| Primary | Maximum Observed Plasma Concentration (Cmax) of PF-04950615 | | Pharmacokinetic (PK) parameter analysis population included all participants randomized and treated who have at least 1 of the PK parameters of primary interest. | Posted | | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | | Pre-dose, 30 minutes, 1, 8, 24, 48, 72, 96, 120, 168, 336, 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 2016 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | PF-04950615 IV 200 mg | Participants received single intravenous (IV) infusion dose of PF-04950615 200 milligram (mg) on Day 1. Participants were followed up to Day 85. | | OG001 | PF-04950615 SC 200 mg (2 Injections of 1 mL) | Participants received subcutaneous (SC) dose of PF-04950615 200 mg on Day 1; 2 injections (100 milligram per milliliter [mg/mL]) of 1 milliliter (mL) each at two different quadrants of the abdomen; 1 injection per quadrant. Participants were followed up to Day 85. | | OG002 | PF-04950615 SC 200 mg (1 Injection of 2 mL) | Participants received single SC dose of PF-04950615 200 mg on Day 1; 1 injection (100 mg/mL) of 2 mL. Participants were followed up to Day 85. | | OG003 | PF-04950615 SC 100 mg (1 Injection of 1 mL) | Participants received single SC dose of PF-04950615 100 mg on Day 1; 1 injection (100 mg/mL) of 1 mL. Participants were followed up to Day 85. |
| | Units | Counts |
|---|
| Participants | - OG00012
- OG00113
- OG00213
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00065810± 14047
- OG00115900± 18289
- OG0028922± 4016.4
- OG003
|
|
| |
| Primary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04950615 | | PK parameter analysis population included all participants randomized and treated who have at least 1 of the PK parameters of primary interest. | Posted | | Median | Full Range | hour | | Pre-dose, 30 minutes, 1, 8, 24, 48, 72, 96, 120, 168, 336, 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 2016 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | PF-04950615 IV 200 mg | Participants received single intravenous (IV) infusion dose of PF-04950615 200 milligram (mg) on Day 1. Participants were followed up to Day 85. | | OG001 | PF-04950615 SC 200 mg (2 Injections of 1 mL) | Participants received subcutaneous (SC) dose of PF-04950615 200 mg on Day 1; 2 injections (100 milligram per milliliter [mg/mL]) of 1 milliliter (mL) each at two different quadrants of the abdomen; 1 injection per quadrant. Participants were followed up to Day 85. | | OG002 | PF-04950615 SC 200 mg (1 Injection of 2 mL) | Participants received single SC dose of PF-04950615 200 mg on Day 1; 1 injection (100 mg/mL) of 2 mL. Participants were followed up to Day 85. | | OG003 | PF-04950615 SC 100 mg (1 Injection of 1 mL) |
|
| Primary | Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of PF-04950615 | | PK parameter analysis population included all participants randomized and treated who have at least 1 of the PK parameters of primary interest. Here 'N' (Overall Number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | nanogram*hour per milliliter | | Pre-dose, 30 minutes, 1, 8, 24, 48, 72, 96, 120, 168, 336, 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 2016 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | PF-04950615 IV 200 mg | Participants received single intravenous (IV) infusion dose of PF-04950615 200 milligram (mg) on Day 1. Participants were followed up to Day 85. | | OG001 | PF-04950615 SC 200 mg (2 Injections of 1 mL) | Participants received subcutaneous (SC) dose of PF-04950615 200 mg on Day 1; 2 injections (100 milligram per milliliter [mg/mL]) of 1 milliliter (mL) each at two different quadrants of the abdomen; 1 injection per quadrant. Participants were followed up to Day 85. | | OG002 | PF-04950615 SC 200 mg (1 Injection of 2 mL) | Participants received single SC dose of PF-04950615 200 mg on Day 1; 1 injection (100 mg/mL) of 2 mL. Participants were followed up to Day 85. |
|
| Primary | Area Under the Plasma Concentration-Time Curve From Time Zero To Infinity (AUCinf) of PF-04950615 | | PK parameter analysis population included all participants randomized and treated who have at least 1 of the PK parameters of primary interest. Here 'N' signifies those participants who were evaluable for this measure. | Posted | | Mean | Standard Deviation | nanogram*hour per milliliter | | Pre-dose, 30 minutes, 1, 8, 24, 48, 72, 96, 120, 168, 336, 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 2016 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | PF-04950615 IV 200 mg | Participants received single intravenous (IV) infusion dose of PF-04950615 200 milligram (mg) on Day 1. Participants were followed up to Day 85. | | OG001 | PF-04950615 SC 200 mg (2 Injections of 1 mL) | Participants received subcutaneous (SC) dose of PF-04950615 200 mg on Day 1; 2 injections (100 milligram per milliliter [mg/mL]) of 1 milliliter (mL) each at two different quadrants of the abdomen; 1 injection per quadrant. Participants were followed up to Day 85. | | OG002 | PF-04950615 SC 200 mg (1 Injection of 2 mL) | Participants received single SC dose of PF-04950615 200 mg on Day 1; 1 injection (100 mg/mL) of 2 mL. Participants were followed up to Day 85. |
|
| Primary | Apparent Clearance (CL/F) of PF-04950615 Subcutaneous Groups | Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent clearance (CL/F) is influenced by the fraction of the dose absorbed from plasma after SC administration of drug. | PK parameter analysis population included all participants randomized and treated who have at least 1 of the PK parameters of primary interest. Here 'N' signifies those participants who were evaluable for this measure. This outcome measure was planned not to be analyzed in reporting arm: PF-04950615 IV 200 mg. | Posted | | Mean | Standard Deviation | milliliter per hour | | Pre-dose, 30 minutes, 1, 8, 24, 48, 72, 96, 120, 168, 336, 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 2016 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | PF-04950615 SC 200 mg (2 Injections of 1 mL) | Participants received subcutaneous (SC) dose of PF-04950615 200 mg on Day 1; 2 injections (100 milligram per milliliter [mg/mL]) of 1 milliliter (mL) each at two different quadrants of the abdomen; 1 injection per quadrant. Participants were followed up to Day 85. | | OG001 | PF-04950615 SC 200 mg (1 Injection of 2 mL) | Participants received single SC dose of PF-04950615 200 mg on Day 1; 1 injection (100 mg/mL) of 2 mL. Participants were followed up to Day 85. | | OG002 |
|
| Primary | Clearance (CL) of PF-04950615 Intravenous Group | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. | PK parameter analysis population. Here 'N' signifies those participants who were evaluable for this measure. This outcome measure was planned not to be analyzed in reporting arms: PF-04950615 SC 200 mg (2 injections of 1mL), PF-04950615 SC 200 mg (1 injection of 2 mL) and PF-04950615 SC 100 mg (1 injection of 1 mL). | Posted | | Mean | Standard Deviation | milliliter per hour | | Pre-dose, 30 minutes, 1, 8, 24, 48, 72, 96, 120, 168, 336, 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 2016 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | PF-04950615 IV 200 mg | Participants received single intravenous (IV) infusion dose of PF-04950615 200 milligram (mg) on Day 1. Participants were followed up to Day 85. |
| |
| Primary | Apparent Volume of Distribution (Vz/F) of PF-04950615 Subcutaneous Groups | Volume of distribution (Vz) 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. Vz/F is influenced by the fraction of the dose absorbed from plasma after SC administration of drug. | PK parameter analysis population included all participants randomized and treated who have at least 1 of the PK parameters of primary interest. Here 'N' signifies those participants who were evaluable for this measure. This outcome measure was planned not to be analyzed in reporting arm: PF-04950615 IV 200 mg. | Posted | | Mean | Standard Deviation | milliliter | | Pre-dose, 30 minutes, 1, 8, 24, 48, 72, 96, 120, 168, 336, 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 2016 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | PF-04950615 SC 200 mg (2 Injections of 1 mL) | Participants received subcutaneous (SC) dose of PF-04950615 200 mg on Day 1; 2 injections (100 milligram per milliliter [mg/mL]) of 1 milliliter (mL) each at two different quadrants of the abdomen; 1 injection per quadrant. Participants were followed up to Day 85. | | OG001 | PF-04950615 SC 200 mg (1 Injection of 2 mL) | Participants received single SC dose of PF-04950615 200 mg on Day 1; 1 injection (100 mg/mL) of 2 mL. Participants were followed up to Day 85. | |
|
| Primary | Volume of Distribution at Steady State (Vss) of PF-04950615 Intravenous Group | 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. Vss is determined when overall intake of drug is in dynamic equilibrium with its elimination. | PK parameter analysis population. Here 'N' signifies those participants who were evaluable for this measure. This outcome measure was planned not to be analyzed in reporting arms: PF-04950615 SC 200 mg (2 injections of 1mL), PF-04950615 SC 200 mg (1 injection of 2 mL) and PF-04950615 SC 100 mg (1 injection of 1 mL). | Posted | | Mean | Standard Deviation | milliliter | | Pre-dose, 30 minutes, 1, 8, 24, 48, 72, 96, 120, 168, 336, 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 2016 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | PF-04950615 IV 200 mg | Participants received single intravenous (IV) infusion dose of PF-04950615 200 milligram (mg) on Day 1. Participants were followed up to Day 85. |
| |
| Primary | Terminal Elimination Half-life (t1/2) of PF-04950615 | t1/2 is the time measured for the plasma concentration of drug to decrease by one half. | PK parameter analysis population included all participants randomized and treated who have at least 1 of the PK parameters of primary interest. Here 'N' signifies those participants who were evaluable for this measure. | Posted | | Mean | Standard Deviation | hour | | Pre-dose, 30 minutes, 1, 8, 24, 48, 72, 96, 120, 168, 336, 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 2016 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | PF-04950615 IV 200 mg | Participants received single intravenous (IV) infusion dose of PF-04950615 200 milligram (mg) on Day 1. Participants were followed up to Day 85. | | OG001 | PF-04950615 SC 200 mg (2 Injections of 1 mL) | Participants received subcutaneous (SC) dose of PF-04950615 200 mg on Day 1; 2 injections (100 milligram per milliliter [mg/mL]) of 1 milliliter (mL) each at two different quadrants of the abdomen; 1 injection per quadrant. Participants were followed up to Day 85. | | OG002 | PF-04950615 SC 200 mg (1 Injection of 2 mL) | Participants received single SC dose of PF-04950615 200 mg on Day 1; 1 injection (100 mg/mL) of 2 mL. Participants were followed up to Day 85. |
|
| Primary | Absolute Bioavailability of PF-04950615 Subcutaneous Groups | Bioavailability is defined as the rate and extent to which the active moiety administered drug reaches the systemic circulation. Absolute bioavailability of the subcutaneous doses was estimated by comparing log-transformed dose-normalized AUClast for subcutaneous to intravenous dose. | PK parameter analysis population included all participants randomized and treated who have at least 1 of the PK parameters of primary interest. Here 'N' signifies those participants who were evaluable for this measure. This outcome measure was not analyzed in reporting arm: PF-04950615 IV 200 mg. | Posted | | Number | 95% Confidence Interval | percentage of bioavailability | | Pre-dose, 30 minutes, 1, 8, 24, 48, 72, 96, 120, 168, 336, 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 2016 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | PF-04950615 SC 200 mg (2 Injections of 1 mL) | Participants received subcutaneous (SC) dose of PF-04950615 200 mg on Day 1; 2 injections (100 milligram per milliliter [mg/mL]) of 1 milliliter (mL) each at two different quadrants of the abdomen; 1 injection per quadrant. Participants were followed up to Day 85. | | OG001 | PF-04950615 SC 200 mg (1 Injection of 2 mL) | Participants received single SC dose of PF-04950615 200 mg on Day 1; 1 injection (100 mg/mL) of 2 mL. Participants were followed up to Day 85. | |
