Primary Objective: To assess the safety and tolerability of SAR441255 after ascending single subcutaneous (SC) doses Secondary Objectives: To assess the pharmacokinetic parameters of SAR441255 in plasma after ascending single SC doses To assess the pharmacodynamic effects on glycemic parameters (fasting and postprandial glucose, C-peptide and insulin)
Study duration per participant is approximately 8 weeks including a 21-day screening and baseline phase, a 4-day treatment phase and a 28-day follow up period after dosing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
Investigational site number 8400001
Knoxville, Tennessee, United States
Number of participants with adverse events
Time frame: Screening to Day 28
Assessment of pharmacokinetic (PK) parameter: Cmax
Maximum plasma concentration
Time frame: Baseline to 96 hrs
Assessment of PK parameter: AUC
Area under the plasma concentration versus time curve (AUC)
Time frame: Baseline to 96 hrs
Assessment of PK parameter: tmax
Time to reach Cmax
Time frame: Baseline to 96 hrs
Assessment of pharmacodynamics (PD): glucose profile
Change from baseline in glucose profile
Time frame: Baseline to 24 hrs
Assessment of PD: insulin profile
Change from baseline in insulin profile
Time frame: Baseline to 24 hrs
Assessment of PD: C-peptide profile
Change from baseline in C-peptide profile
Time frame: Baseline to 24 hrs
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