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CompletedNCT02211261Updated Oct 16, 2018Results posted

A Phase 1 Single/Multiple Dose Study Of PF-06293620 To Assess Safety, Tolerability And Pharmacokinetics In Subjects With Type 2 Diabetes Mellitus

A Phase 1 interventional study of PF-06293620 and Placebo in Type 2 Diabetes Mellitus, sponsored by Pfizer. Completed at 7 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-10-16.

Sponsored by Pfizer · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

A first in human study to determine the safety, tolerability and pharmacokinetics of single and multiple ascending doses of PF-06293620 in subjects with Type 2 Diabetes Mellitus

02

Conditions studied

  • Type 2 Diabetes Mellitus

Keywords

  • first in human
  • single dose
  • multiple dose
  • escalation
  • safety study
  • Type 2 Diabetes Mellitus
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 84 is close to the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Men and women of non-childbearing potential with Type 2 Diabetes Mellitus
  • Subjects on stable doses of metformin >/= 1500 mg daily (SAD cohorts) or >/= 1000 mg daily (MAD cohorts) x 30 days prior to screening
  • HbA1c 7-10% (SAD Cohorts) or 6.5-10% (MAD cohorts) inclusive at screening
  • Fasting C-peptide >1.12 ng/mL (SAD cohorts) or >/= 0.8 mg/mL (MAD cohorts) at screening

Exclusion criteria

Exclusion Criteria:

  • History of Type 1 diabetes mellitus
  • Evidence of diabetic complications with significant end-organ damage
  • History of chronic pancreatitis or at high risk for pancreatitis
  • Poorly controlled hypertension
  • History of cardiovascular or cerebrovascular event or procedure
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
84 participants (actual)

Study arms

  • Experimental
    Cohort 1-PF-06293620 or placebo

    Single Ascending Dose PF-06293620 or placebo

    Biological: PF-06293620 · Biological: Placebo

  • Experimental
    Cohort 2-PF-06293620 or placebo

    Single Ascending Dose PF-06293620 or placebo

    Biological: PF-06293620 · Biological: Placebo

  • Experimental
    Cohort 3-PF-06293620 or placebo

    Single Ascending Dose PF-06293620 or placebo

    Biological: PF-06293620 · Biological: Placebo

  • Experimental
    Cohort 4-PF-06293620 or placebo

    Single Ascending Dose PF-06293620 or placebo

    Biological: PF-06293620 · Biological: Placebo

  • Experimental
    Cohort 5-PF-06293620 or placebo

    Single Ascending Dose PF-06293620 or placebo

    Biological: PF-06293620 · Biological: Placebo

  • Experimental
    Cohort 6-PF-06293620 or placebo

    Multiple Ascending Dose PF-06293620 or placebo

    Biological: PF-06293620 · Biological: Placebo

  • Experimental
    Cohort 7 PF-06293620 or placebo

    Multiple Ascending Dose PF-06293620 or placebo

    Biological: PF-06293620 · Biological: Placebo

  • Experimental
    Cohort 8-PF-06293620 or placebo

    Multiple Ascending Dose PF-06293620 or placebo

    Biological: PF-06293620 · Biological: Placebo

  • Experimental
    Cohort 9-PF-06293620 or placebo

    Multiple Ascending Dose PF-06293620 or placebo

    Biological: PF-06293620 · Biological: Placebo

Interventions

  • BiologicalPF-06293620

    subcutaneous, single dose 0.3 mg/kg

  • BiologicalPlacebo

    Subcutaneous normal saline single dose

  • BiologicalPF-06293620

    Subcutaneous, single dose 1.0 mg/kg

  • BiologicalPlacebo

    Subcutaneous normal saline single dose

  • BiologicalPF-06293620

    Subcutaneous single dose 3 mg/kg

  • BiologicalPlacebo

    Subcutaneous normal saline single dose

  • BiologicalPF-06293620

    Subcutaneous single dose 6 mg/kg

  • BiologicalPlacebo

    Subcutaneous normal saline single dose

  • BiologicalPF-06293620

    Intravenous infusion single dose 1 mg/kg

  • BiologicalPlacebo

    Intravenous infusion normal saline single dose

  • BiologicalPF-06293620

    Subcutaneous injection multiple dose 75 mg (Days 1, 29 and 57)