|
| Secondary | Absolute Value of Fasting Low-density Lipoprotein Cholesterol (LDL-C) | | Pharmacodynamic (PD) population included all participants randomized and treated who had at least 1 plasma concentration of PF-04950615, and lipid panel or proprotein convertase subtilisin/kexin type 9 (PCSK9) data. Here, "Number of participants analyzed" signifies number of participants evaluable at different time points. | Posted | | Mean | Standard Deviation | milligram per deciliter (mg/dL) | | Day 2, 3, 4, 5, 6, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 85 | | | | ID | Title | Description |
|---|
| OG000 | PF-04950615 IV 200 mg | Participants received single intravenous (IV) infusion dose of PF-04950615 200 milligram (mg) on Day 1. Participants were followed up to Day 85. | | OG001 | PF-04950615 SC 200 mg (2 Injections of 1 mL) | Participants received subcutaneous (SC) dose of PF-04950615 200 mg on Day 1; 2 injections (100 milligram per milliliter [mg/mL]) of 1 milliliter (mL) each at two different quadrants of the abdomen; 1 injection per quadrant. Participants were followed up to Day 85. | | OG002 | PF-04950615 SC 200 mg (1 Injection of 2 mL) | Participants received single SC dose of PF-04950615 200 mg on Day 1; 1 injection (100 mg/mL) of 2 mL. Participants were followed up to Day 85. |
|
| Secondary | Percent Change From Baseline in Fasting Low-density Lipoprotein Cholesterol (LDL-C) at Day 2, 3, 4, 5, 6, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71 and 85 | Baseline was the average of observations collected on Days 7 and 1 prior to the study treatment administration. | PD population included all participants randomized and treated who had at least 1 plasma concentration of PF-04950615, and lipid panel or PCSK9 data. Here, "Number of Participants Analyzed" signifies number of participants evaluable at different time points. | Posted | | Mean | Standard Deviation | percent change | | Baseline, Day 2, 3, 4, 5, 6, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 85 | | | | ID | Title | Description |
|---|
| OG000 | PF-04950615 IV 200 mg | Participants received single intravenous (IV) infusion dose of PF-04950615 200 milligram (mg) on Day 1. Participants were followed up to Day 85. | | OG001 | PF-04950615 SC 200 mg (2 Injections of 1 mL) | Participants received subcutaneous (SC) dose of PF-04950615 200 mg on Day 1; 2 injections (100 milligram per milliliter [mg/mL]) of 1 milliliter (mL) each at two different quadrants of the abdomen; 1 injection per quadrant. Participants were followed up to Day 85. | | OG002 | PF-04950615 SC 200 mg (1 Injection of 2 mL) | |
|
| Secondary | Duration of Fasting LDL-C Suppressed Below 70 mg/dL and 100 mg/dL | | PD population included all participants randomized and treated who had at least 1 plasma concentration of PF-04950615, and lipid panel or PCSK9 data. Here, "Number of Participants Analyzed" signifies number of participants evaluable at different time points. | Posted | | Mean | Standard Deviation | days | | Day 1 up to Day 85 | | | | ID | Title | Description |
|---|
| OG000 | PF-04950615 IV 200 mg | Participants received single intravenous (IV) infusion dose of PF-04950615 200 milligram (mg) on Day 1. Participants were followed up to Day 85. | | OG001 | PF-04950615 SC 200 mg (2 Injections of 1 mL) | Participants received subcutaneous (SC) dose of PF-04950615 200 mg on Day 1; 2 injections (100 milligram per milliliter [mg/mL]) of 1 milliliter (mL) each at two different quadrants of the abdomen; 1 injection per quadrant. Participants were followed up to Day 85. | | OG002 | PF-04950615 SC 200 mg (1 Injection of 2 mL) | Participants received single SC dose of PF-04950615 200 mg on Day 1; 1 injection (100 mg/mL) of 2 mL. Participants were followed up to Day 85. | | OG003 | PF-04950615 SC 100 mg (1 Injection of 1 mL) |
