Clinical trial NCT04491838: Study of a Single Subcutaneous Dose of Pozelimab Produced From Two Different Manufacturing Processes in Healthy Adult Participants
Official title: A Randomized, Open-Label, Parallel Group Study of the Pharmacokinetics, Safety, and Tolerability of a Single Subcutaneous Dose of Pozelimab Produced From Two Different Manufacturing Processes in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2020-07-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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/ Exclusion criteria apply

Primary outcomes:
measure: Assess the time of the last positive concentration (AUClast) pharmacokinetic (PK) profile of pozelimab in Process A
timeFrame: Up to 16 weeks
measure: Assess the time of the last positive concentration (AUClast) PK profile of pozelimab in Process B
timeFrame: Up to 16 weeks
measure: Assess peak concentration (Cmax) PK profile of pozelimabin in Process A
timeFrame: Up to 16 weeks
measure: Assess peak concentration (Cmax) PK profile of pozelimab in Process B
timeFrame: Up to 16 weeks
Secondary outcomes:
measure: Incidence of treatment emergent adverse events (TEAEs)
timeFrame: Up to 16 weeks
measure: Incidence of anti-drug antibodies (ADA) to pozelimab over time
timeFrame: Up to 16 weeks
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: Regeneron Study Site
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: