The purpose of this two-part multiple ascending dose study is to evaluate the safety and tolerability of multiple doses of MHS552 in adults with type 1 diabetes mellitus. Participants will be treated for 4 or 12 weeks followed by an 8 week follow-up period
This is a Phase 1b, randomized, investigator and participant blinded, placebo controlled, multiple ascending dose (MAD) study in adults with type 1 diabetes mellitus (adults aged 18-45 years, inclusive, diagnosed with T1DM within 5 years at the time of screening). This MAD study will be conducted in two sequential parts, Part A and Part B. In Part A, after an screening period of up to 28 days, participants will be randomized (in a 3:1 ratio) to MHS552 or placebo administered subcutaneously (s.c.) weekly for four weeks of treatment. Part A will consist of up to 3 cohorts (low, medium, high dose), with approximately 4-8 participants completing each cohort (total of approximately 16 participants). Participants will be followed-up during 8 weeks post last dose. The total duration of study participation of Part A is approximately 106 Days. In Part B, after a screening period of up to 28 days, approximately 12 participants will be randomized (in a 2:1 ratio) to MHS552 or placebo administered s.c. weekly for 12 weeks of treatment (dose level 4). Participants will be followed-up during 8 weeks post last dose with End of Study (EoS) visit at Day 134. The total duration of study participation of Part B is approximately 162 Days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs)
Numbers of participants with AEs and SAEs including vital signs, electrocardiograms (ECG) and laboratory results
Time frame: Part A: up to 12 weeks; Part B: up to 20 weeks
Area Under Plasma Concentration-time Curve calculated to the end of a dosing interval (AUCtau) for MHS552
Characterize the AUCtau profile following multiple doses of MHS552
Time frame: Part A: up to Day 78; Part B: up to Day 134
Maximum ObservBlood Concentrations (Cmax) for MHS552
Characterize the Cmax profile following multiple doses of MHS552
Time frame: Part A: up to Day 78; Part B: up to Day 134
Time to Reach Maximum Blood Concentrations (Tmax) of MHS552
Characterize the Tmax profile following multiple doses of MHS552
Time frame: Part A: up to Day 78; Part B: up to Day 134
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