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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-08

Study Completion Date

2020-04-10

Brief Summary

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

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Detailed Description

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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.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SAR441344

Single or multiple Ascending dose of SAR441344 Dose 1 administered intravenously and/or subcutaneously

Group Type EXPERIMENTAL

SAR441344

Intervention Type DRUG

Solution for intravenous/subcutaneous injection

Keyhole limpet hemocyanin

Intervention Type BIOLOGICAL

Subcutaneous Lyophilized powder for reconstitution

placebo

matching placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Solution for intravenous/subcutaneous injection

Keyhole limpet hemocyanin

Intervention Type BIOLOGICAL

Subcutaneous Lyophilized powder for reconstitution

Interventions

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SAR441344

Solution for intravenous/subcutaneous injection

Intervention Type DRUG

placebo

Solution for intravenous/subcutaneous injection

Intervention Type DRUG

Keyhole limpet hemocyanin

Subcutaneous Lyophilized powder for reconstitution

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes