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
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
Study Sites (1)
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