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COMPLETEDPhase 1NCT04521738

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

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 p...

Lead sponsor: Sanofi•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Sanofi

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.

Age

18 - 55 years

Sex

ALL

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: September 22, 2025Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE1

Enrollment48

Start dateApr 2019

Last updatedSep 22, 2025

Condition

Overweight Healthy Subjects

Locations shown

Investigational site number 8400001

Knoxville, Tennessee

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 22, 2025Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions