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OpenTrials
Completed

NCT Number: NCT04491838

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

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

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Regeneron Study Site

Antwerp, B-2060, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pozelimab

Drug

Single subcutaneous (SC) injection

Other names: REGN3918

Primary outcomes

  1. Assess the time of the last positive concentration (AUClast) pharmacokinetic (PK) profile of pozelimab in Process A

    Time frame: Up to 16 weeks

  2. Assess the time of the last positive concentration (AUClast) PK profile of pozelimab in Process B

    Time frame: Up to 16 weeks

  3. Assess peak concentration (Cmax) PK profile of pozelimabin in Process A

    Time frame: Up to 16 weeks

  4. Assess peak concentration (Cmax) PK profile of pozelimab in Process B

    Time frame: Up to 16 weeks

Secondary outcomes

  1. Incidence of treatment emergent adverse events (TEAEs)

    Time frame: Up to 16 weeks

  2. Incidence of anti-drug antibodies (ADA) to pozelimab over time

    Time frame: Up to 16 weeks

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 29, 2020
Registry last updated
Mar 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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