OPT101 in Type 1 Diabetes Patients

Inclusion Criteria: 1. Able and willing to give informed consent for the trial 2. Male or female aged ≥18 years on the day of signing informed consent 3. Diagnosis of Type 1 diabetes (T1D) within the last 20 years 4. Is medically stable based on physical examination, medical history, laboratoryresults, and vital signs performed at screening 5. Women of childbearing potential must have a negative highly sensitive serum test (beta-human chorionic gonadotropin) at screening and a negative urine pregnancy testat the Visit 1 Day 1 prior to receiving the investigational product. 6. Women must agree to use one of the following methods of birth control for the durationof the clinical trial: systemic hormonal contraceptive (oral, injected, transdermal),intrauterine device, double barrier (e.g., cervical cap or diaphragm with condom orspermicide). Men with female partners must agree to use double barrier contraception,unless their partner is using systemic hormonal contraceptives or has an intrauterinedevice.

Exclusion Criteria:

1. Is over the age of 60 years old
2. Currently has or had a history of malignancy
3. Has an immune deficiency syndrome (for example, severe combined immunodeficiencysyndrome, T-cell deficiency syndromes, B-cell deficiency syndromes, or chronicgranulomatous disease), or bone marrow or organ transplantation, or a diseaseassociated with lymphopenia
4. Is currently receiving an immuno-modulatory treatment.
5. Patients with a history of venous and arterial thromboembolic events including, butnot limited to, the following: deep venous thrombosis, pulmonary embolism, myocardialinfarction, stroke, transient ischemic attack, or arterial insufficiency causingdigital gangrene should be excluded. In addition, patients with recent immobilizationor recent surgery, should be excluded. Patients with a history of abnormalprothrombotic laboratories such as congenital or inherited deficiency of antithrombinIII, protein C, protein S, or confirmed diagnosis of antiphospholipid syndrome shouldalso be excluded.
6. Has active infections, is prone to infections or has chronic, recurrent oropportunistic infectious disease, including but not limited to, Epstein-Barr virus (EBV), cytomegalovirus (CMV) chronic renal infection, chronic chest infection,sinusitis, recurrent urinary tract infection, Pneumocystis carinii, aspergillosis,latent or active granulomatous infection, histoplasmosis, or coccidioidomycosis or anopen, draining, or infected non-healing skin wound or ulcer
7. Has recent or active hepatitis A infection, current/chronic hepatitis B and hepatitisC infection, or HIV infection. Participants with immunity to hepatitis B from previousinfection (defined as negative HBsAg, positive anti-HBc, and positive hepatitis Bsurface antibody [anti-HBs]) or vaccination (defined as negative HBsAg, negativeanti-HBc, and positive anti-HBs) may be eligible to participate.
8. Has a history of latent or active TB
9. Has received a live (attenuated) vaccine within the last 60 days, including patientswho plan to receive live (attenuated) vaccines during the study or within 60 daysafter the final dose of study treatment.
10. Patients with clinically significant abnormal laboratory test values in screeningblood samples. In particular patients with the following should be excluded: i. Patients with abnormal coagulation panel at screening such as abnormal PT or aPTTor fibrinogen ii. Abnormal liver function tests:
11. Liver enzyme abnormalities (except in the case of known Gilbert's syndrome) 2. AST orALT ≥3x ULN and total bilirubin ≥2x ULN 3. AST or ALT ≥5x ULN 4. AST or ALT ≥3x ULN ifassociated with appearance or worsening of rash or hepatitis symptoms iii. Abnormalplatelet counts (<150,000mcL or > 450,000mcL) iv. Abnormal white blood cell counts (<3mL or > 11mL) v. Abnormal eGFR (<50mg/dL or >1.10mg/dL) vi. Abnormal Factor VIII (> 160%) vii.Abnormal D-Dimer (> 500ng/mL FEU) 11. Patients planning to undergo elective procedures orsurgeries at any time after signing the ICF through the follow-up visit.
12. Is pregnant or breastfeeding or expecting to conceive or father children within theprojected duration of the trial, starting with the screening visit through 120 days afterthe last dose of trial treatment.
13. Recent history of bleeding or bleeding disorders or any condition whereby in theopinion of the treating investigator giving anti-coagulation during treatment would becontraindicated.
14. History of hypersensitivity to antihistamines. 15. Weight is over 250lbs. 16. Patientswith active drug or alcohol abuse within 1 year prior to screening 17. Patient isparticipating in a clinical trial of another investigational drug or device, includingpatients who have participated in another study for a duration of 5 half-lives of theinvestigational agent.
15. Patient is a prisoner 19. Investigators could exclude patients with any medicalcondition, including, but not limited to, cardiac, endocrinologic, hematologic, hepatic,immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, renal, or apsychiatric condition that, in the opinion of the Investigator, could compromise theparticipant's ability to participate in this study.