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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1260-3853 | Registry Identifier | ICTRP | |
| PKM16966 | Other Identifier | Sanofi Identifier |
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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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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:
Study duration for each participant is up to approximately 162 days, including:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Itepekimab administered via AI |
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| Cohort 2 | Active Comparator | Itepekimab administered via PFS |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Itepekimab AI | Drug | Pharmaceutical form:Solution for injection; Route of administration: Subcutaneous AI |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of PK parameter of itepekimab: tmax | Time to reach Cmax of itepekimab | Baseline up to EOS (approximately Day 141) |
| 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 |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology of Miami Site Number : 8400001 | Miami | Florida | 33014 | United States |
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| Label | URL |
|---|---|
| PKM16966 Plain language Results Summary | View source |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| C000720033 | itepekimab |
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| Itepekimab PFS | Drug | Pharmaceutical form:Solution for injection; Route of administration: Subcutaneous PFS |
|
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| Baseline up to Day 28 |
| Assessment of PK parameter of itepekimab: t1/2 | Terminal half-life associated with the terminal slope (λz) | Baseline up to EOS (approximately Day 141) |
| 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) |
| Assessment of PK parameter of itepekimab: Vss/F | Apparent Volume of Distribution at the steady state | Baseline up to EOS (approximately Day 141) |
| Incidence of treatment-emergent anti-itepekimab antibodies responses | Baseline up to EOS (approximately Day 141) |
| 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) |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |