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A randomized, placebo-controlled, double-blind, single-dose, dose escalation phase 1b study of lenzilumab in healthy Korean adults

Trial Profile

A randomized, placebo-controlled, double-blind, single-dose, dose escalation phase 1b study of lenzilumab in healthy Korean adults

Status: Planning
Phase of Trial: Phase I

Latest Information Update: 27 Jul 2021

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At a glance

  • Drugs Lenzilumab (Primary)
  • Indications COVID 2019 infections
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Telcon RF Pharmaceutical
  • Most Recent Events

    • 27 Jul 2021 New trial record
    • 22 Jul 2021 According to a Humanigen media release, compny plan to apply to MFDS for conditional approval for importation of lenzilumab for use in Korea. Support for conditional approval would be based on data from this phase 1 study and the existing data from Phase 3 LIVE-AIR study. Additional clinical trials are not expected to be necessary in this situation.
    • 22 Jul 2021 According to a Humanigen media release, Telcon RF Pharmaceutical, Inc. (Telcon) and KPM Tech Co., Ltd. (KPM Tech), have received approval from South Korea MFDS (the South Korean equivalent of the U.S. FDA) to conduct this trial.
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