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

• Sponsor: Sanofi (Industry)
• Overall Status: Completed
• CT.gov ID: NCT06114238
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 2
• Actual Duration (Months): 5.7
• Patients Per Site Per Month: 15.8

Study Details

Study Description

Brief Summary

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)

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Drug: Itepekimab AI; Drug: Itepekimab PFS	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Sep 16, 2021
• Actual Primary Completion Date: Mar 8, 2022
• Actual Study Completion Date: Mar 8, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Assessment of pharmacokinetic (PK) parameter of itepekimab: Cmax [Baseline up to EOS (approximately Day 141)]

   Maximum plasma concentration of itepekimab

2. Assessment of PK parameter of itepekimab: AUClast [Baseline up to EOS (approximately Day 141)]

   AUClast: Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time tlast

3. Assessment of PK parameter of itepekimab: AUC [Baseline up to EOS (approximately Day 141)]

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

Secondary Outcome Measures

1. Assessment of PK parameter of itepekimab: tmax [Baseline up to EOS (approximately Day 141)]

   Time to reach Cmax of itepekimab

2. Assessment of PK parameter of itepekimab: AUC0-28days [Baseline up to Day 28]

   Area under the serum concentration versus time curve calculated using the trapezoidal method from time zero to 28 days

3. Assessment of PK parameter of itepekimab: t1/2 [Baseline up to EOS (approximately Day 141)]

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

4. Assessment of PK parameter of itepekimab: CL/F [Baseline up to EOS (approximately Day 141)]

   Apparent total body clearance of a drug from the serum

5. Assessment of PK parameter of itepekimab: Vss/F [Baseline up to EOS (approximately Day 141)]

   Apparent Volume of Distribution at the steady state

6. Incidence of treatment-emergent anti-itepekimab antibodies responses [Baseline up to EOS (approximately Day 141)]

7. 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)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Pharmacology of Miami Site Number : 8400001	Miami	Florida	United States	33014

Sponsors and Collaborators

• Sanofi

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sanofi
• ClinicalTrials.gov Identifier: NCT06114238
• Other Study ID Numbers: PKM16966; U1111-1260-3853
• First Posted: Nov 2, 2023
• Last Update Posted: Nov 2, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Nov 2, 2023