  • BiologicalPlacebo

    Subcutaneous injection normal saline multiple dose (Days 1, 29 and 57)

  • BiologicalPF-06293620

    Subcutaneous injection multiple dose 150 mg (Days 1, 29 and 57)

  • BiologicalPlacebo

    Subcutaneous injection normal saline multiple dose (Days 1, 29 and 57)

  • BiologicalPF-06293620

    Subcutaneous injection multiple dose 250 mg (Days 1, 29 and 57)

  • BiologicalPlacebo

    Subcutaneous injection normal saline multiple dose (Days 1, 29 and 57)

  • BiologicalPF-06293620

    Subcutaneous injection multiple dose TBD mg (Days TBD)

  • BiologicalPlacebo

    Subcutaneous injection normal saline multiple dose (Days TBD)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

  2. 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.

    Time frame: Days 1 to 85 for SAD cohorts; Days 1 to 169 for MAD Cohorts

  3. 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.

    Time frame: Days 1 to 85 for SAD cohorts; Days 1 to 169 for MAD Cohorts

Secondary outcomes

  1. 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.

    Time frame: 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

  2. 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.

    Time frame: 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

  3. 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.

    Time frame: 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

  4. 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.

    Time frame: 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

  5. 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.

    Time frame: 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

  6. 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.

    Time frame: 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

  7. Maximum Serum Concentration (Cmax) of PF-06293620 (SAD Cohorts)

    Maximum serum concentration (Cmax) of PF-06293620 was observed directly from data.

    Time frame: 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

  8. 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.

    Time frame: 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

  9. 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.

    Time frame: 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

  10. 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.

    Time frame: 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

  11. 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.

    Time frame: 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

  12. 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.

    Time frame: 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

  13. Maximum Serum Concentration (Cmax) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration

    Time frame: 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

  14. 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).

    Time frame: 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

  15. Lowest Concentration Observed During the Dosing Interval (Cmin) of PF-06293620 (MAD Cohorts) After Day 57 Administration

    Time frame: Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169

  16. 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.

    Time frame: 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

  17. 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).

    Time frame: Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169

  18. 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.

    Time frame: Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169

  19. 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.

    Time frame: Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169

  20. 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).

    Time frame: 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

  21. 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).

    Time frame: 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

07

Results

Posted Oct 16, 2018
Limitations and caveats
Originally planned 250 mg cohort was not enrolled in MAD part, because 150 mg cohort already demonstrated optimal glucose-lowering effect. Protocol-specified TBD (to be determined) dose level was 50 mg as well as expansion of the 75 mg cohort.

Participant flow

Participant flow — Overall Study
MilestonePlacebo SC (SAD Cohorts)PF-06293620 0.3 mg/kg SC (SAD Cohorts)PF-06293620 1.0 mg/kg SC (SAD Cohorts)PF-06293620 3.0 mg/kg SC (SAD Cohorts)PF-06293620 6.0 mg/kg SC (SAD Cohorts)Placebo IV (SAD Cohorts)PF-06293620 1.0 mg/kg IV (SAD Cohorts)Placebo SC (MAD Cohorts)PF-06293620 50 mg SC (MAD Cohorts)PF-06293620 75 mg SC (MAD Cohorts)PF-06293620 150 mg SC (MAD Cohorts)
Started966692688168
Completed965671678148
Not completed00102101020
Withdrew: Withdrawal by subject00102000000
Withdrew: Other00000100020
Withdrew: Lost to follow-up00000001000

Outcome measures

PrimaryNumber 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.

Time frame:
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.
Reported as:
Number · participants
Number of Participants With All-Causality and Treatment Related Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events
participantsPlacebo SC (SAD Cohorts)PF-06293620 0.3 mg/kg SC (SAD Cohorts)PF-06293620 1.0 mg/kg SC (SAD Cohorts)PF-06293620 3.0 mg/kg SC (SAD Cohorts)PF-06293620 6.0 mg/kg SC (SAD Cohorts)Placebo IV (SAD Cohorts)PF-06293620 1.0 mg/kg IV (SAD Cohorts)Placebo SC (MAD Cohorts)PF-06293620 50 mg SC (MAD Cohorts)PF-06293620 75 mg SC (MAD Cohorts)PF-06293620 150 mg SC (MAD Cohorts)
All-causality AE533550344118
All-causality SAE01000000012
Treatment-related AE10033011145
Treatment-related SAE00000000000
PrimaryNumber 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.