|
| Other Pre-specified | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. | Safety analysis set included all participants who had at least 1 dose of study medication. | Posted | | Count of Participants | | Participants | | Day 1 up to Day 85 | | | | ID | Title | Description |
|---|
| OG000 | PF-04950615 IV 200 mg | Participants received single intravenous (IV) infusion dose of PF-04950615 200 milligram (mg) on Day 1. Participants were followed up to Day 85. | | OG001 | PF-04950615 SC 200 mg (2 Injections of 1 mL) | Participants received subcutaneous (SC) dose of PF-04950615 200 mg on Day 1; 2 injections (100 milligram per milliliter [mg/mL]) of 1 milliliter (mL) each at two different quadrants of the abdomen; 1 injection per quadrant. Participants were followed up to Day 85. |
|
| Other Pre-specified | Number of Adverse Events (AEs) by Severity | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event) and severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to adverse event). | Safety analysis set included all participants who had at least 1 dose of study medication. | Posted | | Number | | adverse events | | Day 1 up to Day 85 | | | | ID | Title | Description |
|---|
| OG000 | PF-04950615 IV 200 mg | Participants received single intravenous (IV) infusion dose of PF-04950615 200 milligram (mg) on Day 1. Participants were followed up to Day 85. | | OG001 | PF-04950615 SC 200 mg (2 Injections of 1 mL) | Participants received subcutaneous (SC) dose of PF-04950615 200 mg on Day 1; 2 injections (100 milligram per milliliter [mg/mL]) of 1 milliliter (mL) each at two different quadrants of the abdomen; 1 injection per quadrant. Participants were followed up to Day 85. | | OG002 | PF-04950615 SC 200 mg (1 Injection of 2 mL) |
|
| Other Pre-specified | Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Safety analysis set included all participants who had at least 1 dose of study medication. | Posted | | Count of Participants | | Participants | | Day 1 up to Day 85 | | | | ID | Title | Description |
|---|
| OG000 | PF-04950615 IV 200 mg | Participants received single intravenous (IV) infusion dose of PF-04950615 200 milligram (mg) on Day 1. Participants were followed up to Day 85. | | OG001 | PF-04950615 SC 200 mg (2 Injections of 1 mL) | Participants received subcutaneous (SC) dose of PF-04950615 200 mg on Day 1; 2 injections (100 milligram per milliliter [mg/mL]) of 1 milliliter (mL) each at two different quadrants of the abdomen; 1 injection per quadrant. Participants were followed up to Day 85. | | OG002 | PF-04950615 SC 200 mg (1 Injection of 2 mL) | |
|
| Other Pre-specified | Number of Participants With Injection Site Reactions | The injection site reaction included erythema, induration, ecchymosis, injection site pain, injection site pruritus. | Safety analysis set included all participants who had at least 1 dose of study medication. This outcome measure was planned not to be analyzed in reporting arm: PF-04950615 200 mg. | Posted | | Count of Participants | | Participants | | Day 1 up to Day 3 | | | | ID | Title | Description |
|---|
| OG000 | PF-04950615 SC 200 mg (2 Injections of 1 mL) | Participants received subcutaneous (SC) dose of PF-04950615 200 mg on Day 1; 2 injections (100 milligram per milliliter [mg/mL]) of 1 milliliter (mL) each at two different quadrants of the abdomen; 1 injection per quadrant. Participants were followed up to Day 85. | | OG001 | PF-04950615 SC 200 mg (1 Injection of 2 mL) | Participants received single SC dose of PF-04950615 200 mg on Day 1; 1 injection (100 mg/mL) of 2 mL. Participants were followed up to Day 85. | | OG002 | PF-04950615 SC 100 mg (1 Injection of 1 mL) | Participants received single SC dose of PF-04950615 100 mg on Day 1; 1 injection (100 mg/mL) of 1 mL. Participants were followed up to Day 85. |
|
