The First Clinical Study to Test Safety, Blood Levels and Other Effects of CDP6038 in Healthy Males

Study Overview
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Brief Summary
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To evaluate the safety, tolerability, blood levels and effects of CDP6038 administered by intravenous infusion (iv) and subcutaneous (sc) injection.

Official Title
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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

Conditions
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Pharmacokinetics

Intervention / Treatment
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* Biological: CDP6038
* Biological: CDP6038
* Biological: CDP6038
* Other: Placebo
* Other: Placebo
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index between 19.0 and 28.0 kg/m² and body weight between ≥ 50 kg and ≤ 120 kg Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort A, CDP6038 0.001 mg/kg, iv<br> | Biological: CDP6038<br>* 100 mg/mL solution for injection Single infusion over 60 minutes<br>|
| Experimental: Cohort B, CDP6038 0.01 mg/kg, iv<br> | Biological: CDP6038<br>* 100 mg/mL solution for injection Single infusion over 120 minutes<br>|
| Experimental: Cohort C, CDP6038 0.03 mg/kg, iv<br> | Biological: CDP6038<br>* 100 mg/mL solution for injection Single infusion over 120 minutes<br>|
| Experimental: Cohort D, CDP6038 0.1 mg/kg, iv<br> | Biological: CDP6038<br>* 100 mg/mL solution for injection Single infusion over 120 minutes<br>|
| Experimental: Cohort E, CDP6038 0.3 mg/kg, iv<br> | Biological: CDP6038<br>* 100 mg/mL solution for injection Single infusion over 120 minutes<br>|
| Experimental: Cohort G, CDP6038 1.0 mg/kg, iv<br> | Biological: CDP6038<br>* 100 mg/mL solution for injection Single infusion over 120 minutes<br>|
| Experimental: Cohort I, CDP6038 3.0 mg/kg, iv<br> | Biological: CDP6038<br>* 100 mg/mL solution for injection Single infusion over 120 minutes<br>|
| Experimental: Cohort K, CDP6038 10.0 mg/kg, iv<br> | Biological: CDP6038<br>* 100 mg/mL solution for injection Single infusion over 120 minutes<br>|
| Placebo Comparator: Cohort A, Placebo, iv<br> | Other: Placebo<br>* 0.9% sodium chloride for injection Single infusion over 60 minutes<br>|
| Placebo Comparator: Cohort B, C, D, E, G, I, K, Placebo, iv<br> | Other: Placebo<br>* 0.9% sodium chloride for injection Single infusion over 120 minutes<br>|
| Experimental: Cohort F, CDP6038 0.3 mg/kg, sc<br> | Biological: CDP6038<br>* 100 mg/mL solution for injection Single sc injection<br>|
| Experimental: Cohort H, CDP6038 1.0 mg/kg, sc<br> | Biological: CDP6038<br>* 100 mg/mL solution for injection Single sc injection<br>|
| Experimental: Cohort J, CDP6038 3.0 mg/kg, sc<br> | Biological: CDP6038<br>* 100 mg/mL solution for injection Single sc injection<br>|
| Placebo Comparator: Cohort F, H, J, Placebo, sc<br> | Other: Placebo<br>* 0.9% sodium chloride for injection Single sc injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The maximum drug concentration (Cmax) of CDP6038 in plasma given by intravenous (iv) infusion and subcutaneous (sc) injection in healthy male subjects. |  | 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. |  | 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. |  | Baseline to 14 weeks | 
| The half life of CDP6038 in plasma given by iv infusion and sc injection in healthy male subjects. |  | Baseline to 14 weeks | 
| The apparent volume of distribution of CDP6038 given by iv infusion and sc injection in healthy male subjects. |  | Baseline to 14 weeks | 
| Total body clearance of CDP6038 in plasma given by iv infusion and sc injection in healthy male subjects. |  | 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. |  | Baseline to 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-CDP6038 antibodies in plasma following iv infusion and sc injection of CDP6038 in healthy male subjects. |  | Baseline to 14 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CDP6038, single-dose, pharmacokinetics, healthy subjects