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Clinical Trials/NCT04521738
NCT04521738CompletedPhase 1

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

Sanofi1 site in 1 country48 target enrollmentStarted: April 25, 2019Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Sanofi
Enrollment
48
Locations
1
Primary Endpoint
Number of participants with adverse events

Study Overview

Brief 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)

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

SAR441255

Experimental

Single dose, subcutaneous, escalating dose

Intervention: SAR441255 (Drug)

Placebo

Placebo Comparator

Single dose, subcutaneous, matched volume

Intervention: placebo (Drug)

Outcomes

Primary Outcomes

Number of participants with adverse events

Time Frame: Screening to Day 28

Secondary Outcomes

  • Assessment of pharmacokinetic (PK) parameter: Cmax(Baseline to 96 hrs)
  • Assessment of PK parameter: AUC(Baseline to 96 hrs)
  • Assessment of PK parameter: tmax(Baseline to 96 hrs)
  • Assessment of pharmacodynamics (PD): glucose profile(Baseline to 24 hrs)
  • Assessment of PD: insulin profile(Baseline to 24 hrs)
  • Assessment of PD: C-peptide profile(Baseline to 24 hrs)

Investigators

Sponsor
Sanofi
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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