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A Randomized, Placebo-controlled, Double-blind, Single-ascending-dose and Multiple-ascending-dose, Phase 1 Study to Assess the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of IV NTR-441 Solution in HV Adults and COVID-19 Patients

Trial Profile

A Randomized, Placebo-controlled, Double-blind, Single-ascending-dose and Multiple-ascending-dose, Phase 1 Study to Assess the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of IV NTR-441 Solution in HV Adults and COVID-19 Patients

Status: Discontinued
Phase of Trial: Phase I

Latest Information Update: 24 Jan 2024

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At a glance

  • Drugs NTR 441 (Primary)
  • Indications Autoimmune disorders; COVID 2019 infections; Systemic lupus erythematosus
  • Focus Adverse reactions; First in man
  • Sponsors Neutrolis Therapeutics

Most Recent Events

  • 18 Jan 2024 Status changed from recruiting to discontinued because of insufficient enrollment due to emergence of omicron variant of COVID-19.
  • 27 Sep 2022 Planned End Date changed from 1 Jun 2022 to 1 Nov 2022.
  • 27 Sep 2022 Planned primary completion date changed from 1 Jun 2022 to 1 Nov 2022.

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