P2a Open Label Study to Evaluate 2-HPβCD in Subjects With Diabetic Kidney Disease

Inclusion Criteria:

1. Capable of giving and has provided a signed Informed Consent Form (ICF).

2. Male or female age 18 to 75 years inclusive, at the time of signing the informedconsent.

3. Women of childbearing potential (WOCBP) and male subjects who are partners of WOCBPmust agree to use an acceptable form of contraception during the study and for 30days following the last dose of study drug.

4. Clinical diagnosis of type 2 diabetes as per guidelines.

5. Clinical diagnosis of diabetic kidney disease in the opinion of the principalinvestigator, or renal biopsy proven diabetic kidney disease without evidence ofadditional pathologic findings of alternative diagnosis.

6. At screening, based on two 24-hour urine collections, geometric mean of twourinary albumin creatine ratios (UACR) ≥ 400 mg/g and ≤ 3500 mg/g.

7. At screening, eGFR equal or greater than 30 and less than 90 mL/min/1.73 m^2.

8. Body mass index (BMI) ≤ 40.0 kg/m^2.

9. If on diabetes and anti-hypertensive medications:

10. Angiotensin converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) inhibitors dose must be stable for 3 months before screening.

11. Sodium-glucose co-transporter 2 (SGLT2) or GLP-1 receptor agonist orlong-acting insulin dose must be stable for at least 3 months prior toscreening.

12. All other diabetes and anti-hypertensive medications must be at a stable dosefor at least 3 months prior to screening.

13. Hemoglobin A1c (HbA1c) ≤10.0% at screening.

14. Willing to comply with IV administration of the study drug for 12 weeks and allprotocol procedures during the study.

Exclusion Criteria:

1. Has a solitary kidney.

2. Has a positive drug screen.

3. Known kidney disease other than diabetic kidney disease.

4. End stage renal disease (ESRD) (i.e., peritoneal dialysis, hemodialysis, or historyof kidney transplantation).

5. Acute kidney injury or dialysis within the last 3 months before the screening visit.

6. Uncontrolled diabetes as defined by HbA1c >10 at screening.

7. Uncontrolled hypertension with systolic blood pressure (SBP) >140 mmHg or diastolicblood pressure (DBP) >90 mmHg during screening.

8. Unstable cardiovascular disease or history of myocardial infarction or arterialthromboembolic events within 3 months prior to screening or severe or unstableangina, New York Heart Association (NYHA) Class III or IV disease, or a QTc interval >480 msec.

9. Patients on IV medication containing cyclodextrin.

10. Patients on steroids, except for those on low-dose topical steroids (per PIdiscretion) or intranasal or inhaled steroids.

11. Surgery within the past 3 months prior to the first study drug administrationdetermined by the Investigator to be clinically relevant.

12. Known malignancy that is progressing or has required active treatment within thepast 3 years. Any exceptions must be approved by the Medical Monitor. a. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinomaof the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ)that have undergone potentially curative therapy are not excluded.

13. Known history of Human Immunodeficiency Virus (HIV) infection (HIV 1/2 antibodies).

14. Known active Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive)or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected)infection.

15. Diabetic ketosis, ketoacidosis and severe infections within a month or activeinfection requiring systemic therapy.

16. History or current evidence of any condition, therapy, or laboratory abnormalitythat might confound the results of the study, interfere with the participants'participation for the full duration of the study, or is not in the best interest ofthe participants to participate in the opinion of the treating Investigator.

17. Known psychiatric or substance abuse disorders that would interfere with cooperationwith the requirements of the study.

18. Women participants who are pregnant or breastfeeding or expecting to conceivechildren within the projected duration of the study or within 30 days ofparticipation.

19. Aspartate aminotransferase (AST) or alanine transaminase (ALT) >3 upper limit ofnormal (ULN). One repeat test may be allowed within 7 days at the discretion of theInvestigator.

20. Absolute neutrophil count ≤ 1.5 x 109/L at screening.

21. Platelets ≤ 100 x 109/L at screening.

22. Abnormal Hemoglobin (Hgb) (for men, abnormal levels are defined as <11.0 grams perdeciliter (gm/dL) or >17.5 gm/dL. For women, < 10.0 gm/dL or >15.3 gm/dL.)

23. Currently participating or have participated in a study of an investigationalproduct or used an investigational device within 3 months (or > 3 half-lives formAbs with prolonged half-life of greater than 30 days) prior to the first dose ofstudy intervention.

24. Patients on antibody therapeutics.

25. History or presence of alcohol or drug abuse within the 1 year prior to the firststudy drug administration.

26. A known history of otologic disease (e.g., Meniere's, sudden hearing loss,fluctuating hearing loss, vestibular schwannoma).

27. Pure tone air conduction thresholds in either ear at 3 consecutive frequencies > 60dB at: 0.25, 0.5, 1, 2, 3, 4, 6, and 8 kHz.

28. Pure tone bone conduction thresholds > 60 dB in either ear that are 10 dB betterthan air conduction thresholds (i.e., air-bone gap > 10 dB) at all of the followingfrequencies: 0.5, 1, 2, and 4 kHz.

29. Use of non-steroidal anti-inflammatory drugs (NSAIDS) during the study period otherthan chronic low dose of aspirin stable for at least 3 months.

30. History of participation in a stem cell or gene therapy trial.