Diabetic Nephropathy Clinical Trials

• 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:

‣ 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.