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

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT04601844
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Pozelimab — DRUG
    Single dose administered subcutaneously
  • Cemdisiran — DRUG
    Single dose administered SC

Study Details

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

Key Dates

Start date
Nov 16, 2020
Status verified
Nov 2021
Primary completion
Jul 23, 2021
Completion
Jul 23, 2021

Study Design

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

Arms

  • 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
  • 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
  • Experimental: Cohort 3
    Cemdisiran at dose 2 SC single dose and pozelimab at dose 2 SC single dose, both administered on day 1

Primary Outcome Measure

Incidence and severity of treatment emergent adverse events (TEAEs) [ Time Frame: Up to 20 weeks ]

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