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RECRUITING
NCT06789861
PHASE1

A First in Human Study of TT5 in Single and Multiple Ascending Doses in Healthy Volunteers and Surgical Patients

Sponsor: Tafalgie Therapeutics

View on ClinicalTrials.gov

Summary

This study is a First in Human, three-parts, double-blind, randomized, placebo-controlled, single and multiple ascending dose study. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TT5 at different doses in healthy and surgical participants.

Official title: A First in Human, Three-part, Double Blind, Randomized, Placebo-controlled, Single and Multiple Ascending Dose Study to Investigate Safety and Pharmacokinetics of TT5 in Healthy Participants and Surgical Patients

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

94

Start Date

2025-05-23

Completion Date

2026-11-10

Last Updated

2026-03-18

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

TT5

Direct Intravenous administration of TT5 (5 ascending doses in Single Ascending Dose Part and 3 ascending doses administered during 7 days in Multiple Ascending Dose Part in healthy volunteers) Direct Intravenous administration of TT5 in surgical patients (4 doses administered on the same day) in surgical patients

DRUG

Placebo - TT5 vehicle

Intravenous administration of vehicule, according to the same drug regimen than TT5

Locations (1)

Cmax & PARC

Adelaide, South Australia, Australia