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OpenTrials
Completed

NCT Number: NCT06114238

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

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)

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Pharmacology of Miami Site Number : 8400001

Miami, Florida, 33014, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Itepekimab AI

Drug

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

Other names: SAR440340/REGN3500

Itepekimab PFS

Drug

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

Other names: SAR440340/REGN3500

Primary outcomes

  1. Assessment of pharmacokinetic (PK) parameter of itepekimab: Cmax

    Time frame: Baseline up to EOS (approximately Day 141)

    Maximum plasma concentration of itepekimab

  2. Assessment of PK parameter of itepekimab: AUClast

    Time frame: 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

    Time frame: Baseline up to EOS (approximately Day 141)

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

Secondary outcomes

  1. Assessment of PK parameter of itepekimab: tmax

    Time frame: Baseline up to EOS (approximately Day 141)

    Time to reach Cmax of itepekimab

  2. Assessment of PK parameter of itepekimab: AUC0-28days

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Baseline up to EOS (approximately Day 141)

    Apparent Volume of Distribution at the steady state

  6. Incidence of treatment-emergent anti-itepekimab antibodies responses

    Time frame: 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)

    Time frame: Baseline up to EOS (approximately Day 141)

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 2, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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