First-in-human Study to Assess Safety and Tolerability of a Single Subcutaneous Dose of SAR441255 in Lean to Overweight Subjects

• Status: Completed
• Trial end date: 2019-09-26
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sanofi

Criteria

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.