A 48-week Phase 2 Multicenter Controlled Pharmacokinetic and Pilot Efficacy Trial of Subcutaneous OPT101 in Patients With Recent Onset Type 1 Diabetes Mellitus
Op-T LLC
Summary
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.
Description
This multipart study begins with an open label exploration of tolerance and pharmacokinetics of subcutaneously (SC) administered OPT101, given at increasing doses of 1.0, 1.5, or 2.0 mg/kg three times per week for two weeks to separate sequential cohorts of six adult patients (n=18 total) diagnosed with type 1 diabetes mellitus within 20 years of screening. In this Part A, serum C-peptide levels will not be a consideration. In Part B, the highest tolerated dose will then be tested over one year in a total of n=27 subjects having C-peptide 0.2 ng/ml, with 12 diagnosed within 1 to 5 years of sc…
Eligibility
- Age range
- 18–50 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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…
Interventions
- DrugOPT101
Subcutaneous injection.
- OtherOPT101 Placebo to Match (PTM)
5% Dextrose (w/v)
Locations (5)
- University of Alabama at Birmingham - Department of MedicinaBirmingham, Alabama
- Diablo Clinical Research CenterWalnut Creek, California
- Barbara Davis Center - University of Colorado Anschuttz Medical CampusAurora, Colorado
- University of Chicago Medical CenterChicago, Illinois
- Rainier Clinical Research CenterRenton, Washington