PharmacokineticsPhase 1NCT01276119
The First Clinical Study to Test Safety, Blood Levels and Other Effects of CDP6038 in Healthy Males
A Phase 1 study testing CDP6038 in people with Pharmacokinetics, run by UCB Pharma at 1 site in Germany.
Trial summary
To evaluate the safety, tolerability, blood levels and effects of CDP6038 administered by intravenous infusion (iv) and subcutaneous (sc) injection. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- 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
- 67 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2008to Oct 2009
- 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index between 19.0 and 28.0 kg/m² and body weight between ≥ 50 kg and ≤ 120 kg
Who cannot join
- Previous trial participation or blood donation/loss within 3 months
- Subject is not healthy (eg significant medical history, taking drug treatments, any psychological or emotional problems, or drug or alcohol abuse (current or historical)
- Plans for or actual vaccination within 3 months
- Previous drug treatments
- Tobacco use or heavy caffeine consumption
- Systolic blood pressure <90 or >145mmHg, diastolic blood pressure <40 or >90mmHg or heart rate <45 or >90 beats per minute
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, Dose-escalating Study to Evaluate the Safety and Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of CDP6038 in Healthy Male Subjects
To evaluate the safety, tolerability, blood levels and effects of CDP6038 administered by intravenous infusion (iv) and subcutaneous (sc) injection.
- Conditions
- Pharmacokinetics
- Being tested
- CDP6038, Placebo
- Keywords
- CDP6038, single-dose, pharmacokinetics, healthy subjects
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 infusion over 60 minutes
CDP6038Biological
100 mg/mL solution for injection Single infusion over 120 minutes
CDP6038Biological
100 mg/mL solution for injection Single sc injection
PlaceboOther
0.9% sodium chloride for injection Single infusion over 60 minutes
PlaceboOther
0.9% sodium chloride for injection Single infusion over 120 minutes
PlaceboOther
0.9% sodium chloride for injection Single sc injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort A, CDP6038 0.001 mg/kg, iv | Experimental | Not described Receives: Biological: CDP6038 |
| Cohort B, CDP6038 0.01 mg/kg, iv | Experimental | Not described Receives: Biological: CDP6038 |
| Cohort C, CDP6038 0.03 mg/kg, iv | Experimental | Not described Receives: Biological: CDP6038 |
| Cohort D, CDP6038 0.1 mg/kg, iv | Experimental | Not described Receives: Biological: CDP6038 |
| Cohort E, CDP6038 0.3 mg/kg, iv | Experimental | Not described Receives: Biological: CDP6038 |
| Cohort G, CDP6038 1.0 mg/kg, iv | Experimental | Not described Receives: Biological: CDP6038 |
| Cohort I, CDP6038 3.0 mg/kg, iv | Experimental | Not described Receives: Biological: CDP6038 |
| Cohort K, CDP6038 10.0 mg/kg, iv | Experimental | Not described Receives: Biological: CDP6038 |
| Cohort A, Placebo, iv | Placebo comparator | Not described Receives: Other: Placebo |
| Cohort B, C, D, E, G, I, K, Placebo, iv | Placebo comparator | Not described Receives: Other: Placebo |
| Cohort F, CDP6038 0.3 mg/kg, sc | Experimental | Not described Receives: Biological: CDP6038 |
| Cohort H, CDP6038 1.0 mg/kg, sc | Experimental | Not described Receives: Biological: CDP6038 |
| Cohort J, CDP6038 3.0 mg/kg, sc | Experimental | Not described Receives: Biological: CDP6038 |
| Cohort F, H, J, Placebo, sc | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum drug concentration (Cmax) of CDP6038 in plasma given by intravenous (iv) infusion and subcutaneous (sc) injection in healthy male subjects.
Measured: Baseline to 14 weeks
The area under the plasma concentration/time curve from hour 0 to the time with the last quantifiable level of CDP6038 given by iv infusion and sc injection in healthy male subjects.
Measured: Baseline to 14 weeks
The area under the plasma concentration/time curve extrapolated to infinity, of CDP6038 given by iv infusion and sc injection in healthy male subjects.
Measured: Baseline to 14 weeks
The half life of CDP6038 in plasma given by iv infusion and sc injection in healthy male subjects.
Measured: Baseline to 14 weeks
The apparent volume of distribution of CDP6038 given by iv infusion and sc injection in healthy male subjects.
Measured: Baseline to 14 weeks
Total body clearance of CDP6038 in plasma given by iv infusion and sc injection in healthy male subjects.
Measured: Baseline to 14 weeks
PK/PD relationship between systemic CDP6038 exposure and suppression of selected acute phase markers (such as C-reactive protein) following CDP6038 administration by iv infusion and sc injection in healthy male subjects.
Measured: Baseline to 14 weeks
Secondary outcomes (1)
Anti-CDP6038 antibodies in plasma following iv infusion and sc injection of CDP6038 in healthy male subjects.
Measured: Baseline to 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2011 (estimated)
- Study startSep 2008
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 67 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
- NCT01276119
- Sponsor's protocol ID
- RA0001
- Status last verified
- Mar 2012
- First submitted
- 11 Jan 2011
- Last updated
- 22 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2012. 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, Dose-escalating Study to Evaluate the Safety and Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of CDP6038 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01276119
- Acronym / sponsor ID
- RA0001
- Conditions
- Pharmacokinetics
- Keywords
- CDP6038, single-dose, pharmacokinetics, healthy subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 13 Jan 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.
