Healthy SubjectsPhase 1NCT02365948
A Study of Certolizumab Pegol to Evaluate Pharmacokinetics and Safety in Adult Healthy Chinese Subjects
A Phase 1 study testing Certolizumab Pegol in people with Healthy Subjects, run by UCB Pharma SA at 1 site in China.
Trial summary
This study will characterize the pharmacokinetics (PK) of certolizumab pegol (CZP) and evaluate safety of CZP in healthy Chinese subjects. 36 subjects will be randomized to receive one of 3 dose levels of CZP or placebo. The total study duration will be approximately 71-94 days for each subject. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Certolizumab Pegol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- Mar 2015to Aug 2015
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- An Institutional Review Board (IRB) / Independent Ethics Committee (IEC) approved written Informed Consent Form (ICF) is signed and dated by the subject
- Subject is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule or medication intake according to the judgment of the investigator
- Subject is male or female between 18 and 45 years of age, inclusive
- Results of clinical laboratory tests within the reference range of the laboratory or outside the reference range of the laboratory but considered as nonclinically significant by the investigator. This is not allowed for aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) and bilirubin values above the upper limit of normal (ULN) ranges
- Have a body weight of 50 to 80 kg and a body mass index (BMI) between 19 and 24 kg/m^2
- In good health as determined by the investigator on the basis of medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG) and results of laboratory tests during the Pretreatment Period (Screening and Baseline)
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- Nonsmoker and former smoker who have given up smoking more than 6 months before first administration
- Willing to abstain from alcohol-, tobacco- and caffeine-containing products for 48 hours prior to admission into the clinic and during the entire in-clinic stay
- Subjects should be a registered permanent Citizen of the People's Republic of China and are Chinese as evidenced by all 4 grandparents as Chinese by ethnical definition
- Female subjects of childbearing potential should have negative pregnancy test at Screening and at Baseline (Day -1) and should use a medically accepted method of contraception (one barrier method and including another - ie, hormonal contraception for at least 2 cycles, intrauterine device, implant device, diaphragm with spermicide, monogamous relationship with vasectomized [for at least 3 months] partner or using condoms with spermicide gel) during the entire duration of the study
Who cannot join
- Active malignancies or a history of malignancy, excluding basal cell carcinoma of the skin that had been excised prior to study start
- History of adverse reaction to polyethylene glycol
- History of severe or multiple allergies
- Known Tuberculosis (TB) disease, high risk of acquiring TB infection, or latent TB infection
- A history of chronic infection, recent serious or life-threatening infection (within 6 months, including herpes zoster), or a current sign or symptom that may indicated an infection
- Subject with a history or active systemic / respiratory infection due to fungal, parasitic, or mycotic pathogens including but not limited to histoplasmosis, coccidiosis, paracoccidiosis, pneumocystis, blastomyces, aspergillus, and nontuberculous mycobacteria
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- History of an infected joint prosthesis at any time with prosthesis still in situ
- Positive hepatitis B surface antigen, hepatitis C Virus immunoglobulin G (HCV IgG), or Human Immunodeficiency Virus (HIV) test result during the Screening
- Subject with blood pressure and pulse rate (measured in supine position, after 10 minutes rest) outside the normal range
- A mean corrected QT interval using Bazett's formula (QTcB) interval >450 ms at Screening. If the mean QTcB exceeds the limits above, one additional triplicate electrocardiogram (ECG) may be taken. If this triplicate also gives an abnormal result, the subject should be excluded
- Any history or evidence of any clinically significant (CS) cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy, or any other CS abnormality, as judged by the investigator
- History of substance abuse, drug addiction or alcoholism within 3 years prior to Screening
- Inability to abstain from smoking during the in-clinic stay
- Subject has made a blood donation or had a comparable blood loss (>350 mL) within the last 3 months prior to first intake of study drug
- Positive result of alcohol test or urine drug Screen
- Receiving any other Investigational Medicinal Product (IMP) within 3 months or 5 half-lives of it, whichever is longer, prior to the first dose of IMP or is scheduled to receive an IMP other than CZP during the course of the study
- Previous exposure to or has participated in studies with any other anti-TNFα antibody (Ab) compounds
- Use of any medication, prescription or over-the-counter within 14 days or 5 half-lives of the medication, whichever is longer, before the first dose of IMP, or it is anticipated to need any medication during the study
- Has been on herb medication during the last 2 weeks prior to screening, or is currently taking it
- Excessive use of caffeine-containing beverages exceeding 500 mg caffeine/day (5 cups of coffee)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Single Escalating Dose Study of Subcutaneous Certolizumab Pegol (CZP) to Evaluate the Pharmacokinetics and Safety of CZP in Healthy Chinese Subjects
This study will characterize the pharmacokinetics (PK) of certolizumab pegol (CZP) and evaluate safety of CZP in healthy Chinese subjects. 36 subjects will be randomized to receive one of 3 dose levels of CZP or placebo. The total study duration will be approximately 71-94 days for each subject.
