Chronic Obstructive Pulmonary Disease
Conditions
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)
Interventions
DRUGItepekimab AI
Pharmaceutical form:Solution for injection; Route of administration: Subcutaneous AI
DRUGItepekimab PFS
Pharmaceutical form:Solution for injection; Route of administration: Subcutaneous PFS
Sponsors
Regeneron Pharmaceuticals
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of pharmacokinetic (PK) parameter of itepekimab: Cmax | Baseline up to EOS (approximately Day 141) | Maximum plasma concentration of itepekimab |
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Assessment of PK parameter of itepekimab: Vss/F | Baseline up to EOS (approximately Day 141) | Apparent Volume of Distribution at the steady state |
| Assessment of PK parameter of itepekimab: tmax | Baseline up to EOS (approximately Day 141) | Time to reach Cmax of itepekimab |
| 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) | — |
| Incidence of treatment-emergent anti-itepekimab antibodies responses | Baseline up to EOS (approximately Day 141) | — |
| 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 |
| Assessment of PK parameter of itepekimab: t1/2 | Baseline up to EOS (approximately Day 141) | Terminal half-life associated with the terminal slope (λz) |
Countries
United States
Outcome results
None listed