Evaluation of MTX-439 in Healthy Adults and Adults With Diabetic Kidney Disease
NCT07473323 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 88
Last updated 2026-05-20
Summary
This is a phase 1 randomized, double-blind, single ascending dose (SAD) and multiple ascending dose (MAD) study to assess the safety, tolerability, and Pharmacokinetics (PK) of single and multiple ascending doses of MTX-439 administered in healthy adults and adults with diabetic kidney disease (DKD)
Conditions
- Healthy Adult Participants
- Diabetic Kidney Disease
Interventions
- BIOLOGICAL
-
MTX-439
MTX-439 is a recombinant human immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that binds human-secreted protein SMOC2 with high specificity and high affinity
- OTHER
-
Placebo
Placebo
Sponsors & Collaborators
-
Mediar Therapeutics
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-05-31
- Primary Completion
- 2027-05-31
- Completion
- 2028-01-31
Countries
- Australia
Study Locations
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