Read the detailed description
This is a Phase 1, randomized, double-blind, placebo-controlled, single-center, single escalating dose study in healthy Chinese subjects. The primary objective of the study is to characterize the pharmacokinetics (PK) of certolizumab pegol (CZP) in healthy Chinese subjects after a single subcutaneous (sc) dose. The secondary objective is to evaluate safety of CZP in healthy Chinese subjects after a single sc dose. 36 healthy Chinese subjects (18 male and 18 female) will be randomized to receive one of 3 dose levels of CZP (100 mg, 200 mg and 400 mg) or placebo given by sc injections. Each dose group begins treatment staggered by a minimum of 14 days. The total duration of the study will be approximately 71 to 94 days for each subject. This includes a 2 to 21 days Screening Period, 1 day of treatment and 70 days Observation Period after administration of a single dose of investigational medicinal product.
- Conditions
- Healthy Subjects
- Being tested
- Certolizumab Pegol, Placebo
- Keywords
- Pharmacokinetics, Certolizumab Pegol, Healthy Chinese subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Certolizumab PegolBiological
Also called Cimzia, CDP870, CZP
- Active Substance: Certolizumab Pegol
- Pharmaceutical Form: Prefilled syringes
- Concentration: 200 mg/mL
- Route of Administration: Subcutaneous injection
PlaceboOther
Also called PBO
- Active Substance: Placebo
- Pharmaceutical Form: Prefilled syringes
- Concentration: 0.9 % Saline
- Route of Administration: Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Certolizumab Pegol 100 mg | Experimental | Subjects will receive100 mg of CZP given by subcutaneous injections in healthy Chinese subjects. The dose group begins treatment on Day 1.
To achieve an injectable CZP 100 mg dose, a manual process will be applied by the unblinded site pharmacist. Receives: Biological: Certolizumab Pegol; Other: Placebo |
| Certolizumab Pegol 200 mg | Experimental | Subjects will receive 200 mg of CZP given by subcutaneous injections in healthy Chinese subjects. The dose group begins treatment staggered by a minimum of 14 days from CZP 100 mg. Dose escalation will be suspended according to the predefined criteria and process. Receives: Biological: Certolizumab Pegol; Other: Placebo |
| Certolizumab Pegol 400 mg | Experimental | Subjects will receive 400 mg of CZP (two injections of CZP 200 mg) given by subcutaneous injections in healthy Chinese subjects. The dose group begins treatment staggered by a minimum of 14 days from CZP 200 mg. Dose escalation will be suspended according to the predefined criteria and process. Receives: Biological: Certolizumab Pegol; Other: Placebo |
| Placebo | Placebo comparator | For assessment of the Adverse Event (AE) profile, there are 2 placebo controls in each dose group. The placebo subjects receive the injection of saline (NaCl 0.9 %) at the same time (and of the same volume) as the CZP subjects. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The area under the plasma concentration-time curve from time zero up to the last analytically quantifiable concentration (AUC 0-t)
AUC 0-t is within a period of 70 days following the dose of CZP, reported in units of μg/mL·h, as determined using the linear trapezoidal rule.
Measured: D1 (pre-dose and 1, 2, 4, 8, 12 hrs post-dose), D2 (24, 36 hrs post-dose), D3 (48 hrs post-dose), D4 (72 hrs post-dose), D5 (96 hrs post-dose), D6, D8, D15, D22, D29, D43, D57 and D70
Maximum plasma concentration (Cmax)
The maximum observed plasma concentration of CZP.
Measured: D1 (pre-dose and 1, 2, 4, 8, 12 hrs post-dose), D2 (24, 36 hrs post-dose), D3 (48 hrs post-dose), D4 (72 hrs post-dose), D5 (96 hrs post-dose), D6, D8, D15, D22, D29, D43, D57 and D70
Secondary outcomes (3)
Area under the plasma concentration-time curve from zero up to infinity (AUC)
AUC is calculated as AUC=AUC(0-t)+Clast/λz, where Clast is the last quantifiable plasma concentration and λz is the apparent terminal elimination rate constant.