Time frame:
Days 1 to 85 for SAD cohorts; Days 1 to 169 for MAD Cohorts

No measurements were reported for this outcome.

PrimaryNumber 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.

Time frame:
Days 1 to 85 for SAD cohorts; Days 1 to 169 for MAD Cohorts
Reported as:
Number · participants
Number of Participants With Positive Anti-drug Antibody (ADA) Result
participantsPlacebo SC (SAD Cohorts)PF-06293620 0.3 mg/kg SC (SAD Cohorts)PF-06293620 1.0 mg/kg SC (SAD Cohorts)PF-06293620 3.0 mg/kg SC (SAD Cohorts)PF-06293620 6.0 mg/kg SC (SAD Cohorts)Placebo IV (SAD Cohorts)PF-06293620 1.0 mg/kg IV (SAD Cohorts)Placebo SC (MAD Cohorts)PF-06293620 50 mg SC (MAD Cohorts)PF-06293620 75 mg SC (MAD Cohorts)PF-06293620 150 mg SC (MAD Cohorts)
Number of Participants With Positive Anti-drug Antibody (ADA) Result15212010574
SecondaryArea 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.

Time frame:
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
Reported as:
Geometric mean · microgram*hour/milliliter (mcg*hr/mL)
Area Under the Serum Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06293620 (SAD Cohorts)
microgram*hour/milliliter (mcg*hr/mL)PF-06293620 0.3 mg/kg SC (SAD Cohorts)PF-06293620 1.0 mg/kg SC (SAD Cohorts)PF-06293620 3.0 mg/kg SC (SAD Cohorts)PF-06293620 6.0 mg/kg SC (SAD Cohorts)PF-06293620 1.0 mg/kg IV (SAD Cohorts)
Area Under the Serum Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06293620 (SAD Cohorts)300 ± NA1716 ± 466306 ± 5419440 ± 566775 ± 12
SecondaryDose-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.

Time frame:
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
Reported as:
Geometric mean · mcg*hr/mL/mg
Dose-normalized AUCinf (AUCinf(dn)) of PF-06293620 (SAD Cohorts)
mcg*hr/mL/mgPF-06293620 0.3 mg/kg SC (SAD Cohorts)PF-06293620 1.0 mg/kg SC (SAD Cohorts)PF-06293620 3.0 mg/kg SC (SAD Cohorts)PF-06293620 6.0 mg/kg SC (SAD Cohorts)PF-06293620 1.0 mg/kg IV (SAD Cohorts)
Dose-normalized AUCinf (AUCinf(dn)) of PF-06293620 (SAD Cohorts)12.00 ± NA22.24 ± 4523.79 ± 4736.13 ± 4967.94 ± 16
Statistical analysis
  • PF-06293620 0.3 mg/kg SC (SAD Cohorts) vs PF-06293620 1.0 mg/kg IV (SAD Cohorts) · Percentage of test relative to reference: 17.66 · 90% CI 8.44 to 36.95PF-06293620 0.3 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.
  • PF-06293620 1.0 mg/kg SC (SAD Cohorts) vs PF-06293620 1.0 mg/kg IV (SAD Cohorts) · Percentage of test relative to reference: 32.73 · 90% CI 21.64 to 49.51PF-06293620 1.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.
  • PF-06293620 3.0 mg/kg SC (SAD Cohorts) vs PF-06293620 1.0 mg/kg IV (SAD Cohorts) · Percentage of test relative to reference: 35.02 · 90% CI 23.60 to 51.95PF-06293620 3.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.
  • PF-06293620 6.0 mg/kg SC (SAD Cohorts) vs PF-06293620 1.0 mg/kg IV (SAD Cohorts) · Percentage of test relative to reference: 53.18 · 90% CI 36.36 to 77.78PF-06293620 6.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.
SecondaryArea 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.

