Multiple Dose Study to Evaluate the Efficacy, Safety and Pharmacodynamics of REMD-477 in Subjects With Type 1 Diabetes Mellitus

Inclusion Criteria:

- Men and women between the ages of 18 and 65 years old, inclusive, at the time of
screening;

- Females of non-child bearing potential must be ≥1 year post-menopausal (confirmed by a
serum follicle-stimulating hormone (FSH) levels ≥ 40 IU/mL) or documented as being
surgically sterile. Females of child bearing potential must agree to use two methods
of contraception;

- Male subjects must be willing to use clinically acceptable method of contraception
during the entire study;

- Body mass index between 18.5 and 32 kg/m2, inclusive, at screening;

- Diagnosed with Type 1 diabetes, based on clinical history or as defined by the current
American Diabetes Association (ADA) criteria;

- HbA1c < 10 % at screening;

- Fasting C-peptide < 0.2 ng/mL;

- Treatment with a stable insulin regimen for at least 8 weeks before screening with
multiple daily insulin (MDI) injections or continue subcutaneous insulin infusion
(CSII)

- Willing to use continuous CGM system (e.g. DexCom) throughout the study;

- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤ 1.5x upper
limit of normal (ULN) at screening;

- Able to provide written informed consent approved by an Institutional Review Board
(IRB).

Exclusion Criteria:

- History or evidence of clinically-significant disorder or condition that, in the
opinion of the Investigator, would pose a risk to subject safety or interfere with the
study evaluation, procedures, or completion;

- Significant organ system dysfunction (e.g., clinically significant pulmonary or
cardiovascular disease, anemia [Hemoglobin < 10.0 g/dL], known hemoglobinopathies, and
renal dysfunction [eGFR < 60 ml/min]);

- Any severe symptomatic hypoglycemic event associated with a seizure or requiring help
from other people or medical facility in the past 6 months;

- Myocardial infarction, unstable angina, revascularization procedure, or
cerebrovascular accident ≤12 weeks before screening;

- History of New York Heart Association Functional Classification III-IV cardiac
disease;

- Current or recent (within 1 month of screening) use of diabetes medications other than
insulin;

- Use of steroids and/or other prescribed or over-the-counter medications that are known
to affect the outcome measures in this study or known to influence glucose metabolism;

- Smokes > 10 cigarettes/day, and/or is unwilling to abstain from smoking during
admission periods;

- Known sensitivity to mammalian-derived drug preparations, recombinant protein-based
drugs or to humanized or human antibodies;

- History of illicit drug use or alcohol abuse within the last 6 months or a positive
drug urine test result at screening;

- History of pancreatitis, pancreatic neuroendocrine tumors or multiple endocrine
neoplasia (MEN) or family history of MEN;

- History of pheochromocytoma, or family history of familial pheochromocytoma;

- Known or suspected susceptibility to infectious disease (e.g. taking immunosuppressive
agents or has a documented inherited or acquired immunodeficiency);

- Known history of positive for human immunodeficiency virus (HIV) antibodies, hepatitis
B surface antigen (HbsAg), or hepatitis C antibodies (HepC Ab);

- Participation in an investigational drug or device trial within 30 days of screening
or within 5 times the half-life of the investigational agent in the other clinical
study, if known, whichever period is longer;

- Blood donor or blood loss > 500 mL within 30 days of Day 1;

- Women who are pregnant or lactating/breastfeeding;

- Unable or unwilling to follow the study protocol or who are non-compliant with
screening appointments or study visits;

Other inclusion and exclusion criteria may apply.