Measured: D1 (pre-dose and 1, 2, 4, 8, 12 hrs post-dose), D2 (24, 36 hrs post-dose), D3 (48 hrs post-dose), D4 (72 hrs post-dose), D5 (96 hrs post-dose), D6, D8, D15, D22, D29, D43, D57 and D70
Time to reach a maximum plasma concentration (Tmax)
The time of occurrence of Cmax.
Measured: D1 (pre-dose and 1, 2, 4, 8, 12 hrs post-dose), D2 (24, 36 hrs post-dose), D3 (48 hrs post-dose), D4 (72 hrs post-dose), D5 (96 hrs post-dose), D6, D8, D15, D22, D29, D43, D57 and D70
Terminal half-life (t½)
t½ is reported in units of hours, as determined via simple linear regression (slope=-λz) of natural log(ln) concentration vs time for data points in the terminal phase of the concentration-tim curve. t½ is calculated as ln(2)/λz.
Measured: D1 (pre-dose and 1, 2, 4, 8, 12 hrs post-dose), D2 (24, 36 hrs post-dose), D3 (48 hrs post-dose), D4 (72 hrs post-dose), D5 (96 hrs post-dose), D6, D8, D15, D22, D29, D43, D57 and D70
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02365948
- Sponsor's protocol ID
- RA0045
- Status last verified
- Aug 2015
- First submitted
- 11 Feb 2015
- Last updated
- 14 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Single Escalating Dose Study of Subcutaneous Certolizumab Pegol (CZP) to Evaluate the Pharmacokinetics and Safety of CZP in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT02365948
- Acronym / sponsor ID
- RA0045
- Conditions
- Healthy Subjects
- Keywords
- Pharmacokinetics, Certolizumab Pegol, Healthy Chinese subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- UCB Pharma SAIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- Mar 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 19 Feb 2015 (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 study will characterize the pharmacokinetics (PK) of certolizumab pegol (CZP) and evaluate safety of CZP in healthy Chinese subjects. 36 subjects will be randomized to receive one of 3 dose levels of CZP or placebo. The total study duration will be approximately 71-94 days for each subject.
Detailed description
This is a Phase 1, randomized, double-blind, placebo-controlled, single-center, single escalating dose study in healthy Chinese subjects. The primary objective of the study is to characterize the pharmacokinetics (PK) of certolizumab pegol (CZP) in healthy Chinese subjects after a single subcutaneous (sc) dose. The secondary objective is to evaluate safety of CZP in healthy Chinese subjects after a single sc dose. 36 healthy Chinese subjects (18 male and 18 female) will be randomized to receive one of 3 dose levels of CZP (100 mg, 200 mg and 400 mg) or placebo given by sc injections. Each dose group begins treatment staggered by a minimum of 14 days. The total duration of the study will be approximately 71 to 94 days for each subject. This includes a 2 to 21 days Screening Period, 1 day of treatment and 70 days Observation Period after administration of a single dose of investigational medicinal product.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Certolizumab Pegol 100 mg | Experimental | Biological: Certolizumab Pegol, Other: PlaceboSubjects will receive100 mg of CZP given by subcutaneous injections in healthy Chinese subjects. The dose group begins treatment on Day 1. To achieve an injectable CZP 100 mg dose, a manual process will be applied by the unblinded site pharmacist. |
| Certolizumab Pegol 200 mg | Experimental | Biological: Certolizumab Pegol, Other: PlaceboSubjects will receive 200 mg of CZP given by subcutaneous injections in healthy Chinese subjects. The dose group begins treatment staggered by a minimum of 14 days from CZP 100 mg. Dose escalation will be suspended according to the predefined criteria and process. |
| Certolizumab Pegol 400 mg | Experimental | Biological: Certolizumab Pegol, Other: PlaceboSubjects will receive 400 mg of CZP (two injections of CZP 200 mg) given by subcutaneous injections in healthy Chinese subjects. The dose group begins treatment staggered by a minimum of 14 days from CZP 200 mg. Dose escalation will be suspended according to the predefined criteria and process. |
| Placebo | Placebo comparator | Other: PlaceboFor assessment of the Adverse Event (AE) profile, there are 2 placebo controls in each dose group. The placebo subjects receive the injection of saline (NaCl 0.9 %) at the same time (and of the same volume) as the CZP subjects. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- An Institutional Review Board (IRB) / Independent Ethics Committee (IEC) approved written Informed Consent Form (ICF) is signed and dated by the subject
