Not Yet RecruitingPhase 1

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

88 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 range18 Years – 65 Years

SexALL

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.
✓. Participants are required to follow specific contraception measures as follows:
✓. Vital signs within the following ranges:

Exclusion criteria

✕. Any active medical condition determined clinically significant by the Investigator, except for DKD (for DKD participants).
✕. Body mass index (BMI) \> 32 kg/m2 for healthy participants; \> 40 kg/m2 for DKD participants.
✕. Use of any systemic immunosuppressant medications, medications to treat diabetes (except DKD participants), antipsychotics, anticoagulants, or other prescription medications other than contraceptives within 90 days of Screening that, as determined by the Investigator, could confound their participation in the study.
✕. Received a vaccine within 30 days of Screening.
✕. Cancer or a history of cancer or lymphoproliferative disorder within 5 years of Screening except for adequately treated non-melanoma cancers of the skin and cervical carcinoma in situ.
✕. Current infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) as evidenced by a positive hepatitis B surface antigen (HbsAg) test at Screening or a positive HIV test at Screening. For hepatitis C, a positive hepatitis C antibody (antiHCV) test is exclusionary unless the participant has previously been treated for hepatitis C, in which case they would be eligible with a negative HCV ribonucleic (RNA) test.
✕. Currently pregnant, lactating, or planning to conceive or contribute to pregnancy during the trial and up to 65 days (for participants of childbearing potential) or 125 days (for males) after the participant's last dose of study drug, if applicable.
✕. History of severe depression, psychosis, or suicidal ideation, as determined by the Investigator, within 5 years of Screening.

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

Clinically Significant Changes in Electrocardiogram (ECG) Parameters

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 range18 Years – 65 Years

SexALL

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.
✓. Participants are required to follow specific contraception measures as follows:
✓. Vital signs within the following ranges:

Exclusion criteria

✕. Any active medical condition determined clinically significant by the Investigator, except for DKD (for DKD participants).
✕. Body mass index (BMI) \> 32 kg/m2 for healthy participants; \> 40 kg/m2 for DKD participants.
✕. Use of any systemic immunosuppressant medications, medications to treat diabetes (except DKD participants), antipsychotics, anticoagulants, or other prescription medications other than contraceptives within 90 days of Screening that, as determined by the Investigator, could confound their participation in the study.
✕. Received a vaccine within 30 days of Screening.
✕. Cancer or a history of cancer or lymphoproliferative disorder within 5 years of Screening except for adequately treated non-melanoma cancers of the skin and cervical carcinoma in situ.
✕. Current infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) as evidenced by a positive hepatitis B surface antigen (HbsAg) test at Screening or a positive HIV test at Screening. For hepatitis C, a positive hepatitis C antibody (antiHCV) test is exclusionary unless the participant has previously been treated for hepatitis C, in which case they would be eligible with a negative HCV ribonucleic (RNA) test.
✕. Currently pregnant, lactating, or planning to conceive or contribute to pregnancy during the trial and up to 65 days (for participants of childbearing potential) or 125 days (for males) after the participant's last dose of study drug, if applicable.
✕. History of severe depression, psychosis, or suicidal ideation, as determined by the Investigator, within 5 years of Screening.

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

Clinically Significant Changes in Electrocardiogram (ECG) Parameters

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