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

NCT04491838 | Completed Phase 1 FDA Drug

• 2 other identifiers: R3918-HV-20142020-002365-33
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• 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

Study Arms (2)

Process A

EXPERIMENTAL

Randomized 1:1

Drug: Pozelimab

Process B

EXPERIMENTAL

Randomized 1:1

Drug: Pozelimab

Interventions

Pozelimab DRUG

Single subcutaneous (SC) injection

Also known as: REGN3918

Process A; Process B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (1)

Regeneron Study Site

Antwerp, B-2060, Belgium

Location

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 29, 2020
• Study Start: August 3, 2020
• Primary Completion: March 5, 2021
• Study Completion: March 5, 2021
• Last Updated: March 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
• Access Criteria: Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency \[EMA\], Pharmaceuticals and Medical Devices Agency \[PMDA\], etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).

Locations

BE (1)