| Primary | Number of Participants With All-Causality and Treatment Related Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events | An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of its causal relationship with study treatment. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; was life-threatening (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study drug and up to Day 85 (for SAD cohorts) or Day 169 (for MAD cohorts) that were absent before treatment or that worsened after treatment. AEs included both serious and non-serious AEs. Causality with the study treatment was determined by the investigator. | The safety analysis population included all participants who received any amount of dose of study medication. | Posted | | Number | | participants | | Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit. | | | | ID | Title | Description |
|---|
| OG000 | Placebo SC (SAD Cohorts) | One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. | | OG001 | PF-06293620 0.3 mg/kg SC (SAD Cohorts) | One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. | | OG002 | PF-06293620 1.0 mg/kg SC (SAD Cohorts) | One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. | | OG003 | PF-06293620 3.0 mg/kg SC (SAD Cohorts) | One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. | | OG004 | PF-06293620 6.0 mg/kg SC (SAD Cohorts) | One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 6.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. | | OG005 | Placebo IV (SAD Cohorts) | One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours. |
| | | Title | Denominators | Categories |
|---|
| All-causality AE | | |
| |
| Primary | Number of Participants With Dose Limiting or Intolerable Adverse Events | Dose limiting or intolerable AEs were originally planned to be collected. However, this outcome measure was not actually summarized, since collection and monitoring of treatment-emergent AEs was performed during the study, and deemed sufficient to ensure the participants safety. | Data for this outcome measure were not collected. | Posted | | | | | | Days 1 to 85 for SAD cohorts; Days 1 to 169 for MAD Cohorts | | | | ID | Title | Description |
|---|
| OG000 | Placebo SC (SAD Cohorts) | One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. | | OG001 | PF-06293620 0.3 mg/kg SC (SAD Cohorts) | One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. | | OG002 | PF-06293620 1.0 mg/kg SC (SAD Cohorts) | One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. |
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| Primary | Number of Participants With Positive Anti-drug Antibody (ADA) Result | ADA against PF-06293620 in human serum samples was determined following a tiered approach using screening, confirmation, and titer/quantification by semi-quantitative enzyme linked immunosorbent assay (ELISA). Endpoint titer >=1.88 was considered positive. | The safety analysis population included all participants who received any amount of dose of study medication. | Posted | | Number | | participants | | Days 1 to 85 for SAD cohorts; Days 1 to 169 for MAD Cohorts | | | | ID | Title | Description |
|---|
| OG000 | Placebo SC (SAD Cohorts) | One group of participants in the single-ascending dose (SAD) cohorts received a single dose of placebo matched to PF-06293620 by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. | | OG001 | PF-06293620 0.3 mg/kg SC (SAD Cohorts) | One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. | | OG002 | PF-06293620 1.0 mg/kg SC (SAD Cohorts) | One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. |
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| Secondary | Area Under the Serum Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06293620 (SAD Cohorts) | AUCinf was calculated as AUClast +(Clast*/kel), where AUClast is area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast* is the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis, kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression. | The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | microgram*hour/milliliter (mcg*hr/mL) | | Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85 | | | | ID | Title | Description |
|---|
| OG000 | PF-06293620 0.3 mg/kg SC (SAD Cohorts) | One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. | | OG001 | PF-06293620 1.0 mg/kg SC (SAD Cohorts) | One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. |
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| Secondary | Dose-normalized AUCinf (AUCinf(dn)) of PF-06293620 (SAD Cohorts) | AUCinf(dn) was calculated as AUCinf/dose, where AUCinf is area under the serum concentration-time profile from time 0 extrapolated to infinite time. | The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mcg*hr/mL/mg | | Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85 | | | | ID | Title | Description |
|---|
| OG000 | PF-06293620 0.3 mg/kg SC (SAD Cohorts) | One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. | | OG001 | PF-06293620 1.0 mg/kg SC (SAD Cohorts) | One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. | | OG002 | PF-06293620 3.0 mg/kg SC (SAD Cohorts) | One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. |
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| Secondary | Area Under the Serum Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06293620 (SAD Cohorts) | Area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast) of PF-06293620 was determined using linear/log trapezoidal method. | The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mcg*hr/mL | | Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85 | | | | ID | Title | Description |
|---|
| OG000 | PF-06293620 0.3 mg/kg SC (SAD Cohorts) | One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. | | OG001 | PF-06293620 1.0 mg/kg SC (SAD Cohorts) | One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. | | OG002 | PF-06293620 3.0 mg/kg SC (SAD Cohorts) |
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| Secondary | Dose-normalized AUClast (AUClast(dn)) of PF-06293620 (SAD Cohorts) | AUClast(dn) of PF-06293620 was calculated as AUClast/dose, where AUClast was area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. | The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mcg*hr/mL/mg | | Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85 | | | | ID | Title | Description |
|---|
| OG000 | PF-06293620 0.3 mg/kg SC (SAD Cohorts) | One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. | | OG001 | PF-06293620 1.0 mg/kg SC (SAD Cohorts) | One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. | | OG002 | PF-06293620 3.0 mg/kg SC (SAD Cohorts) | One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. |
