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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003568-36 | EudraCT Number |
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The study was terminated early on July 8, 2016 due to business priorities regarding study execution.
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| Name | Class |
|---|---|
| Halozyme Therapeutics | INDUSTRY |
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This is a Phase 1, open-label, single-dose, randomized, dose escalation study in healthy and hypercholesterolemic subjects. Each subject will receive 1 of 5 treatments as a single subcutaneous injection. Subjects will remain confined at the research clinic for approximately 2 days. After discharge, subjects will return to the research clinic 15 times during 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: bococizumab 150 mg + rHuPH20 | Experimental | bococizumab 150 mg co-mixed with rHuPH20 and administered subcutaneously to healthy volunteers |
|
| Cohort 2: bococizumab 300 mg | Active Comparator | bococizumab 300 mg administered subcutaneously to healthy volunteers |
|
| Cohort 3: bococizumab 300 mg + rHuPH20 | Experimental | bococizumab 300 mg co-mixed with rHuPH20 and administered subcutaneously to healthy volunteers |
|
| Cohort 5: bococizumab 450 mg + rHUPH20 | Experimental | bococizumab 450 mg co-mixed with rHuPH20 and administered subcutaneously to healthy volunteers |
|
| Cohort 4: bococizumab 300 mg + rHuPH20 | Experimental | bococizumab 300 mg co-mixed with rHuPH20 and administered subcutaneously to subjects with hypercholesterolemia receiving a statin |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cohort 1: bococizumab 150 mg + rHuPH20 | Biological | bococizumab 150 mg + rHuPH20 administered SC to healthy volunteers |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf of bococizumab | Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞), if data permits (otherwise AUClast will be used). | Day 1 - Day 85 |
| Cmax of bococizumab | Maximum Observed Plasma Concentration (Cmax) | Day 1 - Day 85 |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | Time to Reach Maximum Observed Plasma Concentration (Tmax) | Day 1 - Day 85 |
| CL/F | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent clearance is influenced by the fraction of the dose absorbed. Clearance is estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Clinical Research Unit | Brussels | B-1070 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30623096 | Derived | Bass A, Plotka A, Mridha K, Sattler C, Kim AM, Plowchalk DR. Pharmacokinetics, pharmacodynamics, and safety of bococizumab, a monoclonal antibody against proprotein convertase subtilisin/kexin type 9, in healthy subjects when administered in co-mixture with recombinant human hyaluronidase: A phase 1 randomized trial. Health Sci Rep. 2018 Jul 18;1(9):e61. doi: 10.1002/hsr2.61. eCollection 2018 Sep. |
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| Cohort 2: bococizumab 300 mg | Biological | bococizumab 300 mg administered SC to healthy volunteers |
|
| Cohort 3: bococizumab 300 mg + rHuPH20 | Biological | bococizumab 300 mg + rHuPH20 administered SC to healthy volunteers |
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| Cohort 5: bococizumab 450 mg + rHuPH20 | Biological | bococizumab 450 mg + rHuPH20 administered SC to healthy volunteers |
|
| Cohort 4: bococizumab 300 mg + rHuPH20 | Biological | bococizumab 300 mg + rHuPH20 administered SC to subjects with hypercholesterolemia receiving a statin |
|
| Day 1 - Day 85 |
| Vz/F | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after dose (Vz/F) is influenced by the fraction absorbed. | Day 1 - Day 85 |
| t1/2 | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | Day 1 - Day 85 |
| LDL-C at Week 4 | Absolute value, and absolute change and % change in LDL cholesterol at Week 4 following bococizumab administration alone and when co-mixed with rHuPH20. | Baseline to Week 4 |
| MaxELDL-C | Maximum LDL-C lowering calculated using absolute LDL-C values | Baseline up to Day 85 |
| Tmax, LDL-C | Time to MaxELDL-C calculated using absolute LDL-C values | Baseline up to Day 85 |
| AUEC85 | Area under the LDL-C concentration-time curve calculated using absolute LDL-C values | Baseline up to Day 85 |
| AEs | Incidence, severity, and causal relationship of treatment-emergent adverse events (TEAEs) | Baseline up to Day 85 |
| Laboratory tests | Incidence of abnormal and clinically relevant safety laboratory tests including clinical chemistry and hematology | Baseline up to Day 85 |
| Vital signs | Incidence of abnormal and clinically relevant vital signs | Baseline up to Day 85 |
| AUClast of bococizumab | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) | Day 1 - Day 85 |
| ADA | Incidence and titer of Anti-Drug Antibodies (ADA) following administration of bococizumab alone and when co-mixed with rHuPH20. | Day 1 - Day 85 |
| nAb | Incidence and titer of neutralizing antibodies (nAb), if applicable, following administration of bococizumab alone and when co-mixed with rHuPH20. | Day 1- Day 85 |
| To obtain contact information for a study center near you, click here. | View source |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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