Healthy Volunteer
Conditions
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 (Process B) The secondary objectives of the study are: * Assess the safety and tolerability of a single SC dose of pozelimab produced by the 2 manufacturing processes * Assess the immunogenicity of pozelimab produced by the 2 manufacturing processes
Interventions
DRUGPozelimab
Single subcutaneous (SC) injection
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * 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 criteria
* 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess the time of the last positive concentration (AUClast) pharmacokinetic (PK) profile of pozelimab in Process A | Up to 16 weeks |
| Assess the time of the last positive concentration (AUClast) PK profile of pozelimab in Process B | Up to 16 weeks |
| Assess peak concentration (Cmax) PK profile of pozelimabin in Process A | Up to 16 weeks |
| Assess peak concentration (Cmax) PK profile of pozelimab in Process B | Up to 16 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of treatment emergent adverse events (TEAEs) | Up to 16 weeks |
| Incidence of anti-drug antibodies (ADA) to pozelimab over time | Up to 16 weeks |
Countries
Belgium
Outcome results
None listed