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A Phase I, randomized, double-blind, three-arm, parallel-design study in healthy subjects to evaluate pharmacokinetics, safety, tolerability, and immunogenicity of Bmab 1200 after a single subcutaneous injection in comparison with EU-approved Stelara and US-licensed Stelara

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Trial Profile

A Phase I, randomized, double-blind, three-arm, parallel-design study in healthy subjects to evaluate pharmacokinetics, safety, tolerability, and immunogenicity of Bmab 1200 after a single subcutaneous injection in comparison with EU-approved Stelara and US-licensed Stelara

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 26 May 2025

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At a glance

  • Drugs Ustekinumab (Primary) ; Ustekinumab (Primary)
  • Indications Atopic dermatitis; Brain cancer; Breast cancer; Cervical cancer; Colorectal cancer; Crohn's disease; Dermatomyositis; Fallopian tube cancer; Glioblastoma; Non-small cell lung cancer; Ovarian cancer; Peritoneal cancer; Plaque psoriasis; Polymyositis; Psoriatic arthritis; Renal cancer; Renal cell carcinoma; Spondylarthritis; Ulcerative colitis; Vasculitis
  • Focus Pharmacokinetics
  • Sponsors Biocon

Most Recent Events

  • 18 Feb 2025 According to Biocon biologics media release, company announced today that the European Commission (EC) granted marketing authorisation in the European Union (EU) for YESINTEK, a biosimilar of Ustekinumab.
  • 02 Feb 2023 Status changed from not yet recruiting to completed.
  • 15 Apr 2022 New trial record

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