| Other Pre-specified | Number of Injection Site Reactions Reported as Adverse Events | The injection site reactions included erythema, induration, ecchymosis, injection site pain and injection site pruritus. An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. | Safety analysis set included all participants who had at least 1 dose of study medication. This outcome measure was planned not to be analyzed in reporting arm: PF-04950615 200 mg IV. | Posted | | Number | | injection site reactions | | Day 1 up to Day 3 | | | | ID | Title | Description |
|---|
| OG000 | PF-04950615 SC 200 mg (2 Injections of 1 mL) | Participants received subcutaneous (SC) dose of PF-04950615 200 mg on Day 1; 2 injections (100 milligram per milliliter [mg/mL]) of 1 milliliter (mL) each at two different quadrants of the abdomen; 1 injection per quadrant. Participants were followed up to Day 85. | | OG001 | PF-04950615 SC 200 mg (1 Injection of 2 mL) | Participants received single SC dose of PF-04950615 200 mg on Day 1; 1 injection (100 mg/mL) of 2 mL. Participants were followed up to Day 85. | | OG002 | PF-04950615 SC 100 mg (1 Injection of 1 mL) | Participants received single SC dose of PF-04950615 100 mg on Day 1; 1 injection (100 mg/mL) of 1 mL. Participants were followed up to Day 85. |
|
| Other Pre-specified | Visual Analogue Scale (VAS) | Participants indicated the amount of pain experienced due to study drug injection, on a VAS of 0 (no pain) to 100 (very severe pain), where higher scores indicate higher intensity of pain. | Safety analysis set included all participants who had at least 1 dose of study medication. Here, "Number of Participants Analyzed" signifies number of participants evaluable at different time points. | Posted | | Mean | Standard Deviation | units on a scale | | Day 1: Immediately post-dose, 0.5, 1.0, 2.0, 8.0 hours post-dose; Day 2, 3 | | | | ID | Title | Description |
|---|
| OG000 | PF-04950615 SC 200 mg (2 Injections of 1mL): Injection 1 | Participants received single SC dose of PF-04950615 200 mg on Day 1; 1 injection (100 mg/mL) of 1 mL at one quadrant of the two quadrants in abdomen. Participants were followed up to Day 85. | | OG001 | PF-04950615 SC 200 mg (2 Injections of 1mL): Injection 2 | Participants received single SC dose of PF-04950615 200 mg on Day 1; 1 injection (100 milligram per milliliter [mg/mL]) of 1 milliliter (mL) at second quadrant of the two quadrants in abdomen. Participants were followed up to Day 85. | | OG002 | PF-04950615 SC 200 mg (1 Injection of 2 mL) | Participants received single SC dose of PF-04950615 200 mg on Day 1; 1 injection (100 mg/mL) of 2 mL. Participants were followed up to Day 85. |
|
| Other Pre-specified | Number of Participants With Clinically Significant Laboratory Abnormalities | Laboratory parameters evaluated for abnormalities were: hematology (hemoglobin [Hgb], hematocrit, red blood cell [RBC] count, platelets, white blood cell count [WBC], lymphocytes, total neutrophils, basophils, eosinophils, monocytes); coagulation (partial thromboplastin time, prothrombin time [PT], PT international ratio); clinical chemistry (glucose, creatine kinase, amylase, lipase); liver function (total, direct and indirect bilirubin, aspartate aminotransferase [AT], alanine AT, gamma-glutamyl transferase, alkaline phosphatase, total protein, albumin, lactate dehydrogenase); renal function (blood urea nitrogen, creatinine, uric acid); urinalysis (urine- specific gravity, pH, glucose, ketones, blood/Hgb, nitrite, leukocyte, esterase, RBC, WBC, epithelial cells, hyaline cast and bacteria); lipid (cholesterol); electrolytes (sodium, potassium, chloride, calcium, magnesium, phosphate, bicarbonate). Clinical significance of laboratory abnormalities were judged by investigator. | Safety analysis set included all participants who had at least 1 dose of study medication. | Posted | | Count of Participants | | Participants | | Day 1 up to Day 85 | | | | ID | Title | Description |
|---|
| OG000 | PF-04950615 IV 200 mg | Participants received single intravenous (IV) infusion dose of PF-04950615 200 milligram (mg) on Day 1. Participants were followed up to Day 85. | | OG001 | PF-04950615 SC 200 mg (2 Injections of 1 mL) | |
|
