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NOT YET RECRUITING
NCT07658638
PHASE1

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

Sponsor: Tes Pharma S.r.l.

View on ClinicalTrials.gov

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.

Official title: A Phase 1 Randomised, Double-blind, Placebo-controlled, Parallel Group, Single Ascending Dose (Part A) and Multiple Ascending Dose (Part B) Study to Assess the Safety, Tolerability and Pharmacokinetics of IV Infusion of TESP-0401 in Healthy Participants

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

68

Start Date

2026-06-16

Completion Date

2027-03-03

Last Updated

2026-07-06

Healthy Volunteers

Yes

Interventions

DRUG

TESP-0401

IV infusion, single administration, over 60 minutes, in a fasted state

DRUG

Placebo

IV infusion of placebo, once, over 60 minutes, in a fasted state

DRUG

TESP-0401

IV infusion, QD for 7 days, over 60 minutes, in a fasted state

DRUG

Placebo

IV infusion of placebo, QD for 7 days, over 60 minutes, in a fasted state

Locations (1)

Novatrials

Charlestown, Suite 301, 99 Pacific Highway,NSW, Australia