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The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of single escalating doses PF-06342674.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. Placebo | Placebo Comparator | Placebo |
|
| 2.0 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo |
| |
| PF-06342674 Dose A |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose limiting or intolerable treatment related AEs | 60 days | |
| Incidence of treatment emergent AEs | 60 days | |
| Incidence of abnormal laboratory findings | 60 days | |
| Changes from baseline in safety laboratory assessments | 60 days | |
| Abnormal and clinically relevant changes in vital signs, blood pressure, and ECG parameters | 60 days | |
| Incidence of anti-drug-antibodies | 60 days | |
| Severity of treatment emergent AEs | 60 days | |
| Causal relationship of treatment emergent AEs | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the Concentration-Time Curve (AUC) | AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. | 60 days |
| Maximum Observed Plasma Concentration (Cmax) |
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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 Investigational Site | New Haven | Connecticut | 06511 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Biological |
Single SC Dose |
|
| PF-06342674 Dose B | Biological | Single SC Dose |
|
| PF-06342674 Dose C | Biological | Single SC Dose |
|
| PF-06342674 Dose D | Biological | Single SC Dose |
|
| PF-06342674 Dose E | Biological | Single SC Dose |
|
| PF-06342674 Dose F | Biological | Single IV Dose |
|
| PF-06342674 Dose G | Biological | Single SC Dose |
|
| PF-06342674 Dose H | Biological | Single IV Dose |
|
| PF-06342674 Dose I | Biological | Single SC Dose |
|
| PF-06342674 Dose J | Biological | Single IV Dose |
|
| 60 days |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | 60 days |
| PK parameter estimates including T1/2. | 60 days |
| Systemic Clearance (CL) | CL is a quantitative measure of the rate at which a drug substance is removed from the body. | 60 days |
| Apparent Oral Clearance (CL/F) | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was 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. | 60 days |
| Apparent Volume of Distribution (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 oral dose (Vz/F) is influenced by the fraction absorbed. | 60 days |