Clinical Trial

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

Recruiting Phase 1
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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.
Protocol Amendment History 1 change
critical Recruitment opened 2026-07-17
Trial Details
NCT Number NCT07658638
Lead Sponsor Tes Pharma S.r.l.
Collaborators: Tes Pharma AU Pty Ltd
Conditions Healthy Volunteers
Enrollment 68 participants
Start Date 2026-07-08
Primary Completion 2027-03-03 (estimated)
Study Completion 2027-03-03 (estimated)
Updated on ClinicalTrials.gov 2026-07-16