- Subject is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule or medication intake according to the judgment of the investigator
- Subject is male or female between 18 and 45 years of age, inclusive
- Results of clinical laboratory tests within the reference range of the laboratory or outside the reference range of the laboratory but considered as nonclinically significant by the investigator. This is not allowed for aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) and bilirubin values above the upper limit of normal (ULN) ranges
- Have a body weight of 50 to 80 kg and a body mass index (BMI) between 19 and 24 kg/m^2
Key exclusion criteria (20 listed)
- Active malignancies or a history of malignancy, excluding basal cell carcinoma of the skin that had been excised prior to study start
- History of adverse reaction to polyethylene glycol
- History of severe or multiple allergies
- Known Tuberculosis (TB) disease, high risk of acquiring TB infection, or latent TB infection
- A history of chronic infection, recent serious or life-threatening infection (within 6 months, including herpes zoster), or a current sign or symptom that may indicated an infection
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 |
|---|---|---|
| Certolizumab PegolAlso: Cimzia, CDP870, CZP* Active Substance: Certolizumab Pegol * Pharmaceutical Form: Prefilled syringes * Concentration: 200 mg/mL * Route of Administration: Subcutaneous injection | Biological | Certolizumab Pegol 100 mg, Certolizumab Pegol 200 mg, Certolizumab Pegol 400 mg |
| PlaceboAlso: PBO* Active Substance: Placebo * Pharmaceutical Form: Prefilled syringes * Concentration: 0.9 % Saline * Route of Administration: Subcutaneous injection | Other | Certolizumab Pegol 100 mg, Certolizumab Pegol 200 mg, Certolizumab Pegol 400 mg, Placebo |
Primary outcome
The area under the plasma concentration-time curve from time zero up to the last analytically quantifiable concentration (AUC 0-t)
Time frame: D1 (pre-dose and 1, 2, 4, 8, 12 hrs post-dose), D2 (24, 36 hrs post-dose), D3 (48 hrs post-dose), D4 (72 hrs post-dose), D5 (96 hrs post-dose), D6, D8, D15, D22, D29, D43, D57 and D70
AUC 0-t is within a period of 70 days following the dose of CZP, reported in units of μg/mL·h, as determined using the linear trapezoidal rule.
Maximum plasma concentration (Cmax)
Time frame: D1 (pre-dose and 1, 2, 4, 8, 12 hrs post-dose), D2 (24, 36 hrs post-dose), D3 (48 hrs post-dose), D4 (72 hrs post-dose), D5 (96 hrs post-dose), D6, D8, D15, D22, D29, D43, D57 and D70
The maximum observed plasma concentration of CZP.
3 secondary outcomes
Area under the plasma concentration-time curve from zero up to infinity (AUC)
Time frame: D1 (pre-dose and 1, 2, 4, 8, 12 hrs post-dose), D2 (24, 36 hrs post-dose), D3 (48 hrs post-dose), D4 (72 hrs post-dose), D5 (96 hrs post-dose), D6, D8, D15, D22, D29, D43, D57 and D70
Time to reach a maximum plasma concentration (Tmax)
Time frame: D1 (pre-dose and 1, 2, 4, 8, 12 hrs post-dose), D2 (24, 36 hrs post-dose), D3 (48 hrs post-dose), D4 (72 hrs post-dose), D5 (96 hrs post-dose), D6, D8, D15, D22, D29, D43, D57 and D70
Terminal half-life (t½)
Time frame: D1 (pre-dose and 1, 2, 4, 8, 12 hrs post-dose), D2 (24, 36 hrs post-dose), D3 (48 hrs post-dose), D4 (72 hrs post-dose), D5 (96 hrs post-dose), D6, D8, D15, D22, D29, D43, D57 and D70
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 14 Aug 2015.
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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 Clinical Trial Call Center study director
+1 877 822 9493 (UCB)
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 Certolizumab Pegol in people with Healthy Subjects, run by UCB Pharma SA at 1 site in China.
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 10 inclusion and 20 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 14 Aug 2015. 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 China. 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. Some participants in this study may receive a placebo. 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?
The area under the plasma concentration-time curve from time zero up to the last analytically quantifiable concentration (AUC 0-t) (time frame: D1 (pre-dose and 1, 2, 4, 8, 12 hrs post-dose), D2 (24, 36 hrs post-dose), D3 (48 hrs post-dose), D4 (72 hrs post-dose), D5 (96 hrs post-dose), D6, D8, D15, D22, D29, D43, D57 and D70). 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 14 Aug 2015.