Clinical trial NCT06114238: Pharmacokinetic Study to Compare Itepekimab Exposure When Administered With an Autoinjector Versus Prefilled Syringe
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2023-11-02
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of pharmacokinetic (PK) parameter of itepekimab: Cmax
timeFrame: Baseline up to EOS (approximately Day 141)
measure: Assessment of PK parameter of itepekimab: AUClast
timeFrame: Baseline up to EOS (approximately Day 141)
measure: Assessment of PK parameter of itepekimab: AUC
timeFrame: Baseline up to EOS (approximately Day 141)
Secondary outcomes:
measure: Assessment of PK parameter of itepekimab: tmax
timeFrame: Baseline up to EOS (approximately Day 141)
measure: Assessment of PK parameter of itepekimab: AUC0-28days
timeFrame: Baseline up to Day 28
measure: Assessment of PK parameter of itepekimab: t1/2
timeFrame: Baseline up to EOS (approximately Day 141)
measure: Assessment of PK parameter of itepekimab: CL/F
timeFrame: Baseline up to EOS (approximately Day 141)
measure: Assessment of PK parameter of itepekimab: Vss/F
timeFrame: Baseline up to EOS (approximately Day 141)
measure: Incidence of treatment-emergent anti-itepekimab antibodies responses
timeFrame: Baseline up to EOS (approximately Day 141)
measure: Number of participants with Adverse Events (including injection site reactions), Serious Adverse Events (SAE), Adverse Event of Special Interest (AESI)
timeFrame: Baseline up to EOS (approximately Day 141)
Other outcomes:
Locations:
city: Miami
country: United States
facility: Clinical Pharmacology of Miami Site Number : 8400001
state: Florida
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: