MTX-439 for Diabetic Kidney Disease and Healthy Adults

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

Recruiting Phase 1 Interventional Study
Healthy Adult Participants Diabetic Kidney Disease
Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Other
Participants needed
88 (estimated)
Sponsor
Mediar Therapeutics · Industry
Who this trial is looking for

This trial is looking for healthy adults and adults with diabetic kidney disease to test the safety of a new treatment called MTX-439. Participants will take either single or multiple doses of the treatment and attend several study visits.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am between 18 and 65 years old.
  • I can read and understand the study paperwork and give my written consent.
  • I am willing to complete all study visits.
  • I smoke no more than 5 cigarettes or related products per week.
  • I have well-controlled diabetes with minimal medication adjustments.
  • My haemoglobin A1C is less than 9.5%.
  • My estimated kidney function (eGFR) is between 30 and 60.

You may not be able to join if

  • I have a current medical condition that is significant.
  • My body mass index (BMI) is over 32 if I am healthy, or over 40 if I have diabetic kidney disease.
  • I have used any immunosuppressant medications or drugs to treat diabetes recently.
  • I received a vaccine within the last 30 days.
  • I have cancer or a history of cancer within the last 5 years, except for certain treated skin cancers.
  • I am currently pregnant, breastfeeding, or planning to become pregnant.
  • I have a history of severe depression or psychosis within the last 5 years.
  • I have a known allergy to MTX-439.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

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About This Trial

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)

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. All genders, ages 18 to 65 years, inclusive. 2. Able to read and understand the study and all related materials (including the ICF), and provide a signed, written informed consent. 3. Willing and able to complete all protocol-required study visits and procedures. 4. Consumpti…
Contacts

Jeffrey Bornstein, MD

(617) 936-0960

jeffrey@mediartx.com

CONTACT

Jordan Jara

617-936-0960

jordan.jara@mediartx.com

CONTACT