Clincosm LogoSign in Get a demo

A Study to Examine the Safety, Tolerability and Biological Effects of Single Doses of Subcutaneously and Intravenously Administered Pozelimab as Monotherapy and in Combination With Single Doses of Subcutaneously Administered Cemdisiran in Adult Japanese Healthy Volunteers

Sponsor
Regeneron Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT04940364
Collaborator
(none)
30
Enrollment
1
Location
6
Arms
10.6
Actual Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of the study is to assess the concentration-time profiles of total pozelimab, total C5, cemdisiran, and cemdisiran metabolite(s) in Japanese adult participants following single doses of intravenous (IV) and subcutaneous (SC) pozelimab and SC cemdisiran when administered on the same day or sequentially 28 days apart.

The secondary objectives of the study are:

  • To evaluate the safety and tolerability of pozelimab alone and in combination with cemdisiran in healthy Japanese adult participants

  • To assess the pharmacodynamic (PD) profile of pozelimab alone and in combination with cemdisiran in healthy Japanese adult participants

  • To assess the immunogenicity of pozelimab and cemdisiran in healthy Japanese adult participants

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label Parallel-Dose Study of the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Single Doses of Subcutaneously and Intravenously Administered Pozelimab as Monotherapy and in Combination With Single Doses of Subcutaneously Administered Cemdisiran in Japanese Healthy Volunteers
Actual Study Start Date :
Aug 4, 2021
Actual Primary Completion Date :
Jun 22, 2022
Actual Study Completion Date :
Jun 22, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort 1

Pozelimab: Single-dose SC on day 1

Drug: Pozelimab
Administered intravenous (IV) or subcutaneous (SC) per protocol
Other Names:
  • REGN3918

    		•
    Experimental: Cohort 2

    Pozelimab: Single-dose IV on day 1

    Drug: Pozelimab
    Administered intravenous (IV) or subcutaneous (SC) per protocol
    Other Names:
  • REGN3918

    		•
    Experimental: Cohort 3

    Pozelimab: Single-dose SC on day 29 Cemdisiran: Single-dose SC on day 1

    Drug: Pozelimab
    Administered intravenous (IV) or subcutaneous (SC) per protocol
    Other Names:
  • REGN3918

    • Drug: Cemdisiran
    Administered SC per protocol
    Other Names:
  • ALN-CC5

    		•
    Experimental: Cohort 4

    Pozelimab: Single-dose SC on day 1 Cemdisiran: Single-dose SC on day 1

    Drug: Pozelimab
    Administered intravenous (IV) or subcutaneous (SC) per protocol
    Other Names:
  • REGN3918

    • Drug: Cemdisiran
    Administered SC per protocol
    Other Names:
  • ALN-CC5

    		•
    Experimental: Cohort 5

    Optional Pozelimab: Single-dose SC on day 1 or day 29 Cemdisiran: Single-dose SC on day 1

    Drug: Pozelimab
    Administered intravenous (IV) or subcutaneous (SC) per protocol
    Other Names:
  • REGN3918

    • Drug: Cemdisiran
    Administered SC per protocol
    Other Names:
  • ALN-CC5

    		•
    Experimental: Cohort 6

    Pozelimab: Single-dose IV on day 1

    Drug: Pozelimab
    Administered intravenous (IV) or subcutaneous (SC) per protocol
    Other Names:
  • REGN3918

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Concentrations of pozelimab in serum over time [Up to 20 weeks]

    2. Concentrations of cemdisiran in plasma over time. [Up to 20 weeks]

    Secondary Outcome Measures

    1. The incidence and severity of treatment-emergent adverse events (TEAE) in subjects administered pozelimab with/without cemdisiran [Up to 20 weeks]

    2. Concentrations of total C5 in plasma over time [Up to 20 weeks]

    3. Change from baseline in CH50 over time [Up to 20 weeks]

    4. Incidence of treatment-emergent anti-drug antibodies (ADA) to pozelimab [Up to 20 weeks]

    5. Incidence of treatment-emergent ADA to cemdisiran [Up to 20 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Key Inclusion Criteria:

    1. Japanese participant must be:

    2. Be Japanese, born in Japan, and have both biologic parents and 4 biologic grandparents who are ethnically Japanese and born in Japan

    3. Have maintained a Japanese lifestyle, with no significant change since leaving Japan, including having access to Japanese food and adhering to a Japanese diet

    4. Living < 10 years outside of Japan

    5. Has a Body Mass Index (BMI) between 18 and 30 kg/m2 (inclusive) at screening visit

    6. Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and ECGs performed at screening and/or prior to administration of initial dose of study drug

    7. Is in good health based on laboratory safety testing obtained at the screening visit Note: Participant with suspected or confirmed Gilbert's disease can be enrolled in the study

    8. Willing to undergo vaccination against N. meningitidis unless participant has documentation of completed series of vaccinations within the past 2 years of the screening visit

    9. Must have two consecutive negative COVID-19 tests at least 48 hours apart and within 7 days prior to study drug administration Note: The test may be the point of care quantitative reverse transcriptase polymerase chain reaction (RT-qPCR) test or approved COVID-19 antigen test at the discretion of the investigator.

    Key Exclusion Criteria:

    1. History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease, as assessed by the investigator as defined in the protocol

    2. Presents any concern to the study investigator that might confound the results of the study or poses an additional risk to the participant by their participation in the study

    3. Hospitalization (>24 hour) for any reason within 30 days of the screening visit

    4. Has a confirmed positive drug test result at the screening visit and/or prior to enrollment; or a history of alcohol and/or drug abuse within a year prior to the screening visit

    5. Is positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb) at the screening visit

    6. Is positive for hepatitis C antibody and positive for qualitative (i.e., detected) hepatitis C virus (HCV) RNA test at the screening visit

    7. Within the previous 2 months of the screening visit has a history of bacterial, protozoal, viral or parasite infection (including COVID-19) and/or persistent chronic or active recurring infection which require treatment with antibiotics, antivirals, or antifungals

    8. Known or suspected COVID-19 disease at screening and/or prior to 1st dose administration

    NOTE: Other protocol-defined Inclusion and Exclusion criteria apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Regeneron Research Site London United Kingdom SE1 1YR

    Sponsors and Collaborators

    • Regeneron Pharmaceuticals

    Investigators

    • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Regeneron Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT04940364
    Other Study ID Numbers:
    • R3918-HV-20117
    • 2021-001794-23
    First Posted:
    Jun 25, 2021
    Last Update Posted:
    Jul 6, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jul 6, 2022