Phase 1 Randomized Study of MTX-439 for Safety and Pharmacokinetics in Healthy Adults and Adults With Diabetic Kidney Disease

What this Trial Is About

Researchers are evaluating the safety, tolerability, and pharmacokinetics of MTX-439, a monoclonal antibody, in healthy adults and adults with diabetic kidney disease DKD. This phase 1, randomized, double-blind, placebo-controlled study includes single ascending dose SAD and multiple ascending dose MAD phases. The study aims to understand how MTX-439 behaves in the body and its potential effects in these populations. The SAD phase involves 5 planned intravenous dosing groups for healthy participants, with doses starting very low and increasing based on safety and drug exposure. Participants are randomly assigned to receive MTX-439 or placebo, with initial sentinel dosing for close monitoring. DKD participants will be enrolled in at least 2 dosing groups after safety is confirmed in healthy volunteers. The MAD phase includes 4 dosing groups of healthy participants receiving doses on Days 1, 15, and 29, with dose escalation depending on earlier results. Participants will be followed for safety, pharmacokinetics, and immune response throughout the study. For SAD groups, participation lasts about 85 days, and for MAD groups, about 113 days. Researchers will monitor adverse events, physical exams, vital signs, ECGs, lab tests, and drug levels in the blood. The study includes detailed assessments of dose-related toxicities and immune reactions to MTX-439.

Evaluation of MTX-439 in Healthy Adults and Adults With Diabetic Kidney Disease