A Study to Asses Pharmacokinetics, Safety, and Tolerability of DM199 in Patients With Diabetes Mellitus and Chronic Kidney Disease

Inclusion Criteria:

- Subject is willing and able to provide informed consent for study participation.

- Subject is ≥ 18 years of age.

- Subject has an established diagnosis of T1D or T2D as determined by medical evaluation
at screen.

- Subjects A1c <9.8%

- Subject is clinically stable with respect to underlying renal impairment and diabetes,
as assessed by the Investigator's medical evaluation.

- Subject has been diagnosed with Stage 3 CKD as defined by eGFR (MDRD) between 30 - <60
or Stage 4 as defined by eGFR <30 (not on dialysis) at screening.

- Subject has a body mass index (BMI) between 18 to 45 kg/m2 (inclusive).

Exclusion Criteria:

- Subject has positive drug test for drugs of abuse and/or positive alcohol breath test
at screening and Day 0.

- Subject is unable or unwilling to comply with protocol requirements, including
assessments, tests, and follow-up visits.

- Subject has a history of significant allergic diathesis such as urticaria, angioedema,
or anaphylaxis.

- Subject has had any live vaccination ≤ 3 months prior to enrollment or will require
vaccination during the study.

- Subject must not be taking an ACEi medication for 5 half-lives prior to study drug
administration and for 5 days post study drug administration.

- Subject is unwilling or unable to limit smoking to ≤ 10 cigarettes per day (or other
products that contain nicotine limited to < 200 mg of nicotine/day) during the study
participation period.

- Subject has a current malignancy or active malignancy ≤ 3 years prior to enrollment
except basal cell or squamous cell carcinoma of the skin or in situ cervical cancer
that has undergone potentially curative therapy and ≥ six months have elapsed since
the procedure.

- Subject has an active infection at the time of enrollment, and/or a history of
clinically significant acute bacterial, viral, or fungal systemic infections that
required systemic treatment in the last four weeks prior to enrollment.

- Subject has known medical history of alpha 1-antitrypsin deficiency (α1-antitrypsin
deficiency).

- Subject has serological evidence of human immunodeficiency virus (HIV), hepatitis B
surface antigen (HBsAg), or anti-hepatitis C virus (Anti-HCV) at screen.

- Subject is pregnant or nursing or is planning a pregnancy during the study period.

- Subject is male or female of childbearing potential, is participating in sexual
activity that could lead to pregnancy and is unable or unwilling to practice medically
effective contraception during the study.

- Subject has received any investigational drug or device within 14 days (or 5 half
lives, whichever is longer) prior to study drug administration on Day 1

- Subject has renal artery stenosis as determine at screen with medical history.

- Subject has hypotension as defined by systolic blood pressure ≤ 90 and diastolic blood
pressure ≤ 60 mmHg.

- Subject has Proteinuria: PCR>2000mg/gm (spot testing).

- Subject does not have adequate venous access for blood sampling.

- Subject has any other medical condition which, in the opinion of the Investigator,
will make participation medically unsafe or interfere with the study results.

- Subject has any other clinically significant abnormalities in laboratory test results
at screening that would, in the opinion of the Investigator, increase the subject's
risk of participation, jeopardize complete participation in the study, or compromise
interpretation of study data.

- Subject has any of the following conditions as determined by ECG or medical record:

- Any significant arrhythmia or conduction abnormality, which, in the opinion of
the Investigators and Medical Monitor, may interfere with the safety of the
subject.

- Subject is taking Cimetidine, St. John's Wort, or any other herbal or probiotic
supplement.