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Completed

NCT Number: NCT02678988

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

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.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Lenexa, Kansas, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AI-1000 G2

Device

The device will contain TCZ (180 milligrams per milliliter [mg/mL]) SC formulation single dose of 0.9 mL that corresponds to 162 mg TCZ administered via PFS and assembled in the AI (AI-1000 G2).

PFS-NSD

Device

The device will contain TCZ (180 mg/mL) SC formulation single dose of 0.9 mL that corresponds to 162 mg TCZ administered via PFS-NSD.

Tocilizumab

Drug

Participants will receive two single doses of 162 mg tocilizumab SC on Day 1 (Period 1) and Day 43 (Period 2), with a washout period of 6 weeks between the periods.

Other names: RO4877533; Actemra/RoActemra

Primary outcomes

  1. Maximum observed serum concentration (Cmax) of TCZ

    Time frame: Pre-dose and 8 hours post-dose on Day 1, and pre-dose on Days 2, 3, 4, 5, 6, 8, 10, 13, 16, 19, 22, 29, 36, pre-dose and 8 hours post-dose on Day 43, and pre-dose on Days 44, 45, 46, 47, 48, 50, 52, 55, 58, 61, 64, 71, 78 and 85

  2. Area under the serum concentration-time curve from time zero to last quantifiable concentration (AUClast) of TCZ

    Time frame: Pre-dose and 8 hours post-dose on Day 1, and pre-dose on Days 2, 3, 4, 5, 6, 8, 10, 13, 16, 19, 22, 29, 36, pre-dose and 8 hours post-dose on Day 43, and pre-dose on Days 44, 45, 46, 47, 48, 50, 52, 55, 58, 61, 64, 71, 78 and 85

Secondary outcomes

  1. Area under the serum concentration-time curve from time zero to extrapolated infinite time [AUC (0-inf)] of TCZ

    Time frame: Pre-dose and 8 hours post-dose on Day 1, and pre-dose on Days 2, 3, 4, 5, 6, 8, 10, 13, 16, 19, 22, 29, 36, pre-dose and 8 hours post-dose on Day 43, and pre-dose on Days 44, 45, 46, 47, 48, 50, 52, 55, 58, 61, 64, 71, 78 and 85

  2. Time to reach maximum observed serum concentration (Tmax) of TCZ

    Time frame: Pre-dose and 8 hours post-dose on Day 1, and pre-dose on Days 2, 3, 4, 5, 6, 8, 10, 13, 16, 19, 22, 29, 36, pre-dose and 8 hours post-dose on Day 43, and pre-dose on Days 44, 45, 46, 47, 48, 50, 52, 55, 58, 61, 64, 71, 78 and 85

  3. Apparent elimination rate constant (Kel) of TCZ

    Time frame: Pre-dose and 8 hours post-dose on Day 1, and pre-dose on Days 2, 3, 4, 5, 6, 8, 10, 13, 16, 19, 22, 29, 36, pre-dose and 8 hours post-dose on Day 43, and pre-dose on Days 44, 45, 46, 47, 48, 50, 52, 55, 58, 61, 64, 71, 78 and 85

  4. Number of participants with adverse events

    Time frame: Baseline up to 8 weeks after the last dose of study drug (approximately 7 months)

  5. Number of participants with anti-drug antibody (ADA) response

    Time frame: Pre-dose on Days 1 and 43, and Day 85

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 10, 2016
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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