RecruitingType I Diabetes
Pharmacokinetic and Early Efficacy of OPT101 in Patients With Type 1 Diabetes Mellitus
Eligible age
18–50 yrs
Accepts
All genders
Locations
5 states
Healthy volunteers
No
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About this study
This study will examine the safety of three times weekly SC injections of OPT101 at each of three dose levels over two weeks as well as one year of treatment with SC OPT101 or placebo to match at a single dose level.
Sponsor: Op-T LLC
You may qualify if…
- ✓ 1\. Able and willing and able to give informed consent for the trial (separate consent must be obtained for Parts B or C).
- ✓ 2\. Willing to wear a continuous glucose monitor for the duration of the trial (e.g., Freestyle Libre 3).
- ✓ 3\. Male or female aged ≥18 to 50 years on the day of signing informed consent. 4. Diagnosis of T1DM within the last 20 years for Part A, within 1 to 10 years \[N=15 at \>5 to 10, N=12 at 1 to 5 yrs\] for Part B, within less than or equal to 1 year for Part C.
- ✓ 5\. For Parts B and C only, T-cell phenotype Th40 level greater than or equal to 35% of CD3+ leukocytes (performed at the OPT lab).
- ✓ 6\. Is medically stable based on physical examination, medical history, laboratory results, and vital signs performed at screening.
- ✓ 7\. Women of childbearing potential (WOCBP) must have a negative highly sensitive serum test (beta- human chorionic gonadotropin) at screening and a negative urine pregnancy test at the Visit 1 Day 1 prior to receiving the investigational product.
- ✓ 8\. WOCBP must agree to use one of the following methods of birth control for the duration of the clinical trial: Systemic hormonal contraceptive (oral, injected, transdermal), intrauterine device, double barrier (e.g., cervical cap or diaphragm with condom or spermicide). Men with female partners must agree to use double barrier contraception, unless their partner is using systemic hormonal contraceptives or has an intrauterine device.
You may not qualify if…
- ✕ 1\. Current malignancy or history of malignancy other than basal cell carcinoma or squamous cell carcinoma in situ.
- ✕ 2\. Has an immune deficiency syndrome (for example, severe combined immunodeficiency syndrome, T-cell deficiency syndromes, B-cell deficiency syndromes, or chronic granulomatous disease), or bone marrow or organ transplantation, or a disease associated with lymphopenia.
- ✕ 3\. Has chronic kidney disease of Stage 2 or higher with eGFR of \<90 mL/min/1.73m2.
- ✕ 4\. Is currently receiving an immuno-modulatory treatment. 5. Patients with a history of venous and arterial thromboembolic events including, but not limited to, the following:
- ✕ 1. Deep venous thrombosis, pulmonary embolism, myocardial infarction, stroke, transient ischemic attack, or arterial insufficiency causing digital gangrene.
- ✕ 2. Patients with recent immobilization or recent surgery.
- ✕ 3. Patients with a history of abnormal prothrombotic laboratories such as congenital or inherited deficiency of antithrombin III, protein C, protein S, or confirmed diagnosis of antiphospholipid syndrome.
- ✕ 6\. Has an active infections, is prone to infections or has chronic, recurrent or opportunistic infectious disease, including but not limited to, Epstein-Barr virus, cytomegalovirus, chronic renal infection, chronic chest infection, sinusitis, recurrent urinary tract infection, Pneumocystis carinii pneumonia, aspergillosis, latent or active granulomatous infection, histoplasmosis, or coccidioidomycosis or an open, draining, or infected non-healing skin wound or ulcer.
Where it's recruiting
Source: ClinicalTrials.gov · NCT06964087 · last updated 2026-04-06