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

NCT06789861 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2026-03-18

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Tafalgie Therapeutics

    lead INDUSTRY

Principal Investigators

  • Guy Ludbrook, MD · University of Adelaide and Royal Adelaide Hospital.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-05-23
Primary Completion
2026-10-01
Completion
2026-11-10

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

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 NCT06789861 on ClinicalTrials.gov