Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous and Subcutaneous Single and Repeated Doses of SAR441344 in Healthy Adult Subjects

Sanofi56 enrolled

Overview

Primary Objective is the tolerability and safety of ascending single and repeated intravenous infusion (IV) and/or subcutaneous (SC) administration of SAR441344

The study duration of Part 1 is approximately 22 weeks, including a treatment period of 1 day; The study duration of Part 2 is approximately 26 weeks for each subject, including a treatment period of 29 days.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Healthy Volunteers

Interventions

SAR441344DRUG

Solution for intravenous/subcutaneous injection

placeboDRUG

Solution for intravenous/subcutaneous injection

Keyhole limpet hemocyaninBIOLOGICAL

Subcutaneous Lyophilized powder for reconstitution

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria \- Having given written informed consent prior to undertaking any study-related procedure. Exclusion criteria \- Any subject who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations (1)

PPD-Site Number:8400001

Austin, Texas, United States

Outcomes

Primary Outcomes

Part 1: Number of participants with adverse event(AE)

Number of participants with AE from baseline to day 127

Time frame: From baseline to day 127

Part 2: Number of participants with adverse event (AE)

Number of participants with AE from baseline to day 155

Time frame: From baseline to day 155

Secondary Outcomes

Assessment of PK parameter: Cmax

Maximum plasma concentration (Cmax) observed

Time frame: From Day 1 to Day 127 and to Day 155

Assessment of PK parameter: tmax

First time to reach Cmax (tmax)

Time frame: From Day 1 to Day 127 and Day 155

Assessment of PK parameter: AUClast

Area under the plasma concentration versus time curve from time zero to the real time

Time frame: From Day 1 to Day 127

Assessment of PK parameter: AUC

From Day 1 to Day 127

Time frame: Area under the plasma concentration versus time curve extrapolated to infinity

Assessment of PK parameter: AUC0-tau

Area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval (336 hours)

Time frame: From day 1 to Day 155

Assessment of PK parameter: Ctrough

Plasma concentration observed just before treatment administration during repeated dosing

Data from ClinicalTrials.gov

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