Healthy Subjects, Overweight
Conditions
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.
Interventions
DRUGSAR441255
Pharmaceutical form:solution for injection Route of administration: subcutaneous
DRUGplacebo
Pharmaceutical form:solution for injection Route of administration: subcutaneous
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
: * Male and female subjects, between 18 and 55 years of age, inclusive * Body Mass Index ≥20 and ≤30 kg/m2 * Body weight between 65 and 90 kg, inclusive * No concomitant medication * Fasting Plasma Glucose \<126 mg/dL * Hemoglobin A1c \<6.5% * Triglycerides \<300 mg/dL * Low-density lipoprotein (LDL) Cholesterol \<200 mg/dL * Permanent sterile or postmenopausal, if female
Exclusion criteria
* Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, gynecologic (if female), ocular, or infectious disease, or signs of acute illness. * Any medication (including over the counter products and any other herbal/alternative remedies such as St John's Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication; any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events | Screening to Day 28 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 pharmacokinetic (PK) parameter: Cmax | Baseline to 96 hrs | Maximum plasma concentration |
| 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 |
| Assessment of pharmacodynamics (PD): glucose profile | Baseline to 24 hrs | Change from baseline in glucose profile |
Countries
United States
Outcome results
None listed