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| Secondary | Clearance (CL) of PF-06293620 (SAD Cohorts) | Clearance (CL) was calculated as dose/AUCinf, where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time. This outcome measure only applies to IV arms. | The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mL/hr | | Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85 | | | | ID | Title | Description |
|---|
| OG000 | PF-06293620 1.0 mg/kg IV (SAD Cohorts) | One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours. |
| |
| Secondary | Apparent Clearance (CL/F) of PF-06293620 (SAD Cohorts) | Apparent Clearance (CL/F) of PF-06293620 was calculated as dose/AUCinf, where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time. This outcome measure only applies to SC arms. | The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mL/hr | | Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85 | | | | ID | Title | Description |
|---|
| OG000 | PF-06293620 0.3 mg/kg SC (SAD Cohorts) | One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. | | OG001 | PF-06293620 1.0 mg/kg SC (SAD Cohorts) | One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. | | OG002 | PF-06293620 3.0 mg/kg SC (SAD Cohorts) | |
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| Secondary | Maximum Serum Concentration (Cmax) of PF-06293620 (SAD Cohorts) | Maximum serum concentration (Cmax) of PF-06293620 was observed directly from data. | The pharmacokinetic (PK) concentration population included all enrolled participants treated who had at least 1 measurable (greater than lower limit of quantification) concentration value. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mcg/mL | | Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85 | | | | ID | Title | Description |
|---|
| OG000 | PF-06293620 0.3 mg/kg SC (SAD Cohorts) | One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. | | OG001 | PF-06293620 1.0 mg/kg SC (SAD Cohorts) | One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. | | OG002 | PF-06293620 3.0 mg/kg SC (SAD Cohorts) | One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. |
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| Secondary | Time for Maximum Serum Concentration (Tmax) of PF-06293620 (SAD Cohorts) | Time for Maximum serum concentration (Tmax) of PF-06293620 was observed directly from data as time of first occurrence. | The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest. | Posted | | Median | Full Range | hours | | Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85 | | | | ID | Title | Description |
|---|
| OG000 | PF-06293620 0.3 mg/kg SC (SAD Cohorts) | One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. | | OG001 | PF-06293620 1.0 mg/kg SC (SAD Cohorts) | One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. | | OG002 | PF-06293620 3.0 mg/kg SC (SAD Cohorts) | One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 3.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. |
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| Secondary | Steady-state Volume of Distribution (Vss) of PF-06293620 (SAD Cohorts) | Steady-state volume of distribution (Vss) of PF-06293620 was calculated as CL*MRT, where MRT was the mean residence time calculated as (AUMCinf/AUCinf - infusion duration/2), AUMCinf was area under the moment curve from time 0 extrapolated to infinity; CL was the clearance. This outcome measure only applies to IV arms. | The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | liters | | Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85 | | | | ID | Title | Description |
|---|
| OG000 | PF-06293620 1.0 mg/kg IV (SAD Cohorts) | One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by intravenous (IV) infusion over approximately 60 minutes following an overnight fast of at least 10 hours. |
| |
| Secondary | Apparent Volume of Distribution (Vz/F) of PF-06293620 (SAD Cohorts) | Apparent Volume of Distribution (Vz/F) of PF-06293620 was calculated as dose/(AUCinf*kel), where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time, kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. This outcome measure only applies to SC arms. | The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | liters | | Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85 | | | | ID | Title | Description |
|---|
| OG000 | PF-06293620 0.3 mg/kg SC (SAD Cohorts) | One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. | | OG001 | PF-06293620 1.0 mg/kg SC (SAD Cohorts) | One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. | | OG002 |
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| Secondary | Terminal Elimination Half-life (Thalf) of PF-06293620 (SAD Cohorts) | Terminal elimination half-life (Thalf) of PF-06293620 was calculated as ln(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression. | The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest. | Posted | | Mean | Standard Deviation | days | | Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85 | | | | ID | Title | Description |
|---|
| OG000 | PF-06293620 0.3 mg/kg SC (SAD Cohorts) | One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 0.3 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. | | OG001 | PF-06293620 1.0 mg/kg SC (SAD Cohorts) | One group of participants in the single-ascending dose (SAD) cohorts received a single dose of PF-06293620 at 1.0 mg/kg by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. | | OG002 | PF-06293620 3.0 mg/kg SC (SAD Cohorts) |
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| Secondary | Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration | Tau refers to the dosing interval, which was 4 weeks (672 hours). Area under the concentration-time profile from time 0 to time tau (AUCtau) was determined using linear/log trapezoidal method. | The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mcg*hr/mL | | Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169 | | | | ID | Title | Description |
|---|
| OG000 | PF-06293620 50 mg SC (MAD Cohorts) | One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. | | OG001 | PF-06293620 75 mg SC (MAD Cohorts) | One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. |
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| Secondary | Maximum Serum Concentration (Cmax) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration | | The PK concentration population included all enrolled participants treated who had at least 1 measurable concentration value. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mcg/mL | | Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169 | | | | ID | Title | Description |
|---|
