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

Sanofi

Status and phase: Completed; Phase 1

Conditions: Overweight; Healthy Subjects

Treatments: Drug: SAR441255; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04521738

U1111-1210-0180 (Other Identifier)

TDU15478

Details and patient eligibility

About

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)

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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48 participants in 2 patient groups, including a placebo group

SAR441255

Experimental group

Description:

Single dose, subcutaneous, escalating dose

Treatment:

Drug: SAR441255

Placebo

Placebo Comparator group

Description:

Single dose, subcutaneous, matched volume

Treatment:

Drug: placebo