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

Healthy Volunteer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04491838
• Other study ID #: R3918-HV-2014
• Secondary ID: 2020-002365-33
• Status: Completed
• Phase: Phase 1
• Start date: August 3, 2020
• Est. completion date: March 5, 2021

Study information

• Verified date: March 2021
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 5, 2021
• Est. primary completion date: March 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• Pozelimab
Single subcutaneous (SC) injection

Locations

Country	Name	City	State
Belgium	Regeneron Study Site	Antwerpen

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the time of the last positive concentration (AUClast) pharmacokinetic (PK) profile of pozelimab in Process A		Up to 16 weeks
Primary	Assess the time of the last positive concentration (AUClast) PK profile of pozelimab in Process B		Up to 16 weeks
Primary	Assess peak concentration (Cmax) PK profile of pozelimabin in Process A		Up to 16 weeks
Primary	Assess peak concentration (Cmax) PK profile of pozelimab in Process B		Up to 16 weeks
Secondary	Incidence of treatment emergent adverse events (TEAEs)		Up to 16 weeks
Secondary	Incidence of anti-drug antibodies (ADA) to pozelimab over time		Up to 16 weeks