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

NCT07658638 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2026-07-16

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

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

Sponsors & Collaborators

  • Tes Pharma AU Pty Ltd

    collaborator UNKNOWN

  • Tes Pharma S.r.l.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07658638 on ClinicalTrials.gov