NCT06324604

Safety, Pharmacokinetics, and Pharmacodynamics of MTX-101 in Healthy Adults and Patients

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Mozart Therapeutics Australia Pty Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

First in human study to understand the potential side effects of MTX-101, how long MTX-101 lasts in the human body, and how MTX-101 affects specific human immune cells.

Detailed description

A Phase 1, Part A -prospective, randomized, single-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of MTX-101 in healthy adults (HA). Part B - A multi-center, randomized, open-label study to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of MTX-101 in participants with type 1 diabetes (T1D).

Conditions

• Healthy Volunteers
• Type 1 Diabetes

Interventions

Type	Name	Description
DRUG	Placebo	MTX-101
DRUG	MTX-101	MTX-101 (bispecific CD8 Treg modulator)

Timeline

• Start date: 2024-06-13
• Primary completion: 2027-03-31
• Completion: 2027-06-30
• First posted: 2024-03-22
• Last updated: 2026-03-19

Locations

4 sites across 2 countries: Australia, Austria