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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-25

Study Completion Date

2019-09-26

Brief Summary

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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)

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Detailed Description

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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.

Conditions

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Overweight Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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SAR441255

Single dose, subcutaneous, escalating dose

Group Type EXPERIMENTAL

SAR441255

Intervention Type DRUG

Pharmaceutical form:solution for injection

Route of administration: subcutaneous

Placebo

Single dose, subcutaneous, matched volume

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Pharmaceutical form:solution for injection

Route of administration: subcutaneous

Interventions

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SAR441255

Pharmaceutical form:solution for injection

Route of administration: subcutaneous

Intervention Type DRUG

placebo

Pharmaceutical form:solution for injection

Route of administration: subcutaneous

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes