A Study to Evaluate the Bioequivalence of Tocilizumab Following Subcutaneous Administration Via an Autoinjector (AI 1000-G2) Versus a Pre-Filled Syringe in Healthy Volunteers

  • Healthy Volunteers
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Completed

This trial runs in
Country
  • United States
Trial Identifier:

NCT02678988 WA30003

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Trial Summary

      The study consists of an eligibility screening period, two study periods involving single doses of tocilizumab (TCZ) according to an open-label, randomized, two-period crossover design with an interval of 6 weeks between periods, and a 6 week follow-up period. Healthy participants will receive a single subcutaneous (SC) injection of TCZ via a pre-filled syringe-needle safety device (PFS-NSD) and a single injection via an autoinjector (AI). The total duration of the study is up to 16 weeks from screening to follow-up. After screening, eligible participants will be randomly assigned to one of the two possible treatment sequences (Sequence 1: AI-1000 G2 followed by PFS-NSD or Sequence 2: PFS-NSD followed by AI-1000 G2) and assigned to one of three injection sites (1: abdomen, 2: thigh, or 3: upper arm). All participant groups will receive a total of two TCZ administrations each.

      Hoffmann-La Roche Sponsor
      Phase 1 Phase
      NCT02678988, WA30003 Trial Identifier
      AI-1000 G2, PFS-NSD, Tocilizumab Treatments
      Healthy Volunteer Condition

      Eligibility Criteria

      All Gender
      ≥ 18 Years & ≤ 65 Years Age
      Accepts Healthy Volunteers Healthy Volunteers
      Inclusion Criteria
      • Male participants and their partners of child-bearing potential must be willing to use two effective contraceptive methods
      • Female participants must be either postmenopausal or surgically sterile
      • Intact normal skin in the area for intended injection
      • Body weight less than (<) 150 kilograms (kg)
      • Have no contraindications from the following: a detailed medical and surgical history, a complete physical examination, including vital signs, 12-lead electro cardio gram (ECG), hematology, blood chemistry, serology, and urinalysis
      Exclusion Criteria
      • Participants with any known active current or history of recurrent Infectious disease
      • Positive result on hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus-1 (HIV-1) and HIV-2 at screening
      • A history of clinically significant gastrointestinal, renal, hepatic, cardiovascular, or allergic disease
      • Evidence of malignant disease, or malignancies diagnosed within the previous 5 years
      • Use of or being dependent within the last 12 months on any substances of abuse, including a relevant past history of alcohol abuse
      • Participants with a history of, or currently active primary or secondary immunodeficiency
      • Participants who smoke more than 10 cigarettes per day or equivalent in tobacco
      • Clinically relevant deviation from normal in the physical examination, including vital signs
      • Clinically relevant ECG abnormalities on screening
      • Evidence of atrial fibrillation, atrial flutter, right or left bundle branch block, Wolf-Parkinson-White syndrome, or cardiac pacemaker or any other significant cardiac abnormalities
      • Known allergy to TCZ or any other ingredient in the subcutaneous (SC) formulation
      • History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
      • Known coagulopathy
      • Clinically significant abnormalities in laboratory test results
      • Immunization with a live or attenuated vaccine is prohibited within 4 weeks prior to study drug administration

      For the latest version of this information please go to www.forpatients.roche.com

       

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