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

NCT06114238 | Completed Phase 1 FDA Drug

• 2 other identifiers: PKM16966U1111-1260-3853
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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)

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Assessment of PK parameter of itepekimab: tmax

  Baseline up to EOS (approximately Day 141)

• Assessment of PK parameter of itepekimab: AUC0-28days

  Baseline up to Day 28

• Assessment of PK parameter of itepekimab: t1/2

  Baseline up to EOS (approximately Day 141)

• Assessment of PK parameter of itepekimab: CL/F

  Baseline up to EOS (approximately Day 141)

• Assessment of PK parameter of itepekimab: Vss/F

  Baseline up to EOS (approximately Day 141)

Study Arms (2)

Cohort 1

EXPERIMENTAL

Itepekimab administered via AI

Drug: Itepekimab AI

Cohort 2

ACTIVE COMPARATOR

Itepekimab administered via PFS

Drug: Itepekimab PFS

Interventions

Itepekimab AI DRUG

Pharmaceutical form:Solution for injection; Route of administration: Subcutaneous AI

Also known as: SAR440340/REGN3500

Cohort 1

Itepekimab PFS DRUG

Pharmaceutical form:Solution for injection; Route of administration: Subcutaneous PFS

Also known as: SAR440340/REGN3500

Cohort 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

Clinical Pharmacology of Miami Site Number : 8400001

Miami, Florida, 33014, United States

Location

Related Links

• PKM16966 Plain language Results Summary

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

itepekimab

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: November 2, 2023
• Study Start: September 16, 2021
• Primary Completion: March 8, 2022
• Study Completion: March 8, 2022
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)