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

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06114238
• Other study ID #: PKM16966
• Secondary ID: U1111-1260-3853
• Status: Completed
• Phase: Phase 1
• Start date: September 16, 2021
• Est. completion date: March 8, 2022

Study information

• Verified date: October 2023
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 8, 2022
• Est. primary completion date: March 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Itepekimab AI
Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous AI
• Itepekimab PFS
Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous PFS

Locations

Country	Name	City	State
United States	Clinical Pharmacology of Miami Site Number : 8400001	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of pharmacokinetic (PK) parameter of itepekimab: Cmax	Maximum plasma concentration of itepekimab	Baseline up to EOS (approximately Day 141)
Primary	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)
Primary	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	Assessment of PK parameter of itepekimab: tmax	Time to reach Cmax of itepekimab	Baseline up to EOS (approximately Day 141)
Secondary	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
Secondary	Assessment of PK parameter of itepekimab: t1/2	Terminal half-life associated with the terminal slope (?z)	Baseline up to EOS (approximately Day 141)
Secondary	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)
Secondary	Assessment of PK parameter of itepekimab: Vss/F	Apparent Volume of Distribution at the steady state	Baseline up to EOS (approximately Day 141)
Secondary	Incidence of treatment-emergent anti-itepekimab antibodies responses		Baseline up to EOS (approximately Day 141)
Secondary	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)