| OG000 | PF-06293620 50 mg SC (MAD Cohorts) | One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. | | OG001 | PF-06293620 75 mg SC (MAD Cohorts) | One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. | | OG002 | PF-06293620 150 mg SC (MAD Cohorts) | |
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| Secondary | Average Concentration (Cav) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration | Average Concentration (Cav) of PF-06293620 was calculated as AUCtau/tau, where AUCtau was area under the concentration-time profile from time 0 to time tau, and tau was the dosing interval, 4 weeks (672 hours). | The PK concentration population included all enrolled participants treated who had at least 1 measurable concentration value. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mcg/mL | | Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169 | | | | ID | Title | Description |
|---|
| OG000 | PF-06293620 50 mg SC (MAD Cohorts) | One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. | | OG001 | PF-06293620 75 mg SC (MAD Cohorts) | One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. |
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| Secondary | Lowest Concentration Observed During the Dosing Interval (Cmin) of PF-06293620 (MAD Cohorts) After Day 57 Administration | | The pharmacokinetic (PK) concentration population included all enrolled participants treated who had at least 1 measurable (greater than lower limit of quantification) concentration value. | Posted | | Geometric Mean | Geometric Coefficient of Variation | µg/mL | | Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169 | | | | ID | Title | Description |
|---|
| OG000 | PF-06293620 50 mg SC (MAD Cohorts) | One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. | | OG001 | PF-06293620 75 mg SC (MAD Cohorts) | One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. | | OG002 | PF-06293620 150 mg SC (MAD Cohorts) | One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 150 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. |
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| Secondary | Time for Maximum Serum Concentration (Tmax) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration | Time for maximum serum concentration (Tmax) of PF-06293620 was observed directly from data as time of first occurrence. | The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest. | Posted | | Median | Full Range | hours | | Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169 | | | | ID | Title | Description |
|---|
| OG000 | PF-06293620 50 mg SC (MAD Cohorts) | One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. | | OG001 | PF-06293620 75 mg SC (MAD Cohorts) | One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. | |
|
| Secondary | Apparent Clearance (CL/F) of PF-06293620 (MAD Cohorts) After Day 57 Administration | Apparent clearance (CL/F) of PF-06293620 was calculated as dose/AUCtau, where AUCtau was area under the concentration-time profile from time 0 to time tau, and tau was the dosing interval, 4 weeks (672 hours). | The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mL/hr | | Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169 | | | | ID | Title | Description |
|---|
| OG000 | PF-06293620 50 mg SC (MAD Cohorts) | One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. | | OG001 | PF-06293620 75 mg SC (MAD Cohorts) | One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. | | OG002 |
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| Secondary | Apparent Volume of Distribution (Vz/F) of PF-06293620 (MAD Cohorts) After Day 57 Administration | Apparent volume of distribution (Vz/F) of PF-06293620 was calculated as dose/(AUCtau/kel), where AUCtau was area under the concentration-time profile from time 0 to time tau, and tau was the dosing interval, 4 weeks (672 hours); and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression. | The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | liters | | Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169 | | | | ID | Title | Description |
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| OG000 | PF-06293620 50 mg SC (MAD Cohorts) | One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. | | OG001 | PF-06293620 75 mg SC (MAD Cohorts) | One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. |
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| Secondary | Terminal Elimination Half-life (Thalf) of PF-06293620 (MAD Cohorts) After Day 57 Administration | Terminal elimination half-life (Thalf) of PF-06293620 was calculated as ln(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression. | The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest. | Posted | | Mean | Standard Deviation | days | | Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169 | | | | ID | Title | Description |
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| OG000 | PF-06293620 50 mg SC (MAD Cohorts) | One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. | | OG001 | PF-06293620 75 mg SC (MAD Cohorts) | One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. |
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| Secondary | Observed Accumulation Ratio Based on AUC (Rac) of PF-06293620 (MAD Cohorts) | Observed accumulation ratio based on AUC (Rac) of PF-06293620 was calculated as AUCtau(Day57)/AUCtau(Day1). | The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ratio | | Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169 | | | | ID | Title | Description |
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| OG000 | PF-06293620 50 mg SC (MAD Cohorts) | One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. | | OG001 | PF-06293620 75 mg SC (MAD Cohorts) | One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. | | OG002 |
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| Secondary | Observed Accumulation Ratio Based on Cmax (Rac,Cmax) of PF-06293620 (MAD Cohorts) | Observed accumulation ratio based on Cmax (Rac,Cmax) of PF-06293620 was calculated as Cmax(Day57)/Cmax(Day1). | The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ratio | | Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169 | | | | ID | Title | Description |
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| OG000 | PF-06293620 50 mg SC (MAD Cohorts) | One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 50 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. | | OG001 | PF-06293620 75 mg SC (MAD Cohorts) | One group of participants in the multiple-ascending dose (MAD) cohorts received PF-06293620 75 mg every 4 weeks (on Days 1, 29 and 57, deviation of plus or minus 2 days was allowed for Day 29 and Day 57 dosing) by subcutaneous (SC) injection to the abdomen following an overnight fast of at least 10 hours. | | OG002 |
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