Status:
COMPLETED
Study of a Single Subcutaneous Dose of Pozelimab Produced From Two Different Manufacturing Processes in Healthy Adult Participants
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The primary objective of the study is to compare the pharmacokinetic(PK) profile of pozelimab produced by the original manufacturing process (Process A) compared to a second manufacturing process (Pro...
Eligibility Criteria
Inclusion
- Key
- Has a body weight of 55 kg to 100 kg and a body mass index between 18 kg/m2 and 30 kg/m2 inclusive at the screening visit
- Judged to be in good health based on medical history, physical examination, vital signs measurements, and ECG performed at screening and/or prior to administration of initial dose of study drug
- Is in good health based on laboratory safety testing obtained at the screening visit. NOTE: Subject with a history of Gilbert's disease can be enrolled in the study
- Willing to undergo vaccination against N meningitidis unless subjects have documentation of completed series of vaccinations within the past 2 years of the screening visit
- Must have two negative COVID-19 tests within 7 days prior to study drug administration as defined in the protocol
- Key
Exclusion
- History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease, as assessed by the investigator
- Hospitalization (\>24 h) for any reason within 90 days of the screening visit
- Has a confirmed positive drug test result at the screening visit and/or prior to enrollment; and/or a history of recreational drug use (eg, marijuana) and/or drug or alcohol abuse within a year prior to the screening visit
- Is positive for HIV, hepatitis B, or hepatitis C antibody as defined in the protocol
- Known or suspected COVID-19 disease
- History of tuberculosis, systemic fungal diseases, or meningococcal infection
- Known allergy or intolerance to penicillin class antibiotics or macrolides; any contraindication to azrithromycin per local prescribing information
- Note: Other protocol-defined Inclusion/ Exclusion criteria apply
Key Trial Info
Start Date :
August 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 5 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04491838
Start Date
August 3 2020
End Date
March 5 2021
Last Update
March 23 2021
Active Locations (1)
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1
Regeneron Study Site
Antwerp, Belgium, B-2060