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Healthy VolunteerPhase 1NCT02678988

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

A Phase 1 study testing AI-1000 G2, PFS-NSD and Tocilizumab in people with Healthy Volunteer, run by Hoffmann-La Roche at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteer
What is being tested?
AI-1000 G2, PFS-NSD and Tocilizumab
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
189 participants
Where
3 sitesUnited States
Study dates
Feb 2016to Jun 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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 locations and contacts

3 sites in 1 country.

United States3 sites

  • Study site

    Lenexa, Kansas, 66219

  • Study site

    Marlton, New Jersey, 08053

  • Study site

    Salt Lake City, Utah, 84106

Other trials in United States

About this study

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.

Being tested
AI-1000 G2, PFS-NSD, Tocilizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AI-1000 G2Device

    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-NSDDevice

    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.

  • TocilizumabDrug

    Also called RO4877533; Actemra/RoActemra

    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.

Study groups in NCT02678988
Study groupRoleWhat they receive
A1: Tocilizumab AI followed by PFS-NSD in abdomenExperimentalParticipants 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.
Receives: Device: AI-1000 G2; Device: PFS-NSD; Drug: Tocilizumab
A2: Tocilizumab AI followed by PFS-NSD in thighExperimentalParticipants 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.
Receives: Device: AI-1000 G2; Device: PFS-NSD; Drug: Tocilizumab
A3: Tocilizumab AI followed by PFS-NSD in upper armExperimentalParticipants 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.
Receives: Device: AI-1000 G2; Device: PFS-NSD; Drug: Tocilizumab
B1: Tocilizumab PFS-NSD followed by AI in abdomenExperimentalParticipants 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.
Receives: Device: AI-1000 G2; Device: PFS-NSD; Drug: Tocilizumab
B2: Tocilizumab PFS-NSD followed by AI in thighExperimentalParticipants 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.
Receives: Device: AI-1000 G2; Device: PFS-NSD; Drug: Tocilizumab
B3: Tocilizumab PFS-NSD followed by AI in upper armExperimentalParticipants 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.
Receives: Device: AI-1000 G2; Device: PFS-NSD; Drug: Tocilizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum observed serum concentration (Cmax) of TCZ

    Measured: 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

    Measured: 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 (5)

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2016 (estimated)
  2. Study startFeb 2016
  3. Primary completionJun 2016
  4. Study completionJun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
189 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02678988
Sponsor's protocol ID
WA30003
Status last verified
Nov 2016
First submitted
8 Feb 2016
Last updated
2 Nov 2016
Results posted
No

Publications

  • Fettner S, Mela C, Wildenhahn F, Tavanti M, Wells C, Douglass W, Mallalieu NL. Evidence of bioequivalence and positive patient user handling of a tocilizumab autoinjector. Expert Opin Drug Deliv. 2019 May;16(5):551-561. doi: 10.1080/17425247.2019.1604678. Epub 2019 May 2.

    PubMed 31043095

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AI-1000 G2, PFS-NSD and Tocilizumab in people with Healthy Volunteer, run by Hoffmann-La Roche at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02678988, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.

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