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New treatment option for Healthy Adult Participants
Official title Evaluation of MTX-439 in Healthy Adults and Adults With Diabetic Kidney Disease
ClinicalTrials.gov ID: NCT07473323
What this study is testing
What is MTX-439?
MTX-439 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for healthy adult participants.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Willing to refrain from marijuana- or cannabinol-containing products for 30 days before Screening and until the last study visit.
You likely can't join if
- 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...
- 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...
- Current infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) as evidenced by a positive hepatitis B surface antigen (HbsAg)...
See the full eligibility 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...
- 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...
- 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]...
- 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.
- 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...
- 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...
- 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...
- 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...
- Haemoglobin \ 160 g/L (female) or \> 180 g/L (male)
- Absolute neutrophils \ 7.5 × 109/L
- White blood cells \ 11.0 × 109/L
- Platelet count \ 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.
The study team makes the final eligibility decision.
Where it's taking place
- Melbourne, Victoria, Australia
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Melbourne, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.