A Phase 1 Study to Compare the Safety and Effect of Efgartigimod as an Intravenous Infusion With the Effect of Efgartigimod as a Subcutaneous Injection in Healthy Volunteers

Sponsor
argenx
Study ID
NCT04564066
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • efgartigimod IV — BIOLOGICAL
    intravenous infusions of efgartigimod
  • efgartigimod PH20 SC — BIOLOGICAL
    subcutaneous injections of efgartigimod PH20 SC

Study Details

This study will compare the pharmacodynamics, pharmacokinetics and safety of efgartigimod as an intravenous infusion with efgartigimod as a subcutaneous injection in healthy adults.

Key Dates

Start date
Aug 18, 2020
Status verified
Mar 2021
Primary completion
Dec 24, 2020
Completion
Feb 11, 2021

Study Design

Enrollment
54 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: efgartigimod IV
    intravenous infusions of efgartigimod
  • Experimental: efgartigimod PH20 SC
    subcutaneous injections of efgartigimod PH20 SC

Primary Outcome Measure

Percentage reduction in total IgG levels, compared to baseline, at day 29 (week 4), 7 days after the fourth IV or SC administration of efgartigimod [ Time Frame: After four weeks (day 29) ]

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