participants are confined at the Clinical Research Unit during dosing. During the study, participants undergo medical evaluations including physical exams, vital signs, laboratory tests, ECGs, and safety monitoring up to 8 days after the last dose. Researchers measure adverse events, drug concentrations in the blood, and pharmacokinetic parameters such as clearance, half-life, and volume of distribution up to 9 days following dosing. The total duration of participation varies according to dosing schedule and safety assessments.

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of TESP-0401 in Healthy Participants