Healthy Adult ParticipantsPhase 1NCT07473323
Evaluation of MTX-439 in Healthy Adults and Adults With Diabetic Kidney Disease
A Phase 1 study testing MTX-439 in people with Healthy Adult Participants and Diabetic Kidney Disease, run by Mediar Therapeutics at 1 site in Australia.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants, Diabetic Kidney Disease
- What is being tested?
- MTX-439
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteAustralia
- Study dates
- 19 May 2026to Jan 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- Participants are required to follow specific contraception measures as follows:
- Participants assigned male at birth must use a condom (even if vasectomised) at the time of Screening and for 125 days after the final dose.
- Participants assigned female at birth must be of nonchildbearing potential (defined as either at least 6 months surgically sterilised or at least 1 year postmenopausal and confirmed by follicle-stimulating hormone [FSH] level > 40 U/L) OR, if of childbearing potential (defined as not sterilised via bilateral oophorectomy or hysterectomy; still menstruating; or < 1 year has passed since the last menses, if menopausal), must use a combination of 1 highly effective method of contraception and 1 effective method of contraception. This contraceptive practice should begin at least 28 days before the first dose of study drug, continue during the study, and persist for 65 days after the final dose of study drug, if applicable.
- Male participants agree to ensure that their female partners who are of childbearing potential will use a highly effective method of contraception..
- Vital signs within the following ranges:
- Systolic blood pressure: 90-140 mmHg
- Diastolic blood pressure: < 90 mmHg
- Pulse rate: 55-100 bpm
- Respiration rate: 10-16 respirations per minute
- DKD participants:
- All of the above.
- Well-controlled diabetes requiring minimal dose adjustments of antidiabetic medications in the past 3 months and no adjustments within 30 days of Screening.
- Haemoglobin A1C < 9.5%.
- Estimated glomerular filtration rate (eGFR) between 30 and 60.
Who cannot join
- 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.
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- 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.
- History of anaphylaxis or other significant allergies in the opinion of the Investigator.
- History of substance use disorder as specified in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, within 1 year of Screening.
- Positive screen for drugs of abuse or alcohol at Screening or admission to the CRU (Day -1).
- Donation of blood within 28 days of Screening.
- Any clinically significant disease or laboratory abnormality detected at Screening, including diabetes mellitus, that might interfere with a participant's ability to complete the study, on-study evaluations, or participant safety, including the following:
- Haemoglobin < 115 g/L (female) or < 135 g/L (male); > 160 g/L (female) or > 180 g/L (male)
- Absolute neutrophils < 2.0 × 109/L or > 7.5 × 109/L
- White blood cells < 4.0 × 109/L or > 11.0 × 109/L
- Platelet count < 150 × 109/L or > 450 × 109/L
- Any clinically significant abnormality on any of the Screening ECGs
- Alanine aminotransferase or aspartate aminotransferase greater than 1.2 times the upper limit of normal.
- Any surgical procedure, including planned procedures within 12 weeks of Screening.
- Known allergy to MTX-439 or any of its excipients.
- Participation in another research study of an investigational agent within 30 days of Screening or 5 half-lives of the agent, whichever is longer.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Doherty Clinical Trials
Melbourne, Victoria, 3002
Julia Marshall, MD, +61 03 9970 4200
About this study
Official title: 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
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)
Read the detailed description
This is a randomized, double-blind, placebo-controlled, single-ascending dose (SAD) and multiple-ascending dose (MAD) study to assess the safety, tolerability, and PK of single- and multiple-ascending doses of MTX-439 administered in healthy adults and adults with DKD.
The SAD portion of the study with healthy participants will consist of 5 planned intravenous (IV) dosing cohorts, comprising 8 participants. Dosing will be weight based, and the starting dose will be 100 fold below the top of the safety window. Doses will then be increased, depending on the safety, tolerability and drug exposure levels, in subsequent Cohorts, with increases proceeding in either 2x or 3x increments. . Planned doses may be adjusted in response to the data. Additional participants and/or additional dosing cohorts may be added as needed based on the data. Within each HP cohort, participants will be randomly assigned to receive MTX-439 or matched placebo. The first 2 participants (sentinel participants) within each HP cohort will be randomized 1:1 to receive MTX-439 or placebo on Day 1. These participants will be monitored for 24 hours and, after review of the safety data from both participants and approval by the study Investigator, Medical Monitor, and Sponsor's Responsible Medical Officer (SRMO), the additional 6 participants will be randomized to study drug (n=5 MTX-439; n=1 placebo).
