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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: SAR441344; Biological: Keyhole limpet hemocyanin; Drug: placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78744
      • PPD-Site Number:8400001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo; matching placebo	Biological: Keyhole limpet hemocyanin; Subcutaneous Lyophilized powder for reconstitution; Drug: placebo; Solution for intravenous/subcutaneous injection
Experimental: SAR441344; Single or multiple Ascending dose of SAR441344 Dose 1 administered intravenously and/or subcutaneously	Drug: SAR441344; Solution for intravenous/subcutaneous injection; Biological: Keyhole limpet hemocyanin; Subcutaneous Lyophilized powder for reconstitution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Number of participants with adverse event(AE)	Number of participants with AE from baseline to day 127	From baseline to day 127
Part 2: Number of participants with adverse event (AE)	Number of participants with AE from baseline to day 155	From baseline to day 155

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of PK parameter: Cmax	Maximum plasma concentration (Cmax) observed	From Day 1 to Day 127 and to Day 155
Assessment of PK parameter: tmax	First time to reach Cmax (tmax)	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	From Day 1 to Day 127
Assessment of PK parameter: AUC	From Day 1 to Day 127	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)	From day 1 to Day 155
Assessment of PK parameter: Ctrough	Plasma concentration observed just before treatment administration during repeated dosing	From Day 1 to Day 155
Assessment of PK parameter: t1/2z	Terminal half-life associated with the terminal slope (λz)	From Day 1 to Day 127 and Day 155
Assessment of PK parameter: CL(/F)	From Day 1 to Day 127	Apparent total body clearance of a drug from the plasma
Assessment of PK parameter: CLss(/F)	From day 1 to Day 155	Apparent total body clearance of a drug from the plasma
Anti-SAR441344 antibodies	Number of subjects with treatment emergent anti-drug antibody formation	From Day 1 to Day 127 and Day 155
Assessment of anti-KLH IgG and IgM	Measurement of anti-KLH IgG and IgM levels in response to KLH immunization	From Day 1 to Day 127 and Day 155
AE attributed to KLH immunization	Number of participants with AE attributed to KLH immunization	From Day 1 to Day 127 and Day 155

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2018
• Primary Completion (Actual): April 10, 2020
• Study Completion (Actual): April 10, 2020

Study Registration Dates

• First Submitted: April 26, 2023
• First Submitted That Met QC Criteria: April 26, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic; Keyhole-limpet hemocyanin
• Other Study ID Numbers: TDU15525-TDR15526; U1111-1217-2909 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No