HealthyPhase 1NCT02806219
Open-label, Bioequivalence Study of Certolizumab Pegol 200 mg Solution Injected Either by a Prefilled Syringe (Reference) or by an E-Device (Test) in Healthy Subjects
A Phase 1 study testing Prefilled syringe (PFS) and e-Device in people with Healthy, run by UCB BIOSCIENCES, Inc. at 1 site in United States.
Trial summary
This is a single center, open-label, Phase 1 bioequivalence (BE) study in healthy subjects designed to demonstrate the bioequivalence of a single dose of certolizumab pegol (CZP) 200mg when injected by means of a prefilled syringe (PFS, reference) or injected by means of a injection device (e-Device, test). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Prefilled syringe (PFS) and e-Device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Nov 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is male or female and between 18 and 55 years of age at Screening.
- Subject is in good physical and mental health status determined on the basis of the medical history and a general clinical examination.
- Subject has no evidence of active or inactive Tuberculosis (TB).
- Female subjects of childbearing potential should have a negative pregnancy test at study entry and should be using a medically accepted method of contraception during the entire duration of the study and for 10 weeks after the final dose of CZP.
- Female subjects who are postmenopausal for at least 2 years and have a serum follicle stimulating hormone (FSH) level >40mIU/mL at the Screening Visit, or have undergone a hysterectomy, bilateral tubal ligation, and/or bilateral ovariectomy, or have a congenital sterility are considered not of childbearing potential.
Who cannot join
- Subject receiving any live (includes attenuated) vaccination or immunoglobulins within 56 days preceding the CZP injection.
- Subject has taken any drugs (including over-the-counter medications) within 56 days preceding the CZP injection (with the exception of those noted in Section 7.8.1.).
- Subject is known to be intolerant to pegol.
- Subject has previously received CZP.
- Subject has received TNFα-inhibitors within 12 months or other biologic within 6 months before randomization into the study.
- Subject has an active or chronic/latent infection including TB, hepatitis C virus (HCV), hepatitis B core antigen (HBc), or human immunodeficiency virus (HIV).-- Subject has symptomatic herpes zoster infection (shingles) within 6 months prior to Screening.
- Subject has chronic, serious, opportunistic recurring infection or condition within 6 months prior to Screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label, Single-center, Randomized, Parallel Group, Single-dose, Bioequivalence Study of Certolizumab Pegol 200 mg Solution Injected Either by a Prefilled Syringe (Reference) or by an E-Device (Test) in Healthy Subjects
This is a single center, open-label, Phase 1 bioequivalence (BE) study in healthy subjects designed to demonstrate the bioequivalence of a single dose of certolizumab pegol (CZP) 200mg when injected by means of a prefilled syringe (PFS, reference) or injected by means of a injection device (e-Device, test).
- Conditions
- Healthy
- Being tested
- Prefilled syringe (PFS), e-Device
- Keywords
- Bioequivalence, Certolizumab pegol, Human Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prefilled syringe (PFS)Device
Active substance: Certolizumab Pegol Pharmaceutical form: Solution for injection Administration: By prefilled syringe (PFS)
e-DeviceDevice
Active substance: Certolizumab Pegol Pharmaceutical form: Solution for injection Administration: By e-Device
| Study group | Role | What they receive |
|---|---|---|
| Certolizumab Pegol injection by prefilled syringe | Active comparator | Not described Receives: Device: Prefilled syringe (PFS) |
| Certolizumab Pegol injection by e-Device | Experimental | Not described Receives: Device: e-Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax)
Measured: Predose on Day 1 and at 12 hours postdose, and on days 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, 70.
Area under the CZP plasma concentration-time curve from time 0 to infinity (AUC)
Measured: Predose on Day 1 and at 12 hours postdose, and on days 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, 70.
Area under the CZP plasma concentration-time curve from time 0 to last observed quantifiable concentration (AUC(0-t))
Measured: Predose on Day 1 and at 12 hours postdose, and on days 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, 70.
Secondary outcomes (4)
Time of observed Cmax (tmax)
Measured: Predose on Day 1 and at 12 hours postdose, and on days 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, 70.
Terminal elimination half-life (t1/2)
Measured: Predose on Day 1 and at 12 hours postdose, and on days 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, 70.
Apparent total body clearance (CL/F)
Measured: Predose on Day 1 and at 12 hours postdose, and on days 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, 70.