In addition, a minimum of 2 planned IV dosing cohorts comprising 8 DKD participants will receive MTX439 or matched placebo to assess the PK in patients vs healthy controls. DKD Cohort 1 may be dosed any time after the dose escalation meeting for HP Cohort 2 is completed, and the decision is made to dose escalate. The starting dose of study drug in DKD Cohort 1 will be the same as the dose for Cohort 1 in healthy volunteers. No dose can be administered to DKD participants until the same or higher dose has been safely administered to healthy participants. Participants in the DKD SAD portion of the study will be randomized 3:1 to receive MTX-439 or matched placebo on Day 1. Sentinel dosing will not be required in DKD cohorts.
The MAD portion of the study will consist of 4 planned IV dosing cohorts comprising 8 healthy participants (n=6 MTX-439; n=2 placebo).Dosing for each MAD cohort is planned for Day 1, Day 15 and Day 29. Cohort 1 of the MAD portion of the study can begin following completion of the SAD Cohort 2 safety meeting and once the study Investigator, Medical Monitor, and SRMO decide to proceed to HP SAD Cohort 3. Dose escalation will occur depending on the safety, tolerability and PK in previous cohorts.
Participants will be in the study will be followed for safety and be assessed for PK and immunogenicity. For SAD cohorts, participation will be 85 days and for MAD cohorts 113 days.
- Being tested
- MTX-439, Placebo
- Keywords
- MTX-439-K101, MTX-439, Healthy Volunteers, Diabetic Kidney Disease, HV, DKD, Adult, Monoclonal Antibody, SMOC2, SAD, MAD
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTX-439Biological
MTX-439 is a recombinant human immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that binds human-secreted protein SMOC2 with high specificity and high affinity
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| MTX-439 | Experimental | MTX-439 Receives: Biological: MTX-439 |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (%)
Measured: 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 (%)
Measured: 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 (%)
Measured: 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 (%)
Measured: 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
Number and percentage of participants with clinically significant abnormalities in physical examination findings.
Unit of Measure:
Number of participants; Percentage of participants (%)
Measured: Baseline up to Day 85 for SAD cohorts and up to Day 113 for MAD cohorts
Clinically Significant Changes in Vital Signs
Number and percentage of participants with clinically significant changes from baseline in vital signs measurements (including blood pressure, heart rate, respiratory rate, temperature, and pulse oximetry).
Unit of Measure:
Number of participants; Percentage of participants (%)
Measured: Baseline up to Day 85 for SAD cohorts and up to Day 113 for MAD cohorts
Clinically Significant Changes in Electrocardiogram (ECG) Parameters
Number and percentage of participants with clinically significant abnormalities in ECG parameters (including but not limited to PR interval, QRS duration, and QT/QTc interval).
Unit of Measure:
Number of participants; Percentage of participants (%)
Measured: Baseline up to Day 85 for SAD cohorts and up to Day 113 for MAD cohorts
Clinically Significant Changes in Clinical Laboratory Parameters
Number and percentage of participants with clinically significant changes from baseline in hematology, clinical chemistry, urinalysis, and other protocol-specified laboratory parameters.
Unit of Measure:
Number of participants; Percentage of participants (%)
Measured: Baseline up to Day 85 for SAD cohorts and up to Day 113 for MAD cohorts
Maximum Observed Plasma Concentration (Cmax) of MTX-439
Maximum observed plasma concentration (Cmax) of MTX-439 following single and multiple ascending doses.
Unit of Measure:
Nanograms per milliliter (ng/mL)
Measured: From first dose up to Day 85 for SAD cohorts and up to Day 113 for MAD cohorts
Area Under the Plasma Concentration-Time Curve From Time Zero to Time t (AUC0-t) of MTX-439
Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t) of MTX-439.
Unit of Measure:
Nanogram·hour per milliliter (ng·h/mL)
Measured: From first dose up to Day 85 for SAD cohorts and up to Day 113 for MAD cohorts
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of MTX-439
Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of MTX-439.
Unit of Measure:
Nanogram·hour per milliliter (ng·h/mL)
Measured: From first dose up to Day 85 for SAD cohorts and up to Day 113 for MAD cohorts
Area Under the Plasma Concentration-Time Curve Over the Dosing Interval (AUC0-tau) of MTX-439
Area under the plasma concentration-time curve over the dosing interval (AUC0-tau) of MTX-439 at steady state, where applicable
Unit of Measure:
Nanogram·hour per milliliter (ng·h/mL)
Measured: From first dose up to Day 85 for SAD cohorts and up to Day 113 for MAD cohorts
Time to Maximum Plasma Concentration (Tmax) of MTX-439
Time to reach maximum observed plasma concentration (Tmax) of MTX-439 following dosing.
