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

Sanofi

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: placebo; Biological: Keyhole limpet hemocyanin; Drug: SAR441344

Study type: Interventional

Funder types: Industry

Identifiers

NCT05845996

TDU15525-TDR15526

U1111-1217-2909 (Registry Identifier)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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56 participants in 2 patient groups, including a placebo group

SAR441344

Experimental group

Description:

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

Treatment:

Drug: SAR441344

Biological: Keyhole limpet hemocyanin

placebo

Placebo Comparator group

Description:

matching placebo

Treatment:

Biological: Keyhole limpet hemocyanin

Drug: placebo