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

Exclusion Criteria

• •1. Any active medical condition determined clinically significant by the Investigator, except for DKD (for DKD participants).
• •2. Body mass index (BMI) \> 32 kg/m2 for healthy participants; \> 40 kg/m2 for DKD participants.
• •3. 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.
• •4. Received a vaccine within 30 days of Screening.
• •5. 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.
• •6. 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.
• •7. 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.
• •8. History of severe depression, psychosis, or suicidal ideation, as determined by the Investigator, within 5 years of Screening.
• •9. History of anaphylaxis or other significant allergies in the opinion of the Investigator.
• •10. History of substance use disorder as specified in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, within 1 year of Screening.
• •11. Positive screen for drugs of abuse or alcohol at Screening or admission to the CRU (Day -1).
• •12. Donation of blood within 28 days of Screening.
• •13. 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.
• •14. Any surgical procedure, including planned procedures within 12 weeks of Screening.
• •15. Known allergy to MTX-439 or any of its excipients.
• •16. Participation in another research study of an investigational agent within 30 days of Screening or 5 half-lives of the agent, whichever is longer.