Status:
COMPLETED
Pharmacokinetic Study to Compare Itepekimab Exposure When Administered With an Autoinjector Versus Prefilled Syringe
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 sub...
Eligibility Criteria
Inclusion
- • Having given written informed consent prior to undertaking any study-related procedure.
Exclusion
- 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.
Key Trial Info
Start Date :
September 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 8 2022
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06114238
Start Date
September 16 2021
End Date
March 8 2022
Last Update
September 19 2024
Active Locations (1)
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1
Clinical Pharmacology of Miami Site Number : 8400001
Miami, Florida, United States, 33014