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
Study ID
NCT04940364
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Pozelimab — DRUG
    Administered intravenous (IV) or subcutaneous (SC) per protocol
  • Cemdisiran — DRUG
    Administered SC per protocol

Study Details

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

Key Dates

Start date
Aug 4, 2021
Status verified
Jun 2022
Primary completion
Jun 22, 2022
Completion
Jun 22, 2022

Study Design

Enrollment
30 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Pozelimab: Single-dose SC on day 1
  • Experimental: Cohort 2
    Pozelimab: Single-dose IV on day 1
  • Experimental: Cohort 3
    Pozelimab: Single-dose SC on day 29 Cemdisiran: Single-dose SC on day 1
  • Experimental: Cohort 4
    Pozelimab: Single-dose SC on day 1 Cemdisiran: Single-dose SC on day 1
  • Experimental: Cohort 5
    Optional Pozelimab: Single-dose SC on day 1 or day 29 Cemdisiran: Single-dose SC on day 1
  • Experimental: Cohort 6
    Pozelimab: Single-dose IV on day 1

Primary Outcome Measure

Concentrations of pozelimab in serum over time [ Time Frame: Up to 20 weeks ]

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