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

Overweight Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Subcutaneous Doses of SAR441255 in Lean to Overweight Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04521738
• Other study ID #: TDU15478
• Secondary ID: U1111-1210-0180
• Status: Completed
• Phase: Phase 1
• Start date: April 25, 2019
• Est. completion date: September 26, 2019

Study information

• Verified date: April 2022
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 26, 2019
• Est. primary completion date: September 26, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Subjects
• Overweight

Intervention

Drug:
• SAR441255
Pharmaceutical form:solution for injection Route of administration: subcutaneous
• placebo
Pharmaceutical form:solution for injection Route of administration: subcutaneous

Locations

Country	Name	City	State
United States	Investigational site number 8400001	Knoxville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events		Screening to Day 28
Secondary	Assessment of pharmacokinetic (PK) parameter: Cmax	Maximum plasma concentration	Baseline to 96 hrs
Secondary	Assessment of PK parameter: AUC	Area under the plasma concentration versus time curve (AUC)	Baseline to 96 hrs
Secondary	Assessment of PK parameter: tmax	Time to reach Cmax	Baseline to 96 hrs
Secondary	Assessment of pharmacodynamics (PD): glucose profile	Change from baseline in glucose profile	Baseline to 24 hrs
Secondary	Assessment of PD: insulin profile	Change from baseline in insulin profile	Baseline to 24 hrs
Secondary	Assessment of PD: C-peptide profile	Change from baseline in C-peptide profile	Baseline to 24 hrs