RecruitingPhase 1

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

Australia88 participantsStarted 2026-05

Plain-language 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)

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. All genders, ages 18 to 65 years, inclusive.
. Able to read and understand the study and all related materials (including the ICF), and provide a signed, written informed consent.
. Willing and able to complete all protocol-required study visits and procedures.
. Consumption of no more than 5 cigarettes or other cotinine-containing products (including tobacco, nicotine gum, patches, nicotine pouches, and e-cigarettes) per week and agreement to abstain from all such products during inpatient stays.
. Willing to refrain from marijuana- or cannabinol-containing products for 30 days before Screening and until the last study visit.
. Agrees to not donate eggs (if applicable) from the time of the first infusion until 65 days after the final dose, or 125 days after the final dose for sperm (if applicable); additionally agrees to not donate blood from 56 days prior to the time of first infusion until 90 days after the last study visit or platelets/plasma from 14 days prior to the time of first infusion until 90 days after the last study visit.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Dose-Limiting Toxicities (DLTs)

Timeframe: From first dose up to Day 85 for SAD cohorts and up to Day 113 for MAD cohorts

Incidence of Treatment-Emergent Adverse Events (TEAEs)

Timeframe: From first dose up to Day 85 for SAD cohorts and up to Day 113 for MAD cohorts

Incidence of Treatment-Related Adverse Events (TRAEs)

Timeframe: From first dose up to Day 85 for SAD cohorts and up to Day 113 for MAD cohorts

Incidence of Dose Modifications Due to Adverse Events

Timeframe: From first dose up to Day 85 for SAD cohorts and up to Day 113 for MAD cohorts

Clinically Significant Changes in Physical Examination Findings

Timeframe: Baseline up to Day 85 for SAD cohorts and up to Day 113 for MAD cohorts

Clinically Significant Changes in Vital Signs

Timeframe: Baseline up to Day 85 for SAD cohorts and up to Day 113 for MAD cohorts

Trial details

NCT IDNCT07473323

SponsorMediar Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-05

Contact for this trial

Jeffrey Bornstein, MD

(617) 936-0960 jeffrey@mediartx.com

View on ClinicalTrials.gov More Healthy Adult Participants trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. All genders, ages 18 to 65 years, inclusive.
. Able to read and understand the study and all related materials (including the ICF), and provide a signed, written informed consent.
. Willing and able to complete all protocol-required study visits and procedures.
. Consumption of no more than 5 cigarettes or other cotinine-containing products (including tobacco, nicotine gum, patches, nicotine pouches, and e-cigarettes) per week and agreement to abstain from all such products during inpatient stays.
. Willing to refrain from marijuana- or cannabinol-containing products for 30 days before Screening and until the last study visit.
. Agrees to not donate eggs (if applicable) from the time of the first infusion until 65 days after the final dose, or 125 days after the final dose for sperm (if applicable); additionally agrees to not donate blood from 56 days prior to the time of first infusion until 90 days after the last study visit or platelets/plasma from 14 days prior to the time of first infusion until 90 days after the last study visit.

What they're measuring

Incidence of Dose-Limiting Toxicities (DLTs)

Timeframe: From first dose up to Day 85 for SAD cohorts and up to Day 113 for MAD cohorts

Incidence of Treatment-Emergent Adverse Events (TEAEs)

Timeframe: From first dose up to Day 85 for SAD cohorts and up to Day 113 for MAD cohorts

Incidence of Treatment-Related Adverse Events (TRAEs)

Timeframe: From first dose up to Day 85 for SAD cohorts and up to Day 113 for MAD cohorts

Incidence of Dose Modifications Due to Adverse Events

Timeframe: From first dose up to Day 85 for SAD cohorts and up to Day 113 for MAD cohorts

Clinically Significant Changes in Physical Examination Findings

Timeframe: Baseline up to Day 85 for SAD cohorts and up to Day 113 for MAD cohorts

Clinically Significant Changes in Vital Signs

Timeframe: Baseline up to Day 85 for SAD cohorts and up to Day 113 for MAD cohorts

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

Exclusion criteria