Type1 Diabetes Clinical Trial
Official title:
A Phase 1b, Randomized, Single-blind, Placebo-controlled, Multiple Ascending Dose (MAD) Study to Assess the Steady-State Pharmacokinetics and DQ8 Blocking Efficacy of Orally Administered IMT-002 in Patients With Type 1 Diabetes and HLA-DQ8
This study is designed to characterize the safety, steady-state pharmacokinetics (PK) of IMT-002, and will serve as a dose range identification for the pharmacodynamic effect of blocking self-antigen presentation in adults with type 1 diabetes (T1D) having the human leukocyte antigen (HLA)-DQ8 gene.
This is a randomized, single-blind, placebo-controlled study that will include 4 ascending dose cohorts: 350 mg twice daily (BID), 1050 mg once daily (QD), 700 mg BID, and 1050 mg BID. Subjects will undergo prescreening for genetic typing and then screening procedures up to 28 days prior to the first dose to determine eligibility. T1D adults between 18 and 45 years of age, inclusive, who are positive for at least one gene encoding for HLA-DQ8 (DQA1*0301, DQB1*0302) will be enrolled. Each cohort will include 6 subjects on active drug, and the study will include 6 subjects total on placebo. Each cohort will participate in a 2-week dosing period. Enrollment of the cohorts will be sequentially staggered such that initial safety data after the first four subjects assigned to active treatment complete one week of treatment in each cohort will be reviewed before the next ascending dose cohort is enrolled. The safety reviews will include cumulative safety data for all subjects to that point. Subjects will have 5 scheduled clinic visits: screening, first day of dosing, 1 week after dosing begins, 2 weeks after dosing begins (end of treatment), and 1 week following the final dose. Subjects will self-administer study drug on non-clinic treatment days. Safety assessments will be conducted at all study visits. Insulin use (dose and frequency) will be monitored. Pharmacokinetic (PK) assessments will be evaluated at every visit during the treatment period to characterize the following: single dose PK, trough PK and steady PK. Pharmacodynamic (PD) and immunological assessments will be evaluated before, during and after treatment. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05536232 -
Residual Insulin Secretion in Patients With Type 1 Diabetes Under a Low Carbohydrate Diet or a Ketogenic Diet
|
N/A | |
| Completed |
NCT04255381 -
Yale-Harvard Hotel-based Closed-Loop Studies in Children (HY-GRAID)
|
N/A | |
| Active, not recruiting |
NCT06177691 -
Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes (CLVer): Extension Study
|
||
| Completed |
NCT04002557 -
Optimising Consultation Summaries to Promote Good Health
|
||
| Completed |
NCT05876273 -
Neural-net Artificial Pancreas (NAP)
|
N/A | |
| Withdrawn |
NCT03236558 -
The Role of the Thymus in Type I Diabetes.
|
N/A | |
| Completed |
NCT03179280 -
Effect of Dual-wave Insulin Bolus on Postprandial Glycaemia
|
N/A | |
| Recruiting |
NCT06253351 -
Real-world Use of Hybrid Closed Loop in Adolescents and Young Adults 15-25 Years of Age With Type 1 Diabetes
|
||
| Completed |
NCT01357603 -
Comparative Glucose Clamp Study of Wockhardt's Recombinant Insulin Analog Glargine(Glaritus) With Lantus in T1DM
|
Phase 1 | |
| Completed |
NCT04233034 -
Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes
|
Phase 3 | |
| Active, not recruiting |
NCT03782636 -
Interleukin-2 Therapy of Autoimmunity in Diabetes (ITAD)
|
Phase 2 | |
| Completed |
NCT04520971 -
Closed-loop Insulin Delivery in Pregnant Women With Type 1 Diabetes
|
N/A | |
| Recruiting |
NCT05766657 -
Evaluation of an Anti-inflammatory Diet in Autoimmune and Metabolic Diseases
|
N/A | |
| Completed |
NCT01838083 -
Euglycemic Clamp Study Comparing Two New Insulin Glargine Formulations in Subjects With Type 1 Diabetes Mellitus
|
Phase 1 |