Pharmacokinetic Study to Compare Itepekimab Exposure When Administered With an Autoinjector Versus Prefilled Syringe

A Phase 1, Single-center, Open-label, Randomized, Parallel Group, Single-dose Study to Compare the Pharmacokinetics of Subcutaneous Itepekimab Administered With an Autoinjector Versus Prefilled Syringe in Healthy Participants

This Phase 1, single-center study will be conducted in an open-label, randomized, parallel design. Healthy male and female participants aged 18 to 65 years will receive a single dose of itepekimab subcutaneous (SC) administered by either a prefilled syringe (PFS) or an autoinjector (AI). Itepekimab will be administered by a trained healthcare professional (HCP).

Female and male participants will have a body weight between 50.0 and 100.0 kg and body mass index (BMI) >18.5 and ≤30 kg/m2.

Participants who satisfy the inclusion criteria will be randomized to one of the 2 study intervention groups:

• Itepekimab administered via AI (test)
• Itepekimab administered via PFS (reference) The randomization will be stratified by weight category (<70 kg, ≥70 to <80 kg and ≥80 kg) and injection site (abdomen, thigh, and arm).

Study duration for each participant is up to approximately 162 days, including:

• Screening period: up to 21 days
• Institutionalization: 2 days including 1 treatment day (Day 1)
• Follow-up period: 140 days (±5 days)
• End of study (EOS): Day 141 (± 5 days)

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: Itepekimab AI; Drug: Itepekimab PFS

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33014
      • Clinical Pharmacology of Miami Site Number : 8400001

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Having given written informed consent prior to undertaking any study-related procedure.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

• Any participant 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: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; Itepekimab administered via AI	Drug: Itepekimab AI; Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous AI; Other Names: SAR440340
Active Comparator: Cohort 2; Itepekimab administered via PFS	Drug: Itepekimab PFS; Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous PFS; Other Names: SAR440340

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of pharmacokinetic (PK) parameter of itepekimab: Cmax	Maximum plasma concentration of itepekimab	Baseline up to EOS (approximately Day 141)
Assessment of PK parameter of itepekimab: AUClast	AUClast: Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time tlast	Baseline up to EOS (approximately Day 141)
Assessment of PK parameter of itepekimab: AUC	AUC: Area under the plasma concentration versus time curve extrapolated to infinity	Baseline up to EOS (approximately Day 141)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of PK parameter of itepekimab: tmax	Time to reach Cmax of itepekimab	Baseline up to EOS (approximately Day 141)
Assessment of PK parameter of itepekimab: AUC0-28days	Area under the serum concentration versus time curve calculated using the trapezoidal method from time zero to 28 days	Baseline up to Day 28
Assessment of PK parameter of itepekimab: t1/2	Terminal half-life associated with the terminal slope (λz)	Baseline up to EOS (approximately Day 141)
Assessment of PK parameter of itepekimab: CL/F	Apparent total body clearance of a drug from the serum	Baseline up to EOS (approximately Day 141)
Assessment of PK parameter of itepekimab: Vss/F	Apparent Volume of Distribution at the steady state	Baseline up to EOS (approximately Day 141)
Incidence of treatment-emergent anti-itepekimab antibodies responses		Baseline up to EOS (approximately Day 141)
Number of participants with Adverse Events (including injection site reactions), Serious Adverse Events (SAE), Adverse Event of Special Interest (AESI)		Baseline up to EOS (approximately Day 141)

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2021
• Primary Completion (Actual): March 8, 2022
• Study Completion (Actual): March 8, 2022

Study Registration Dates

• First Submitted: October 24, 2023
• First Submitted That Met QC Criteria: October 29, 2023
• First Posted (Actual): November 2, 2023

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: October 29, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Chronic Disease; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: PKM16966; U1111-1260-3853 (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