Actively Recruiting
A Phase 1 Randomized, Double-blind, Dose-Escalating Study to Assess the Safety, Tolerability, and Pharmacokinetics of MTX-439 in Healthy Adults and Adults With Diabetic Kidney Disease
Led by Mediar Therapeutics · Updated on 2026-05-20
88
Participants Needed
1
Research Sites
35 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating MTX-439, a monoclonal antibody, in healthy adults and adults with diabetic kidney disease (DKD) to study its safety, tolerability, and how the body processes the drug. This phase 1 trial includes single and multiple ascending dose parts to understand the drug's effects and appropriate dosing. The study is randomized, double-blind, and placebo-controlled to ensure reliable results. The trial includes single ascending dose (SAD) cohorts with healthy participants receiving intravenous doses of MTX-439 or placebo, starting at a low dose and increasing based on safety and drug exposure. DKD participants will also receive doses after safety is confirmed in healthy volunteers. The multiple ascending dose (MAD) portion involves several doses given on Days 1, 15, and 29, with safety and dose escalation decisions guided by earlier results. Participants will be monitored for safety, drug levels in the blood, and immune response for up to 85 days in the SAD groups and 113 days in the MAD groups. Assessments include physical exams, vital signs, electrocardiograms, lab tests, and antibody detection. Study participation involves multiple visits and close observation to track any side effects and how the drug behaves in the body over time.
CONDITIONS
Brief Title
Evaluation of MTX-439 in Healthy Adults and Adults With Diabetic Kidney Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- All genders aged 18 to 65 years.
- Able to read, understand, and sign informed consent.
- Willing and able to complete all study visits and procedures.
- Use no more than 5 cigarettes or nicotine products per week and abstain during inpatient stays.
- Willing to avoid marijuana or cannabinol products for 30 days before screening until study end.
- Agree not to donate eggs (if applicable) or sperm and blood/plasma donations within specified time frames around dosing.
- Agree to use specified contraception methods during and after the study, based on birth gender and childbearing potential.
- Vital signs within specified ranges (blood pressure, pulse, respiration).
- For DKD participants: well-controlled diabetes with minimal medication adjustments, HbA1c below 9.5%, and eGFR between 30 and 60.
You will not qualify if you...
- Any active significant medical condition except DKD for DKD participants.
- BMI over 32 kg/m2 for healthy participants; over 40 kg/m2 for DKD participants.
- Use of systemic immunosuppressants, diabetes medications (except DKD participants), antipsychotics, anticoagulants, or other conflicting drugs within 90 days before screening.
- Received any vaccine within 30 days before screening.
- History of cancer within 5 years except certain skin and cervical cancers.
- Current infection with hepatitis B, hepatitis C (unless treated), or HIV.
- Pregnant, lactating, or planning pregnancy during and shortly after the study.
- History of severe mental illness or suicidal ideation within 5 years.
- History of anaphylaxis or significant allergies.
- History of substance use disorder within 1 year.
- Positive drug or alcohol screen at screening or admission.
- Blood donation within 28 days prior to screening.
- Significant lab abnormalities or diseases interfering with study participation.
- Any surgical procedure within 12 weeks before screening.
- Known allergy to MTX-439 or its ingredients.
- Participation in another investigational study within 30 days or 5 half-lives of that agent.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 85 days for single-ascending dose cohorts; up to 113 days for multiple-ascending dose cohorts
Participants receive single or multiple intravenous doses of MTX-439 or placebo during planned dosing cohorts to assess safety, tolerability, and pharmacokinetics.
Dosing on Day 1 for single-ascending dose cohorts; dosing on Days 1, 15, and 29 for multiple-ascending dose cohorts with additional follow-up visits
Duration - Up to Day 85 for single-ascending dose cohorts; up to Day 113 for multiple-ascending dose cohorts
Participants are followed for safety assessments, pharmacokinetics, immunogenicity, and monitoring of adverse events after dosing.
Multiple follow-up visits over the post-dosing period
Trial Site Locations
Total: 1 location
1
Doherty Clinical Trials
Melbourne, Victoria, Australia, 3002
Actively Recruiting
Research Team
J
Jeffrey Bornstein, MD
J
Jordan Jara
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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