Healthy VolunteerPhase 1NCT01418989
A Study of Administration of RoActemra/Actemra (Tocilizumab) by Auto-injector Vs. Pre-filled Syringe in Healthy Volunteers
A Phase 1 study testing tocilizumab [RoActemra/Actemra] Syringe and tocilizumab [RoActemra/Actemra] auto-injector in people with Healthy Volunteer, run by Hoffmann-La Roche at 2 sites in France.
Trial summary
This open-label, multi-center study will compare the bioavailability of RoActemra/Actemra (tocilizumab) administration by auto-injector versus pre-filled syringe in healthy volunteers. Healthy volunteers will receive a single dose of RoActemra/Actemra (tocilizumab). The anticipated time of study duration is 28 days. 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?
- tocilizumab [RoActemra/Actemra] Syringe and tocilizumab [RoActemra/Actemra] auto-injector
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 239 participants
- Where
- 2 sitesFrance
- Study dates
- Jul 2011to Nov 2011
- 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
- Healthy volunteers, age 18 to 65 years inclusive
- Intact normal skin without potentially obscuring tattoos, pigmentation, lesion in the area for intended injection
- A body mass index (BMI) between 18 to 32 kg/m2 inclusive
Who cannot join
- Volunteers with any known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections
- A history of clinically significant gastrointestinal, renal, hepatic, cardiovascular, or allergic disease
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: An Open-label, Multi-center Study to Compare the Relative Bioavailability of Tocilizumab in Healthy Subjects Following Single Dose Subcutaneous (SC) Administration Via Disposable Auto-Injector (DAI) Device vs Pre-filled Glass Syringe (PFS)
This open-label, multi-center study will compare the bioavailability of RoActemra/Actemra (tocilizumab) administration by auto-injector versus pre-filled syringe in healthy volunteers. Healthy volunteers will receive a single dose of RoActemra/Actemra (tocilizumab). The anticipated time of study duration is 28 days.
- Conditions
- Healthy Volunteer
- Being tested
- tocilizumab [RoActemra/Actemra] Syringe, tocilizumab [RoActemra/Actemra] auto-injector
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tocilizumab [RoActemra/Actemra] SyringeDrug
Single dose administration with pre-filled syringe
tocilizumab [RoActemra/Actemra] auto-injectorDrug
Single dose administration with auto-injector
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: tocilizumab [RoActemra/Actemra] auto-injector |
| 2 | Experimental | Not described Receives: Drug: tocilizumab [RoActemra/Actemra] Syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve (AUC) of RoActemra/Actemra
Measured: 21 days
Peak plasma concentration of RoActemra/Actemra
Measured: 21 days
Secondary outcomes (1)
Safety (Incidence of adverse events)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01418989
- Sponsor's protocol ID
- NP25539
- Status last verified
- Nov 2016
- First submitted
- 16 Aug 2011
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center Study to Compare the Relative Bioavailability of Tocilizumab in Healthy Subjects Following Single Dose Subcutaneous (SC) Administration Via Disposable Auto-Injector (DAI) Device vs Pre-filled Glass Syringe (PFS)
- ClinicalTrials.gov ID
- NCT01418989
- Acronym / sponsor ID
- NP25539
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 17 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This open-label, multi-center study will compare the bioavailability of RoActemra/Actemra (tocilizumab) administration by auto-injector versus pre-filled syringe in healthy volunteers. Healthy volunteers will receive a single dose of RoActemra/Actemra (tocilizumab). The anticipated time of study duration is 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: tocilizumab [RoActemra/Actemra] auto-injector |
| 2 | Experimental | Drug: tocilizumab [RoActemra/Actemra] Syringe |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy volunteers, age 18 to 65 years inclusive
- Intact normal skin without potentially obscuring tattoos, pigmentation, lesion in the area for intended injection
- A body mass index (BMI) between 18 to 32 kg/m2 inclusive
Key exclusion criteria (2 listed)
- Volunteers with any known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections
- A history of clinically significant gastrointestinal, renal, hepatic, cardiovascular, or allergic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tocilizumab [RoActemra/Actemra] SyringeSingle dose administration with pre-filled syringe | Drug | 2 |
| tocilizumab [RoActemra/Actemra] auto-injectorSingle dose administration with auto-injector | Drug | 1 |
Primary outcome
Area under the plasma concentration versus time curve (AUC) of RoActemra/Actemra
Time frame: 21 days
Peak plasma concentration of RoActemra/Actemra
Time frame: 21 days
1 secondary outcome
Safety (Incidence of adverse events)
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing tocilizumab [RoActemra/Actemra] Syringe and tocilizumab [RoActemra/Actemra] auto-injector in people with Healthy Volunteer, run by Hoffmann-La Roche at 2 sites in France.
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 3 inclusion and 2 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 2 sites in France. 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?
Area under the plasma concentration versus time curve (AUC) of RoActemra/Actemra (time frame: 21 days). 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?
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.