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

Roche logo

Roche

Status and phase

Completed
Phase 1

Conditions

Healthy Volunteer

Treatments

Device: AI-1000 G2
Device: PFS-NSD
Drug: Tocilizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT02678988
WA30003

Details and patient eligibility

About

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.

Enrollment

189 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

189 participants in 6 patient groups

A1: Tocilizumab AI followed by PFS-NSD in abdomen
Experimental group
Description:
Participants will receive two single doses of 162 milligrams (mg) tocilizumab SC, first dose via AI on Day 1 (Period 1) followed by a washout period of 6 weeks, thereafter second dose via PFS-NSD on Day 43 (Period 2), in abdomen.
Treatment:
Drug: Tocilizumab
Device: PFS-NSD
Device: AI-1000 G2
A2: Tocilizumab AI followed by PFS-NSD in thigh
Experimental group
Description:
Participants will receive two single doses of 162 mg tocilizumab SC, first dose via AI on Day 1 (Period 1) followed by a washout period of 6 weeks, thereafter second dose via PFS-NSD on Day 43 (Period 2) in thigh.
Treatment:
Drug: Tocilizumab
Device: PFS-NSD
Device: AI-1000 G2
A3: Tocilizumab AI followed by PFS-NSD in upper arm
Experimental group
Description:
Participants will receive two single doses of 162 mg tocilizumab SC, first dose via AI on Day 1 (Period 1) followed by a washout period of 6 weeks, thereafter second dose via PFS-NSD on Day 43 (Period 2), in upper arm.
Treatment:
Drug: Tocilizumab
Device: PFS-NSD
Device: AI-1000 G2
B1: Tocilizumab PFS-NSD followed by AI in abdomen
Experimental group
Description:
Participants will receive two single doses of 162 mg tocilizumab SC, first dose via PFS-NSD on Day 1 (Period 1) followed by a washout period of 6 weeks, thereafter second dose via AI on Day 43 (Period 2), in abdomen.
Treatment:
Drug: Tocilizumab
Device: PFS-NSD
Device: AI-1000 G2
B2: Tocilizumab PFS-NSD followed by AI in thigh
Experimental group
Description:
Participants will receive two single doses of 162 mg tocilizumab SC, first dose via PFS-NSD on Day 1 (Period 1) followed by a washout period of 6 weeks, thereafter second dose via AI on Day 43 (Period 2), in thigh.
Treatment:
Drug: Tocilizumab
Device: PFS-NSD
Device: AI-1000 G2
B3: Tocilizumab PFS-NSD followed by AI in upper arm
Experimental group
Description:
Participants will receive two single doses of 162 mg tocilizumab SC, first dose via PFS-NSD on Day 1 (Period 1) followed by a washout period of 6 weeks, thereafter second dose via AI on Day 43 (Period 2), in thigh.
Treatment:
Drug: Tocilizumab
Device: PFS-NSD
Device: AI-1000 G2

Trial contacts and locations

3

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems