| Trial ID: | L4928 |
| Source ID: | NCT05428943
|
| Associated Drug: |
Opt101
|
| Title: |
OPT101 in Type 1 Diabetes Patients
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 1
|
| Interventions: |
DRUG: OPT101
|
| Outcome Measures: |
Primary: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, Treatment related adverse events will be recorded and assessed by CTCAE v4.0, 90 days | Secondary: Serum samples collected to determine AUC0-t, Blood samples will be collected to determine the serum concentrations of OPT101 (mg/kg), 90 days|Serum samples collected to determine Cmax, Blood samples will be collected to determine the serum concentrations of OPT101 (mg/kg), 90 days|Serum samples collected to determine CL/F, Blood samples will be collected to determine the serum concentrations of OPT101 (mg/kg), 90 days|Serum samples collected to determine t1/2, Blood samples will be collected to determine the serum concentrations of OPT101 (mg/kg), 90 days|Serum samples collected to determine HbA1C from baseline pre mixed meal tolerance test, 90 days|Serum samples collected to determine c-peptide post mixed meal tolerance test, 90 days|Serum samples collected to determine glucose levels (mmol/L) pre and post mixed meal tolerance test, 90 days
|
| Sponsor/Collaborators: |
Sponsor: Op-T LLC
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
22
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: OTHER
|
| Start Date: |
2022-09-27
|
| Completion Date: |
2024-02-21
|
| Results First Posted: |
|
| Last Update Posted: |
2024-05-03
|
| Locations: |
Diablo Clinical Research Center, Walnut Creek, California, 94598, United States|Rainier Clinical Research Center, Renton, Washington, 98057, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT05428943
|
