Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Alpha-1 Antitrypsin · 2 trials · 2 indications
Beta cell function (measured by C peptide)
Safety and Tolerability: assessed by vital signs(systolic/diastolic blood pressure and heart rate), physical examination, routine safety lab tests, AEs and SAEs.
| Arm | Type | Description |
|---|---|---|
| Alpha1 Antitrypsin (Glassia) | EXPERIMENTAL | 60 mg/kg body weight |
| Alpha-1 Antitrypsin (Glassia) | EXPERIMENTAL | 120 mg/kg body weight |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Alpha-1 Antitrypsin 40mg (AAT, Glassia®) | EXPERIMENTAL | Subjects in this arm will receive a dose of 40 mg/kg throughout the study. |
| Alpha-1 Antitrypsin 60mg (AAT, Glassia®) | EXPERIMENTAL | Subjects in this arm will receive a dose of 60 mg/kg throughout the study. |
| Alpha-1 Antitrypsin 80mg (AAT, Glassia®) | EXPERIMENTAL | Subjects in this arm will receive a dose of 80 mg/kg throughout the study. |
| Name | Type | Description |
|---|---|---|
| Alpha-1 Antitrypsin | BIOLOGICAL | - |
| Placebo | OTHER | Placebo |
| Alpha-1 Antitrypsin 40mg (AAT, Glassia®) | DRUG | Each study group will undergo 3 treatment periods:12 weeks, 8 weeks and 4 weeks. |
| Alpha-1 Antitrypsin 60mg (AAT, Glassia®) | DRUG | Each study group will undergo 3 treatment periods:12 weeks, 8 weeks and 4 weeks. |
| Alpha-1 Antitrypsin 80mg (AAT, Glassia®) | DRUG | Each study group will undergo 3 treatment periods:12 weeks, 8 weeks and 4 weeks. |
Main Inclusion Criteria: * Subject (or parent/guardian) willing and able to sign an informed consent * Age 8-25 (inclusive) years * Recently diagnosed with T1DM * Basal C-peptide ≥ 0.2 pmol/mL * Positive for at least one diabetes-related autoantibody * Ability and consent to comply with completion ...
Alpha-1 Antitrypsin is being studied for use in Type 1 Diabetes Mellitus and New Onset Type-1 Diabetes. It is an investigational monoclonal antibody being developed by Kamada Ltd. (KMDA). The drug is currently in Phase 2 clinical development for these indications.
Alpha-1 Antitrypsin is a monoclonal antibody. Its specific molecular target has not been disclosed in available information. The drug is being investigated for its potential effects in Type 1 Diabetes Mellitus and New Onset Type-1 Diabetes.
Alpha-1 Antitrypsin is being developed by Kamada Ltd., a biopharmaceutical company traded under the ticker KMDA. The company is conducting clinical trials to evaluate the drug's safety and efficacy in Type 1 Diabetes Mellitus and New Onset Type-1 Diabetes.
Alpha-1 Antitrypsin is in Phase 2 clinical development for Type 1 Diabetes Mellitus and New Onset Type-1 Diabetes. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing to assess its safety and efficacy.
Alpha-1 Antitrypsin has been studied in two completed clinical trials. NCT01304537 was a Phase 1 study with 24 participants in Israel. NCT02005848 was a Phase 2 study with 70 participants in Israel, evaluating the drug in New Onset Type-1 Diabetes. Both trials are completed.
Alpha-1 Antitrypsin is the same as Glassia, as indicated by the Phase 2 trial title referencing Glassia®. The drug is being developed by Kamada Ltd. and is being studied for Type 1 Diabetes Mellitus and New Onset Type-1 Diabetes.