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A Phase 1, Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of CT-P17 and Humira (US-licensed Humira and EU-approved Humira) in Healthy Subjects

Trial Profile

A Phase 1, Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of CT-P17 and Humira (US-licensed Humira and EU-approved Humira) in Healthy Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 15 Dec 2020

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At a glance

  • Drugs Adalimumab (Primary)
  • Indications Rheumatoid arthritis
  • Focus First in man; Pharmacokinetics
  • Sponsors Celltrion

Most Recent Events

  • 10 Dec 2020 According to a Celltrion media release, the ECs decision would broaden treatment alternatives for patients suffering from rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), axial spondyloarthritis (AS), psoriatic arthritis (PsA), psoriasis (Ps), paediatric plaque psoriasis (pPs), hidradenitis suppurativa (HS), Crohns disease (CD), paediatric Crohns disease (pCD), ulcerative colitis (UC), uveitis (UV) and paediatric uveitis (pUV).
  • 10 Dec 2020 According to a Celltrion media release, the CHMP positive opinion will now be reviewed by the European Commission (EC). The ECs decision regarding approval is expected in the first quarter of 2021.
  • 10 Dec 2020 According to a Celltrion media release, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the marketing authorisation of an adalimumab biosimilar candidate referencing Humira, CT-P17 recommending approval for all available indications.This positive opinion is based on the clinical data from the phase I and III studies (NCT03970824 and NCT03789292).The CHMP positive opinion will now be reviewed by the EC.

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