Actively Recruiting
Pharmacokinetic and Early Efficacy of OPT101 in Patients With Type 1 Diabetes Mellitus
Led by Op-T LLC · Updated on 2026-04-06
72
Participants Needed
5
Research Sites
123 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pharmacokinetic and Early Efficacy of OPT101 in Patients With Type 1 Diabetes Mellitus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to give informed consent for the trial (separate consent for Parts B or C)
- Willing to wear a continuous glucose monitor for the entire trial
- Male or female aged 18 to 50 years at consent
- Diagnosis of type 1 diabetes mellitus within 20 years for Part A; within 1 to 10 years for Part B; within 1 year for Part C
- For Parts B and C, T-cell phenotype Th40 level 35% of CD3+ leukocytes
- Medically stable based on physical examination, medical history, labs, and vital signs
- Women of childbearing potential must have negative pregnancy tests at screening and before treatment
- Women of childbearing potential must agree to use approved birth control methods during the trial; men with female partners must agree to use double barrier contraception unless partner uses hormonal contraceptives or an intrauterine device
You will not qualify if you...
- Current or past malignancy except certain skin cancers
- Immune deficiency syndromes or history of bone marrow/organ transplantation
- Stage 2 or higher chronic kidney disease (eGFR <90 mL/min/1.73m2)
- Currently receiving immuno-modulatory treatment
- History of venous or arterial thromboembolic events or recent immobilization/surgery
- History of abnormal prothrombotic lab results or antiphospholipid syndrome
- Active, recurrent, or chronic infections including certain viral infections and non-healing wounds
- Recent or active hepatitis A, chronic hepatitis B or C, or HIV infection
- History of latent or active tuberculosis
- Receipt of live attenuated vaccines within 60 days before or planned during the study
- Abnormal coagulation or liver function tests beyond specified limits
- Planning elective surgery during the study period
- Pregnant, breastfeeding, or planning pregnancy during the study or within 120 days after last dose
- Recent history of bleeding disorders or contraindications to anticoagulation
- Hypersensitivity to antihistamines
- Body mass index less than 20 or greater than 35 kg/m2
- Active drug or alcohol abuse within one year or positive drug test at screening
- Participation in another investigational drug or device trial within 5 half-lives
- Prisoner status
- Any medical condition judged by the investigator to interfere with study participation
AI-Screening
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Trial Site Locations
Total: 5 locations
1
University of Alabama at Birmingham - Department of Medicina
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
Diablo Clinical Research Center
Walnut Creek, California, United States, 94598
Actively Recruiting
3
Barbara Davis Center - University of Colorado Anschuttz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
4
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
5
Rainier Clinical Research Center
Renton, Washington, United States, 98057
Actively Recruiting
Research Team
L
Lisa Boswell
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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