drugset / Trial / NCT07658638

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

NCT07658638 ↗

Phase 1 Recruiting 68 enrolled Tes Pharma S.r.l. Tes Pharma AU Pty Ltd · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The goal of this intervention study is to evaluate the safety and tolerability of TESP-0401, and to understand how the body processes TESP-0401, in healthy participants after single and multiple doses. The study aims to answer the following questions: 1. What are the safety, tolerability, and pharmacokinetic characteristics of a single dose of TESP-0401 in healthy participants? 2. What are the safety, tolerability, and pharmacokinetic characteristics of multiple doses of TESP-0401 in healthy participants? This study will be a randomized, placebo controlled study.

Timeline

Start
2026-07-08
Primary completion
2027-03-03
Completion
2027-03-03

Drugs

EvaluationDrugModalityDoseRoute
Subject TESP-0401 Unknown — Intravenous

Indications

No indication recorded.