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

ConditionsHealthy Adult Participants Diabetic Kidney Disease

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-65

SponsorMediar Therapeutics

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)

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

MTX-439
Biological/Vaccine
MTX-439 is a recombinant human immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that binds human-secreted protein SMOC2 with high specificity and high affinity
Placebo
Other intervention
Placebo

Treatment groups

88 Participants

are divided into 2 treatment groups

Group A: MTX-439Experimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Incidence of Dose-Limiting Toxicities (DLTs)

Number and percentage of participants who experience a dose-limiting toxicity (DLT) as defined in the protocol. Unit of Measure: Number of participants; Percentage of participants (%)

Time frame

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)

Number and percentage of participants with at least one treatment-emergent adverse event (TEAE). TEAEs will be summarized by seriousness and maximum severity according to protocol-defined criteria Unit of Measure: Number of participants; Percentage of participants (%)

Time frame

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)

Number and percentage of participants with at least one adverse event considered related to study intervention by the investigator. Unit of Measure: Number of participants; Percentage of participants (%)

Time frame

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

Number and percentage of participants requiring dose interruption, dose reduction, or permanent discontinuation of study intervention due to adverse events. Unit of Measure: Number of participants; Percentage of participants (%)

Time frame

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

Secondary outcomes

Change From Baseline in Total SMOC2 Levels

Change from Baseline in circulating total SMOC2 levels following administration of MTX-439 Unit of Measure: Nanograms per milliliter (ng/mL)

Time frame

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

Change From Baseline in Free SMOC2 Levels

Change from Baseline in circulating free SMOC2 levels following administration of MTX-439. Unit of Measure: Nanograms per milliliter (ng/mL)

Time frame

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

Other outcomes

Change From Baseline in Pro-inflammatory Biomarkers

Change from Baseline in circulating pro-inflammatory biomarkers following administration of MTX-439. Unit of Measure: Nanograms per milliliter (ng/mL)

Time frame

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

Change From Baseline in Fibrosis Biomarkers

Change from Baseline in fibrosis biomarkers, including fragment of PRO-C3, PRO-C6, and collagen VII metabolite (C7M), following administration of MTX-439. Unit of Measure: Nanograms per milliliter (ng/mL)

Time frame

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mediar Therapeutics

Lead sponsor

Source ClinicalTrials.gov

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