To evaluate the safety, tolerability, blood levels and effects of CDP6038 administered by intravenous infusion (iv) and subcutaneous (sc) injection.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| Cohort A, CDP6038 0.001 mg/kg, iv | Experimental | Biological: CDP6038 |
| Cohort B, CDP6038 0.01 mg/kg, iv | Experimental | Biological: CDP6038 |
| Cohort C, CDP6038 0.03 mg/kg, iv | Experimental | Biological: CDP6038 |
| Cohort D, CDP6038 0.1 mg/kg, iv | Experimental | Biological: CDP6038 |
| Cohort E, CDP6038 0.3 mg/kg, iv | Experimental | Biological: CDP6038 |
| Cohort G, CDP6038 1.0 mg/kg, iv | Experimental | Biological: CDP6038 |
| Cohort I, CDP6038 3.0 mg/kg, iv | Experimental | Biological: CDP6038 |
| Cohort K, CDP6038 10.0 mg/kg, iv | Experimental | Biological: CDP6038 |
| Cohort A, Placebo, iv | Placebo comparator | Other: Placebo |
| Cohort B, C, D, E, G, I, K, Placebo, iv | Placebo comparator | Other: Placebo |
| Cohort F, CDP6038 0.3 mg/kg, sc | Experimental | Biological: CDP6038 |
| Cohort H, CDP6038 1.0 mg/kg, sc | Experimental | Biological: CDP6038 |
| Cohort J, CDP6038 3.0 mg/kg, sc | Experimental | Biological: CDP6038 |
| Cohort F, H, J, Placebo, sc | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body mass index between 19.0 and 28.0 kg/m² and body weight between ≥ 50 kg and ≤ 120 kg
Key exclusion criteria (6 listed)
- Previous trial participation or blood donation/loss within 3 months
- Subject is not healthy (eg significant medical history, taking drug treatments, any psychological or emotional problems, or drug or alcohol abuse (current or historical)
- Plans for or actual vaccination within 3 months
- Previous drug treatments
- Tobacco use or heavy caffeine consumption
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 infusion over 60 minutes | Biological | Cohort A, CDP6038 0.001 mg/kg, iv |
| CDP6038100 mg/mL solution for injection Single infusion over 120 minutes | Biological | Cohort B, CDP6038 0.01 mg/kg, iv, Cohort C, CDP6038 0.03 mg/kg, iv, Cohort D, CDP6038 0.1 mg/kg, iv, Cohort E, CDP6038 0.3 mg/kg, iv, Cohort G, CDP6038 1.0 mg/kg, iv, Cohort I, CDP6038 3.0 mg/kg, iv, Cohort K, CDP6038 10.0 mg/kg, iv |
| CDP6038100 mg/mL solution for injection Single sc injection | Biological | Cohort F, CDP6038 0.3 mg/kg, sc, Cohort H, CDP6038 1.0 mg/kg, sc, Cohort J, CDP6038 3.0 mg/kg, sc |
| Placebo0.9% sodium chloride for injection Single infusion over 60 minutes | Other | Cohort A, Placebo, iv |
| Placebo0.9% sodium chloride for injection Single infusion over 120 minutes | Other | Cohort B, C, D, E, G, I, K, Placebo, iv |
| Placebo0.9% sodium chloride for injection Single sc injection | Other | Cohort F, H, J, Placebo, sc |
Primary outcome
The maximum drug concentration (Cmax) of CDP6038 in plasma given by intravenous (iv) infusion and subcutaneous (sc) injection in healthy male subjects.
Time frame: Baseline to 14 weeks
The area under the plasma concentration/time curve from hour 0 to the time with the last quantifiable level of CDP6038 given by iv infusion and sc injection in healthy male subjects.
Time frame: Baseline to 14 weeks
The area under the plasma concentration/time curve extrapolated to infinity, of CDP6038 given by iv infusion and sc injection in healthy male subjects.
Time frame: Baseline to 14 weeks
The half life of CDP6038 in plasma given by iv infusion and sc injection in healthy male subjects.
Time frame: Baseline to 14 weeks
The apparent volume of distribution of CDP6038 given by iv infusion and sc injection in healthy male subjects.
Time frame: Baseline to 14 weeks
Total body clearance of CDP6038 in plasma given by iv infusion and sc injection in healthy male subjects.
Time frame: Baseline to 14 weeks
PK/PD relationship between systemic CDP6038 exposure and suppression of selected acute phase markers (such as C-reactive protein) following CDP6038 administration by iv infusion and sc injection in healthy male subjects.
Time frame: Baseline to 14 weeks
1 secondary outcome
Anti-CDP6038 antibodies in plasma following iv infusion and sc injection of CDP6038 in healthy male subjects.
Time frame: Baseline to 14 weeks
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 22 Mar 2012.
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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 CDP6038 in people with Pharmacokinetics, run by UCB Pharma at 1 site in Germany.
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 6 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 22 Mar 2012. 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 Germany. 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 maximum drug concentration (Cmax) of CDP6038 in plasma given by intravenous (iv) infusion and subcutaneous (sc) injection in healthy male subjects. (time frame: Baseline to 14 weeks). The study lists 7 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 22 Mar 2012.