Healthy VolunteersPhase 1NCT01262794
Pharmacokinetic (PK)/Pharmacodynamic (PD), Study of Single-dose Subcutaneous CDP6038 in Healthy Japanese Male Subjects
A Phase 1 study testing CDP6038 in people with Healthy Volunteers, run by UCB Pharma at 1 site in United Kingdom.
Trial summary
To evaluate the safety and tolerability of CDP6038 following single dose subcutaneous (sc) administration of CDP6038 to Japanese subjects. To evaluate the Pharmacokinetics of CDP6038 following single dose sc administration of CDP6038 to Japanese subjects Read more about this study
- Who is it for?
- Ages 20 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- CDP6038
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2010to Sep 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 20 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Japanese volunteers
Who cannot join
- Subject has participated in any other clinical drug study (including a biologic product or a medical device) within 5 PK half-lives or 3 months (whichever is longer) prior to Screening, or the subject is currently participating in another clinical study.
- Subject is not healthy (eg, taking any drug treatments, any psychological or emotional problems, a drug/alcohol abuse or a having a history of drug/alcohol abuse, having abnormal safety parameters)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo Controlled, Single-center, Single Dose Study to Evaluate the Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of CDP6038 Administered Subcutaneously to Healthy Japanese Males
To evaluate the safety and tolerability of CDP6038 following single dose subcutaneous (sc) administration of CDP6038 to Japanese subjects.
To evaluate the Pharmacokinetics of CDP6038 following single dose sc administration of CDP6038 to Japanese subjects
- Conditions
- Healthy Volunteers
- Being tested
- CDP6038, Placebo
- Keywords
- Healthy volunteers, Japanese
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDP6038Biological
100 mg/mL solution for injection, single dose
PlaceboBiological
0.9% sodium chloride for injection Single-dose
| Study group | Role | What they receive |
|---|---|---|
| CDP6038 0.3 mg/kg | Experimental | Not described Receives: Biological: CDP6038 |
| CDP6038 1 mg/kg | Experimental | Not described Receives: Biological: CDP6038 |
| CDP6038 3 mg/kg | Experimental | Not described Receives: Biological: CDP6038 |
| CDP6038 6 mg/kg | Experimental | Not described Receives: Biological: CDP6038 |
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum drug concentration (Cmax)
Measured: Multiple sampling from 0 to 113 days following single dose
Area under the plasma drug concentration versus time curve from hour 0 to the time with a last quantifiable level (AUC0-t)
Measured: Multiple sampling from 0 to 113 days following single dose
Area under the plasma drug concentration versus time curve extrapolated to infinity (AUC)
Measured: Multiple sampling from 0 to 113 days following single dose
Apparent volume of distribution (Vz/F)
Measured: Multiple sampling from 0 to 113 days following single dose
Apparent total body clearance (CL/F)
Measured: Multiple sampling from 0 to 113 days following single dose
Terminal elimination half-life (T½)
Measured: Multiple sampling from 0 to 113 days following single dose
Secondary outcomes (2)
PK/PD relationship between systemic CDP6038 exposure and suppression of selected acute phase markers (such as C-reactive protein), following single subcutaneous doses of CDP6038 in Japanese subjects
Measured: Multiple sampling from 0 to 15 weeks following single dose
Immunogenicity of single subcutaneous doses of CDP6038 in Japanese subjects
Measured: Multiple sampling from 0 to 15 weeks following single dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01262794
- Sponsor's protocol ID
- RA0074
- Other IDs
- 2010-022543-38
- Status last verified
- Sep 2011
- First submitted
- 16 Dec 2010
- Last updated
- 27 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo Controlled, Single-center, Single Dose Study to Evaluate the Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of CDP6038 Administered Subcutaneously to Healthy Japanese Males
- ClinicalTrials.gov ID
- NCT01262794
- Acronym / sponsor ID
- RA0074
- Conditions
- Healthy Volunteers
- Keywords
- Healthy volunteers, Japanese
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 17 Dec 2010 (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.
To evaluate the safety and tolerability of CDP6038 following single dose subcutaneous (sc) administration of CDP6038 to Japanese subjects.
To evaluate the Pharmacokinetics of CDP6038 following single dose sc administration of CDP6038 to Japanese subjects
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| CDP6038 0.3 mg/kg | Experimental | Biological: CDP6038 |
| CDP6038 1 mg/kg | Experimental | Biological: CDP6038 |
| CDP6038 3 mg/kg | Experimental | Biological: CDP6038 |
| CDP6038 6 mg/kg | Experimental | Biological: CDP6038 |
| Placebo | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy Japanese volunteers
Key exclusion criteria (2 listed)
- Subject has participated in any other clinical drug study (including a biologic product or a medical device) within 5 PK half-lives or 3 months (whichever is longer) prior to Screening, or the subject is currently participating in another clinical study.
- Subject is not healthy (eg, taking any drug treatments, any psychological or emotional problems, a drug/alcohol abuse or a having a history of drug/alcohol abuse, having abnormal safety parameters)
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 |
|---|---|---|
| CDP6038100 mg/mL solution for injection, single dose | Biological | CDP6038 0.3 mg/kg, CDP6038 1 mg/kg, CDP6038 3 mg/kg, CDP6038 6 mg/kg |
| Placebo0.9% sodium chloride for injection Single-dose | Biological | Placebo |
Primary outcome
Maximum drug concentration (Cmax)
Time frame: Multiple sampling from 0 to 113 days following single dose
Area under the plasma drug concentration versus time curve from hour 0 to the time with a last quantifiable level (AUC0-t)
Time frame: Multiple sampling from 0 to 113 days following single dose
Area under the plasma drug concentration versus time curve extrapolated to infinity (AUC)
Time frame: Multiple sampling from 0 to 113 days following single dose
Apparent volume of distribution (Vz/F)
Time frame: Multiple sampling from 0 to 113 days following single dose
Apparent total body clearance (CL/F)
Time frame: Multiple sampling from 0 to 113 days following single dose
Terminal elimination half-life (T½)
Time frame: Multiple sampling from 0 to 113 days following single dose
2 secondary outcomes
PK/PD relationship between systemic CDP6038 exposure and suppression of selected acute phase markers (such as C-reactive protein), following single subcutaneous doses of CDP6038 in Japanese subjects
Time frame: Multiple sampling from 0 to 15 weeks following single dose
Immunogenicity of single subcutaneous doses of CDP6038 in Japanese subjects
Time frame: Multiple sampling from 0 to 15 weeks following single dose
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 27 Sep 2011.
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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.
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 CDP6038 in people with Healthy Volunteers, run by UCB Pharma at 1 site in United Kingdom.
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 1 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 27 Sep 2011. 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 Kingdom. 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?
Maximum drug concentration (Cmax) (time frame: Multiple sampling from 0 to 113 days following single dose). The study lists 6 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 27 Sep 2011.