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A Phase 1 Open-Label Study to Assess the Tolerability, Safety, and Immunogenicity of Hyaluronidase-Facilitated Subcutaneous Immunoglobulin 20% in Healthy Adults.

Andras NagyKimberly DuffAlexander BauerFred OkonnehJuan Carlos RondonLeman YelZhaoyang Li
Published in: Journal of clinical immunology (2023)
fSCIG 20% was well-tolerated with a favorable safety profile in healthy adults. Future studies will evaluate fSCIG 20% in primary immunodeficiency diseases. Trial registration number (ClinicalTrials.gov): NCT05059977 (registered 28 September 2021).
Keyphrases
  • open label
  • phase iii
  • phase ii
  • clinical trial
  • study protocol
  • phase ii study
  • current status
  • randomized controlled trial
  • squamous cell carcinoma
  • case control