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Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Pozelimab in Combination With Cemdisiran in Healthy Adult Volunteers

Sponsor
Regeneron Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT04601844
Collaborator
Alnylam Pharmaceuticals (Industry)
19
Enrollment
1
Location
3
Arms
8.2
Actual Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of the study is to evaluate the safety and tolerability of ascending doses of 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 assess the concentration-time profiles of total pozelimab, total complement component 5 (C5), cemdisiran, and cemdisiran metabolite(s) following single ascending doses of SC pozelimab and SC cemdisiran when administered on the same day or sequentially 28 days apart

  • To assess the pharmacodynamic (PD) profile of ascending doses of SC pozelimab and SC cemdisiran, as well as when administered on the same day or sequentially 28 days apart

  • To assess the immunogenicity of pozelimab and cemdisiran

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label, Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Doses of Subcutaneously Administered Human Monoclonal Antibody Pozelimab in Combination With Single Doses of Subcutaneously Administered siRNA Cemdisiran in Healthy Volunteers
Actual Study Start Date :
Nov 16, 2020
Actual Primary Completion Date :
Jul 23, 2021
Actual Study Completion Date :
Jul 23, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort 1

Cemdisiran at dose 1 SC single dose on day 1 followed by pozelimab at dose 1 SC single dose on day 29

Drug: Pozelimab
Single dose administered subcutaneously
Other Names:
  • REGN3918

    • Drug: Cemdisiran
    Single dose administered SC
    Other Names:
  • ALN-CC5

    		•
    Experimental: Cohort 2

    Cemdisiran at dose 2 SC single dose on day 1 followed by pozelimab at dose 1 SC single dose on day 29

    Drug: Pozelimab
    Single dose administered subcutaneously
    Other Names:
  • REGN3918

    • Drug: Cemdisiran
    Single dose administered SC
    Other Names:
  • ALN-CC5

    		•
    Experimental: Cohort 3

    Cemdisiran at dose 2 SC single dose and pozelimab at dose 2 SC single dose, both administered on day 1

    Drug: Pozelimab
    Single dose administered subcutaneously
    Other Names:
  • REGN3918

    • Drug: Cemdisiran
    Single dose administered SC
    Other Names:
  • ALN-CC5

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence and severity of treatment emergent adverse events (TEAEs) [Up to 20 weeks]

    Secondary 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]

    3. Concentrations of total C5 over time [Up to 20 weeks]

    4. Change from baseline in total complement hemolytic activity assay (CH50) over time [Up to 20 weeks]

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

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Key Inclusion Criteria:

    1. Has a body mass index less than 30 kg/m2 at the screening visit

    2. Judged to be in good health as defined in the protocol

    3. 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

    4. Willing to undergo vaccination against Neisseria meningitidis unless subjects have documentation of completed series of vaccinations within the past 2 years of the screening visit

    5. Must have two negative COVID-19 tests taken 48 hours apart and within 7 days prior to study drug administration

    Key Exclusion Criteria:

    1. History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease, as assessed by the investigator that may confound the results of the study or poses an additional risk to the subject by study participation

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

    3. Has a confirmed positive drug test result at the screening visit and/or prior to enrollment; or a history of recreational drug use (eg, marijuana) and/or drug or alcohol abuse within a year prior to the screening visit

    4. Is positive for HIV, hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb), hepatitis C antibody and positive for qualitative (ie, detected) HCV RNA test at the screening visit

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

    6. Known or suspected COVID-19 disease

    7. Known allergy or intolerance to penicillin class antibiotics or macrolides

    NOTE: Other protocol-defined Inclusion/ Exclusion criteria apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Regeneron Research Site Antwerp Belgium B-2060

    Sponsors and Collaborators

    • Regeneron Pharmaceuticals
    • Alnylam 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:
    NCT04601844
    Other Study ID Numbers:
    • R3918-HV-1982
    • 2020-000300-11
    First Posted:
    Oct 26, 2020
    Last Update Posted:
    Nov 12, 2021
    Last Verified:
    Nov 1, 2021
    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 Nov 12, 2021