*A Randomized, Double Blind, 3-arm, Parallel Study in Healthy Volunteers for BMab 1200

• Research type

  Research Study

• Full title

  A Phase 1, Randomized, Double-blind, 3-arm, Parallel Design Study in Healthy Subjects to Evaluate Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Bmab 1200 After Single Subcutaneous Injection inComparison with EU-approved Stelara® and US-licensed Stelara®

• IRAS ID

  1004851

• Contact name

  Amelia Gheorghisor

• Contact email

  fsp-sust-uk@fortrea.com

• Sponsor organisation

  Biocon Biologics UK Limited

• Eudract number

  2021-006630-39

• ISRCTN Number

  ISRCTN11424009

• Research summary

  This will be a Phase 1, randomized, double-blind (neither the subject nor the investigator know whether they receive placebo or active drug), 3-arm, parallel group study to establish similarity of blood levels after dose between Bmab 1200, US-licensed Stelara (US Stelara), and EU-approved Stelara (EU Stelara) after single 45 mg subcutaneous (under the skin) injection in healthy male and female Participants. Up to 258 participants will be enrolled to ensure that at least 246 participants complete the study. Potential participants will be screened to assess their eligibility to enter the study within 28 days prior to the dose administration. Participants will be admitted into the study site on Day -1 (the day before dosing) and be confined to the study site until discharge on Day 10. Participants will return to the study site for follow-up visits up to Day 113 (± 2 days). Participants will be randomized in 1:1:1 ratio to receive a single dose of 45 mg study drug on Day 1 as either:

  • US Stelara,
  • EU Stelara, or
  • Bmab 1200.

  Two cohorts of 3 participants (1 Bmab 1200, 1 US Stelara, and 1 EU Stelara per cohort) will be dosed at least 24 hours apart and, providing no safety concerns arise, remaining subjects will be dosed starting from at least 24 hours later. Safety data (including AEs, injection site reactions, 12-lead electrocardiogram (ECG), vital signs, and physical examinations as available) will be reviewed after each cohort and continuation to dose remaining participants will be at the investigator’s discretion.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  22/FT/0012

• Date of REC Opinion

  7 Apr 2022

• REC opinion

  Further Information Favourable Opinion