First-in-human Study to Assess Safety and Tolerability of a Single Subcutaneous Dose of SAR441255 in Lean to Overweight Subjects
- Registration Number
- NCT04521738
- Lead Sponsor
- Sanofi
- Brief Summary
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)
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description SAR441255 SAR441255 Single dose, subcutaneous, escalating dose Placebo placebo Single dose, subcutaneous, matched volume
- Primary Outcome Measures
Name Time Method Number of participants with adverse events Screening to Day 28
- Secondary Outcome Measures
Name Time Method Assessment of pharmacokinetic (PK) parameter: Cmax Baseline to 96 hrs Maximum plasma concentration
Assessment of PK parameter: AUC Baseline to 96 hrs Area under the plasma concentration versus time curve (AUC)
Assessment of PK parameter: tmax Baseline to 96 hrs Time to reach Cmax
Assessment of pharmacodynamics (PD): glucose profile Baseline to 24 hrs Change from baseline in glucose profile
Assessment of PD: insulin profile Baseline to 24 hrs Change from baseline in insulin profile
Assessment of PD: C-peptide profile Baseline to 24 hrs Change from baseline in C-peptide profile
Trial Locations
- Locations (1)
Investigational site number 8400001
🇺🇸Knoxville, Tennessee, United States