Multiple Ascending Dose Study of MHS552 in Adults With Type 1 Diabetes Mellitus
Type 1 Diabetes Mellitus
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring type 1 diabetes mellitus, T1DM
Eligibility Criteria
Inclusion Criteria:
- Adult men and women ages 18 to 45, inclusive, body weight between ≥40 to ≤150 kg, inclusive, with T1DM, a maximum of 5 years from T1DM diagnosis at screening.
- Evidence of one or more T1DM autoantibody(ies) including glutamic acid decarboxylase (anti GAD), protein tyrosine, phosphatase-like protein (anti-IA-2); zinc transporter 8 (anti-ZnT8); islet cell (cytoplasmic) (anti-ICA)
- Residual pancreatic β-cell function (fasting C-peptide >100 pmol/L [0.30 ng/mL] or random C peptide >200 pmol/L [0.60 ng/mL])
Exclusion Criteria:
- History of hypersensitivity to drugs of similar biological class, IL-2 protein analogues, or immunoglobulin (IgG1) proteins, hypersensitivity to any components of the study drug, or history of severe hypersensitivity reaction or anaphylaxis to biological agents, e.g. human monoclonal antibody.
- Use of other investigational drugs or use of immunosuppressive agents at the time of enrollment, or within 5 half-lives of enrollment, or until the expected PD effect has returned to baseline, whichever is longer; or longer if required by local regulations.
- Diabetes forms other than autoimmune type 1 such as maturity-onset diabetes of the young (MODY), latent autoimmune diabetes of the adult (LADA), acquired diabetes (secondary to medications or surgery), type 2 diabetes by judgement of the investigator.
- Diabetic ketoacidosis within 2 weeks.
- Polyglandular auto-immune disease, including but not limited to: Addison's disease, pernicious anemia, celiac sprue and psoriasis. Treated, stable Hashimoto's thyroiditis is not exclusionary.
- History of capillary leak syndrome (CLS).
- Ongoing, and up to 2 weeks prior to screening, initiation of medications or change in dose of medications that may affect glucose control (e.g, systemic steroids, thiazides, beta blockers).
Other protocol-defined inclusion/exclusion criteria may apply
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Placebo Comparator
Experimental
Experimental
Experimental
Placebo Comparator
Part A: Cohort 1 - MHS552 low dose
Part A: Cohort 1, 2, 3 - Placebo
Part A: Cohort 2 - MHS552 medium dose
Part A: Cohort 3 - MHS552 high dose
Part B: MHS552
Part B: Placebo
Participants will receive MHS552 low dose once weekly subcutaneously for 4 weeks
Participants will receive placebo once weekly subcutaneously for 4 weeks
Participants will receive MHS552 medium dose once weekly subcutaneously for 4 weeks
Participants will receive MHS552 high dose once weekly subcutaneously for 4 weeks
Participants will MHS552 (dose to be determined) once weekly subcutaneously for 12 weeks
Participants will receive placebo once weekly subcutaneously for 12 weeks