Apparent volume of distribution (Vz/F)
Measured: Predose on Day 1 and at 12 hours postdose, and on days 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, 70.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study startMar 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB BIOSCIENCES, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, UCB Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02806219
- Sponsor's protocol ID
- RA0132
- Status last verified
- Nov 2016
- First submitted
- 15 Jun 2016
- Last updated
- 17 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Single-center, Randomized, Parallel Group, Single-dose, Bioequivalence Study of Certolizumab Pegol 200 mg Solution Injected Either by a Prefilled Syringe (Reference) or by an E-Device (Test) in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02806219
- Acronym / sponsor ID
- RA0132
- Conditions
- Healthy
- Keywords
- Bioequivalence, Certolizumab pegol, Human Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- UCB BIOSCIENCES, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- Mar 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 20 Jun 2016 (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 is a single center, open-label, Phase 1 bioequivalence (BE) study in healthy subjects designed to demonstrate the bioequivalence of a single dose of certolizumab pegol (CZP) 200mg when injected by means of a prefilled syringe (PFS, reference) or injected by means of a injection device (e-Device, test).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Certolizumab Pegol injection by prefilled syringe | Active comparator | Device: Prefilled syringe (PFS) |
| Certolizumab Pegol injection by e-Device | Experimental | Device: e-Device |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subject is male or female and between 18 and 55 years of age at Screening.
- Subject is in good physical and mental health status determined on the basis of the medical history and a general clinical examination.
- Subject has no evidence of active or inactive Tuberculosis (TB).
- Female subjects of childbearing potential should have a negative pregnancy test at study entry and should be using a medically accepted method of contraception during the entire duration of the study and for 10 weeks after the final dose of CZP.
- Female subjects who are postmenopausal for at least 2 years and have a serum follicle stimulating hormone (FSH) level >40mIU/mL at the Screening Visit, or have undergone a hysterectomy, bilateral tubal ligation, and/or bilateral ovariectomy, or have a congenital sterility are considered not of childbearing potential.
Key exclusion criteria (7 listed)
- Subject receiving any live (includes attenuated) vaccination or immunoglobulins within 56 days preceding the CZP injection.
- Subject has taken any drugs (including over-the-counter medications) within 56 days preceding the CZP injection (with the exception of those noted in Section 7.8.1.).
- Subject is known to be intolerant to pegol.
- Subject has previously received CZP.
- Subject has received TNFα-inhibitors within 12 months or other biologic within 6 months before randomization into the study.
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 |
|---|---|---|
| Prefilled syringe (PFS)Active substance: Certolizumab Pegol Pharmaceutical form: Solution for injection Administration: By prefilled syringe (PFS) | Device | Certolizumab Pegol injection by prefilled syringe |
| e-DeviceActive substance: Certolizumab Pegol Pharmaceutical form: Solution for injection Administration: By e-Device | Device | Certolizumab Pegol injection by e-Device |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: Predose on Day 1 and at 12 hours postdose, and on days 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, 70.
Area under the CZP plasma concentration-time curve from time 0 to infinity (AUC)
Time frame: Predose on Day 1 and at 12 hours postdose, and on days 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, 70.
Area under the CZP plasma concentration-time curve from time 0 to last observed quantifiable concentration (AUC(0-t))
Time frame: Predose on Day 1 and at 12 hours postdose, and on days 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, 70.
4 secondary outcomes
Time of observed Cmax (tmax)
Time frame: Predose on Day 1 and at 12 hours postdose, and on days 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, 70.
Terminal elimination half-life (t1/2)
Time frame: Predose on Day 1 and at 12 hours postdose, and on days 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, 70.
Apparent total body clearance (CL/F)
Time frame: Predose on Day 1 and at 12 hours postdose, and on days 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, 70.
Apparent volume of distribution (Vz/F)
Time frame: Predose on Day 1 and at 12 hours postdose, and on days 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, 70.
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 17 Nov 2016.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
UCB Cares study director
UCB Pharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Prefilled syringe (PFS) and e-Device in people with Healthy, run by UCB BIOSCIENCES, Inc. at 1 site 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 7 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 17 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 1 site 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 plasma concentration (Cmax) (time frame: Predose on Day 1 and at 12 hours postdose, and on days 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, 70.). The study lists 3 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 17 Nov 2016.