Study of a Single Subcutaneous Dose of Pozelimab Produced From Two Different Manufacturing Processes in Healthy Adult Participants

NCT ID: NCT04491838

Last Updated: 2021-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-03
• Study Completion Date: 2021-03-05

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

Conditions

Healthy Volunteer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Process A

Randomized 1:1

Group Type: EXPERIMENTAL

Pozelimab

Intervention Type: DRUG

Single subcutaneous (SC) injection

Process B

Randomized 1:1

Group Type: EXPERIMENTAL

Pozelimab

Intervention Type: DRUG

Single subcutaneous (SC) injection

Interventions

Pozelimab

Single subcutaneous (SC) injection

Intervention Type: DRUG

Other Intervention Names

REGN3918

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

Regeneron Study Site

Antwerp, , Belgium

Countries

Belgium

Other Identifiers

2020-002365-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

R3918-HV-2014

Identifier Type: -

Identifier Source: org_study_id