Unit of Measure:
Hours (h)
Measured: From first dose up to Day 85 for SAD cohorts and up to Day 113 for MAD cohorts
Terminal Elimination Half-Life (t1/2) of MTX-439
Terminal elimination half-life (t1/2) of MTX-439 following dosing.
Unit of Measure:
Hours (h)
Measured: From first dose up to Day 85 for SAD cohorts and up to Day 113 for MAD cohorts
Incidence and Characterization of Anti-Drug Antibodies (ADA)
Number and percentage of participants with detectable anti-drug antibodies (ADA), including ADA titer and assessment of the impact of ADA on PK and safety, if applicable.
Unit of Measure:
Number of participants; Percentage of participants (%); Titer (unitless dilution factor)
Measured: From first dose up to Day 85 for SAD cohorts and up to Day 113 for MAD cohorts
Secondary outcomes (2)
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)
Measured: 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)
Measured: Baseline up to Day 85 for SAD cohorts and up to Day 113 for MAD cohorts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start19 May 2026
- Primary completionMay 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mediar Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07473323
- Sponsor's protocol ID
- MTX-439-K101
- Status last verified
- Jun 2026
- First submitted
- 26 Feb 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07473323
- Acronym / sponsor ID
- MTX-439-K101
- Keywords
- MTX-439-K101, MTX-439, Healthy Volunteers, Diabetic Kidney Disease, HV, DKD, Adult, Monoclonal Antibody
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Mediar TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 19 May 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
This is a randomized, double-blind, placebo-controlled, single-ascending dose (SAD) and multiple-ascending dose (MAD) study to assess the safety, tolerability, and PK of single- and multiple-ascending doses of MTX-439 administered in healthy adults and adults with DKD.
The SAD portion of the study with healthy participants will consist of 5 planned intravenous (IV) dosing cohorts, comprising 8 participants. Dosing will be weight based, and the starting dose will be 100 fold below the top of the safety window. Doses will then be increased, depending on the safety, tolerability and drug exposure levels, in subsequent Cohorts, with increases proceeding in either 2x or 3x increments. . Planned doses may be adjusted in response to the data. Additional participants and/or additional dosing cohorts may be added as needed based on the data. Within each HP cohort, participants will be randomly assigned to receive MTX-439 or matched placebo. The first 2 participants (sentinel participants) within each HP cohort will be randomized 1:1 to receive MTX-439 or placebo on Day 1. These participants will be monitored for 24 hours and, after review of the safety data from both participants and approval by the study Investigator, Medical Monitor, and Sponsor's Responsible Medical Officer (SRMO), the additional 6 participants will be randomized to study drug (n=5 MTX-439; n=1 placebo).
In addition, a minimum of 2 planned IV dosing cohorts comprising 8 DKD participants will receive MTX439 or matched placebo to assess the PK in patients vs healthy controls. DKD Cohort 1 may be dosed any time after the dose escalation meeting for HP Cohort 2 is completed, and the decision is made to dose escalate. The starting dose of study drug in DKD Cohort 1 will be the same as the dose for Cohort 1 in healthy volunteers. No dose can be administered to DKD participants until the same or higher dose has been safely administered to healthy participants. Participants in the DKD SAD portion of the study will be randomized 3:1 to receive MTX-439 or matched placebo on Day 1. Sentinel dosing will not be required in DKD cohorts.
The MAD portion of the study will consist of 4 planned IV dosing cohorts comprising 8 healthy participants (n=6 MTX-439; n=2 placebo).Dosing for each MAD cohort is planned for Day 1, Day 15 and Day 29. Cohort 1 of the MAD portion of the study can begin following completion of the SAD Cohort 2 safety meeting and once the study Investigator, Medical Monitor, and SRMO decide to proceed to HP SAD Cohort 3. Dose escalation will occur depending on the safety, tolerability and PK in previous cohorts.
