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OpenTrials
Completed

NCT Number: NCT05845996

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

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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Key information

Conditions

Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PPD-Site Number:8400001

Austin, Texas, 78744, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SAR441344

Drug

Solution for intravenous/subcutaneous injection

Placebo

Drug

Solution for intravenous/subcutaneous injection

keyhole limpet hemocyanin

Biological

Subcutaneous Lyophilized powder for reconstitution

Primary outcomes

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

    Time frame: From baseline to day 127

    Number of participants with AE from baseline to day 127

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

    Time frame: From baseline to day 155

    Number of participants with AE from baseline to day 155

Secondary outcomes

  1. Assessment of PK parameter: Cmax

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

    Maximum plasma concentration (Cmax) observed

  2. Assessment of PK parameter: tmax

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

    First time to reach Cmax (tmax)

  3. Assessment of PK parameter: AUClast

    Time frame: From Day 1 to Day 127

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

  4. Assessment of PK parameter: AUC

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

    From Day 1 to Day 127

  5. Assessment of PK parameter: AUC0-tau

    Time frame: From day 1 to Day 155

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

  6. Assessment of PK parameter: Ctrough

    Time frame: From Day 1 to Day 155

    Plasma concentration observed just before treatment administration during repeated dosing

  7. Assessment of PK parameter: t1/2z

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

    Terminal half-life associated with the terminal slope (λz)

  8. Assessment of PK parameter: CL(/F)

    Time frame: Apparent total body clearance of a drug from the plasma

    From Day 1 to Day 127

  9. Assessment of PK parameter: CLss(/F)

    Time frame: Apparent total body clearance of a drug from the plasma

    From day 1 to Day 155

  10. Anti-SAR441344 antibodies

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

    Number of subjects with treatment emergent anti-drug antibody formation

  11. Assessment of anti-KLH IgG and IgM

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

    Measurement of anti-KLH IgG and IgM levels in response to KLH immunization

  12. AE attributed to KLH immunization

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

    Number of participants with AE attributed to KLH immunization

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

A Randomized, Double-blind, Parallel Design, Placebo-controlled Single and Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous and Subcutaneous Doses of SAR441344 in Healthy Adult Subjects

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 6, 2023
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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