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A Phase 1, Single Center, Randomized, Double-Blind, Placebo-Controlled, Single (Part 1) and Multiple (Part 2) Ascending Dose Study to Evaluate the Safety, Tolerability, PK and PD of M281 Administered to Healthy Volunteers

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Trial Profile

A Phase 1, Single Center, Randomized, Double-Blind, Placebo-Controlled, Single (Part 1) and Multiple (Part 2) Ascending Dose Study to Evaluate the Safety, Tolerability, PK and PD of M281 Administered to Healthy Volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 01 Jun 2022

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At a glance

  • Drugs Nipocalimab (Primary)
  • Indications Autoimmune disorders; Autoimmune haemolytic anaemia; Haemolytic disease of newborn; Myasthenia gravis; Rheumatoid arthritis; Sjogren's syndrome; Systemic lupus erythematosus
  • Focus Adverse reactions; First in man
  • Sponsors Momenta Pharmaceuticals

    • Most Recent Events

    • 26 Apr 2022 Results from NCT02828046, NCT03772587 evaluating effect of nipocalimab on immune function, presented at the 74th Annual Meeting of the American Academy of Neurology 2022
    • 06 Nov 2018 Results published in the Clinical Pharmacology and Therapeutics
    • 04 Oct 2018 According to a Momenta Pharmaceuticals media release, data from this trial will be presented in a webcast of the companys R and D Day on Thursday (11 Oct 2018).

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