Participants will be in the study will be followed for safety and be assessed for PK and immunogenicity. For SAD cohorts, participation will be 85 days and for MAD cohorts 113 days.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MTX-439 | Experimental | Biological: MTX-439MTX-439 |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MTX-439MTX-439 is a recombinant human immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that binds human-secreted protein SMOC2 with high specificity and high affinity | Biological | MTX-439 |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: From first dose up to Day 85 for SAD cohorts and up to Day 113 for MAD cohorts
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 (%)
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: From first dose up to Day 85 for SAD cohorts and up to Day 113 for MAD cohorts
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 (%)
Incidence of Treatment-Related Adverse Events (TRAEs)
Time frame: From first dose up to Day 85 for SAD cohorts and up to Day 113 for MAD cohorts
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 (%)
Incidence of Dose Modifications Due to Adverse Events
Time frame: From first dose up to Day 85 for SAD cohorts and up to Day 113 for MAD cohorts
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 (%)
Clinically Significant Changes in Physical Examination Findings
Time frame: Baseline up to Day 85 for SAD cohorts and up to Day 113 for MAD cohorts
Number and percentage of participants with clinically significant abnormalities in physical examination findings. Unit of Measure: Number of participants; Percentage of participants (%)
Clinically Significant Changes in Vital Signs
Time frame: Baseline up to Day 85 for SAD cohorts and up to Day 113 for MAD cohorts
Number and percentage of participants with clinically significant changes from baseline in vital signs measurements (including blood pressure, heart rate, respiratory rate, temperature, and pulse oximetry). Unit of Measure: Number of participants; Percentage of participants (%)
Clinically Significant Changes in Electrocardiogram (ECG) Parameters
Time frame: Baseline up to Day 85 for SAD cohorts and up to Day 113 for MAD cohorts
Number and percentage of participants with clinically significant abnormalities in ECG parameters (including but not limited to PR interval, QRS duration, and QT/QTc interval). Unit of Measure: Number of participants; Percentage of participants (%)
Clinically Significant Changes in Clinical Laboratory Parameters
Time frame: Baseline up to Day 85 for SAD cohorts and up to Day 113 for MAD cohorts
Number and percentage of participants with clinically significant changes from baseline in hematology, clinical chemistry, urinalysis, and other protocol-specified laboratory parameters. Unit of Measure: Number of participants; Percentage of participants (%)
Maximum Observed Plasma Concentration (Cmax) of MTX-439
Time frame: From first dose up to Day 85 for SAD cohorts and up to Day 113 for MAD cohorts
Maximum observed plasma concentration (Cmax) of MTX-439 following single and multiple ascending doses. Unit of Measure: Nanograms per milliliter (ng/mL)
Area Under the Plasma Concentration-Time Curve From Time Zero to Time t (AUC0-t) of MTX-439
Time frame: From first dose up to Day 85 for SAD cohorts and up to Day 113 for MAD cohorts
Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t) of MTX-439. Unit of Measure: Nanogram·hour per milliliter (ng·h/mL)
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of MTX-439
Time frame: From first dose up to Day 85 for SAD cohorts and up to Day 113 for MAD cohorts
Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of MTX-439. Unit of Measure: Nanogram·hour per milliliter (ng·h/mL)
Area Under the Plasma Concentration-Time Curve Over the Dosing Interval (AUC0-tau) of MTX-439
Time frame: From first dose up to Day 85 for SAD cohorts and up to Day 113 for MAD cohorts
Area under the plasma concentration-time curve over the dosing interval (AUC0-tau) of MTX-439 at steady state, where applicable Unit of Measure: Nanogram·hour per milliliter (ng·h/mL)
Time to Maximum Plasma Concentration (Tmax) of MTX-439
Time frame: From first dose up to Day 85 for SAD cohorts and up to Day 113 for MAD cohorts
Time to reach maximum observed plasma concentration (Tmax) of MTX-439 following dosing. Unit of Measure: Hours (h)
Terminal Elimination Half-Life (t1/2) of MTX-439
Time frame: From first dose up to Day 85 for SAD cohorts and up to Day 113 for MAD cohorts
Terminal elimination half-life (t1/2) of MTX-439 following dosing. Unit of Measure: Hours (h)
Incidence and Characterization of Anti-Drug Antibodies (ADA)
Time frame: From first dose up to Day 85 for SAD cohorts and up to Day 113 for MAD cohorts
Number and percentage of participants with detectable anti-drug antibodies (ADA), including ADA titer and assessment of the impact of ADA on PK and safety, if applicable. Unit of Measure: Number of participants; Percentage of participants (%); Titer (unitless dilution factor)
2 secondary outcomes
Change From Baseline in Total SMOC2 Levels
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
Time frame: Baseline up to Day 85 for SAD cohorts and up to Day 113 for MAD cohorts
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MTX-439 in people with Healthy Adult Participants and Diabetic Kidney Disease, run by Mediar Therapeutics at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeffrey Bornstein, MD ((617) 936-0960 ext. 803, jeffrey@mediartx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-Limiting Toxicities (DLTs) (time frame: From first dose up to Day 85 for SAD cohorts and up to Day 113 for MAD cohorts). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.