| Other Pre-specified | Number of Participants With Clinically Significant Changes in Vital Signs | Vital signs abnormalities included: maximum increase or decrease from baseline in supine systolic blood pressure (BP) greater than or equal to (>=) 30 millimeter of mercury (mmHg); maximum increase or decrease from baseline in supine diastolic BP of >=20 mmHg; supine pulse rate less than (<) 40 beats per minute (bpm) and greater than (>) 120 bpm; standing pulse rate less than (<) 40 beats per minute (bpm) and greater than (>) 140 bpm. Clinical significance of vital signs were judged by investigator. | Safety analysis set included all participants who had at least 1 dose of study medication. | Posted | | Count of Participants | | Participants | | Day 1 up to Day 85 | | | | ID | Title | Description |
|---|
| OG000 | PF-04950615 IV 200 mg | Participants received single intravenous (IV) infusion dose of PF-04950615 200 milligram (mg) on Day 1. Participants were followed up to Day 85. | | OG001 | PF-04950615 SC 200 mg (2 Injections of 1 mL) | Participants received subcutaneous (SC) dose of PF-04950615 200 mg on Day 1; 2 injections (100 milligram per milliliter [mg/mL]) of 1 milliliter (mL) each at two different quadrants of the abdomen; 1 injection per quadrant. Participants were followed up to Day 85. | | OG002 | PF-04950615 SC 200 mg (1 Injection of 2 mL) |
|
| Other Pre-specified | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | ECG abnormalities included 1) PR interval: maximum >=300 maximum millisecond (msec), increase of >=25 percent (%) for baseline value of >200 msec and maximum increase of >=50% for baseline value of less than or equal to (<=) 200 msec; 2) QRS interval: maximum >=200 msec, maximum increase of >=25 % for baseline value of >100 msec and maximum increase of >=50% for baseline value of <=100 msec; 3) QT interval corrected using the Fridericia's formula (QTCF): 450 msec to <= 480 msec, 480 msec to <=500 msec, > 500 msec, maximum increase from baseline of >30 to <=60 msec and maximum increase from baseline of >60 msec. Clinical significance of ECG were judged by investigator. | Safety analysis set included all participants who had at least 1 dose of study medication. | Posted | | Count of Participants | | Participants | | Day 1 up to Day 85 | | | | ID | Title | Description |
|---|
| OG000 | PF-04950615 IV 200 mg | Participants received single intravenous (IV) infusion dose of PF-04950615 200 milligram (mg) on Day 1. Participants were followed up to Day 85. | | OG001 | PF-04950615 SC 200 mg (2 Injections of 1 mL) | Participants received subcutaneous (SC) dose of PF-04950615 200 mg on Day 1; 2 injections (100 milligram per milliliter [mg/mL]) of 1 milliliter (mL) each at two different quadrants of the abdomen; 1 injection per quadrant. Participants were followed up to Day 85. |
|
| Other Pre-specified | Percentage of Participants With Positive Anti-drug (Anti-PF 04950615) Antibodies | Human serum samples of participants who received PF-04950615 were analyzed for the presence of anti-PF-04950615 antibodies by using the semi quantitative enzyme-linked immunosorbent assay (ELISA). | Safety analysis set included all participants who had at least 1 dose of study medication. | Posted | | Number | | percentage of participants | | Day 1 up to Day 85 | | | | ID | Title | Description |
|---|
| OG000 | PF-04950615 IV 200 mg | Participants received single intravenous (IV) infusion dose of PF-04950615 200 milligram (mg) on Day 1. Participants were followed up to Day 85. | | OG001 | PF-04950615 SC 200 mg (2 Injections of 1 mL) | Participants received subcutaneous (SC) dose of PF-04950615 200 mg on Day 1; 2 injections (100 milligram per milliliter [mg/mL]) of 1 milliliter (mL) each at two different quadrants of the abdomen; 1 injection per quadrant. Participants were followed up to Day 85. | | OG002 | PF-04950615 SC 200 mg (1 Injection of 2 mL) | Participants received single SC dose of PF-04950615 200 mg on Day 1; 1 injection (100 mg/mL) of 2 mL. Participants were followed up to Day 85. |
|