Time frame:
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
Reported as:
Geometric mean · mcg*hr/mL
Area Under the Serum Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06293620 (SAD Cohorts)
mcg*hr/mLPF-06293620 0.3 mg/kg SC (SAD Cohorts)PF-06293620 1.0 mg/kg SC (SAD Cohorts)PF-06293620 3.0 mg/kg SC (SAD Cohorts)PF-06293620 6.0 mg/kg SC (SAD Cohorts)PF-06293620 1.0 mg/kg IV (SAD Cohorts)
Area Under the Serum Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06293620 (SAD Cohorts)128.3 ± 541619 ± 465945 ± 5318080 ± 586509 ± 13
SecondaryDose-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.

Time frame:
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
Reported as:
Geometric mean · mcg*hr/mL/mg
Dose-normalized AUClast (AUClast(dn)) of PF-06293620 (SAD Cohorts)
mcg*hr/mL/mgPF-06293620 0.3 mg/kg SC (SAD Cohorts)PF-06293620 1.0 mg/kg SC (SAD Cohorts)PF-06293620 3.0 mg/kg SC (SAD Cohorts)PF-06293620 6.0 mg/kg SC (SAD Cohorts)PF-06293620 1.0 mg/kg IV (SAD Cohorts)
Dose-normalized AUClast (AUClast(dn)) of PF-06293620 (SAD Cohorts)4.779 ± 5821.01 ± 4422.47 ± 4733.59 ± 5065.26 ± 18
Statistical analysis
  • PF-06293620 0.3 mg/kg SC (SAD Cohorts) vs PF-06293620 1.0 mg/kg IV (SAD Cohorts) · Percentage of test relative to reference: 7.32 · 90% CI 4.70 to 11.40PF-06293620 0.3 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.
  • PF-06293620 1.0 mg/kg SC (SAD Cohorts) vs PF-06293620 1.0 mg/kg IV (SAD Cohorts) · Percentage of test relative to reference: 32.19 · 90% CI 20.67 to 50.12PF-06293620 1.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.
  • PF-06293620 3.0 mg/kg SC (SAD Cohorts) vs PF-06293620 1.0 mg/kg IV (SAD Cohorts) · Percentage of test relative to reference: 34.43 · 90% CI 22.57 to 52.52PF-06293620 3.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.
  • PF-06293620 6.0 mg/kg SC (SAD Cohorts) vs PF-06293620 1.0 mg/kg IV (SAD Cohorts) · Percentage of test relative to reference: 51.47 · 90% CI 34.26 to 77.31PF-06293620 6.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.
SecondaryClearance (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.

Time frame:
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
Reported as:
Geometric mean · mL/hr
Clearance (CL) of PF-06293620 (SAD Cohorts)
mL/hrPF-06293620 1.0 mg/kg IV (SAD Cohorts)
Clearance (CL) of PF-06293620 (SAD Cohorts)14.72 ± 16
SecondaryApparent 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.

Time frame:
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
Reported as:
Geometric mean · mL/hr
Apparent Clearance (CL/F) of PF-06293620 (SAD Cohorts)
mL/hrPF-06293620 0.3 mg/kg SC (SAD Cohorts)PF-06293620 1.0 mg/kg SC (SAD Cohorts)PF-06293620 3.0 mg/kg SC (SAD Cohorts)PF-06293620 6.0 mg/kg SC (SAD Cohorts)
Apparent Clearance (CL/F) of PF-06293620 (SAD Cohorts)83.20 ± NA44.93 ± 4542.05 ± 4727.67 ± 49
SecondaryMaximum Serum Concentration (Cmax) of PF-06293620 (SAD Cohorts)

Maximum serum concentration (Cmax) of PF-06293620 was observed directly from data.

Time frame:
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
Reported as:
Geometric mean · mcg/mL
Maximum Serum Concentration (Cmax) of PF-06293620 (SAD Cohorts)
mcg/mLPF-06293620 0.3 mg/kg SC (SAD Cohorts)PF-06293620 1.0 mg/kg SC (SAD Cohorts)PF-06293620 3.0 mg/kg SC (SAD Cohorts)PF-06293620 6.0 mg/kg SC (SAD Cohorts)PF-06293620 1.0 mg/kg IV (SAD Cohorts)
Maximum Serum Concentration (Cmax) of PF-06293620 (SAD Cohorts)0.3907 ± 582.896 ± 487.222 ± 5222.30 ± 6227.64 ± 20
SecondaryTime 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.

Time frame:
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
Reported as:
Median · hours
Time for Maximum Serum Concentration (Tmax) of PF-06293620 (SAD Cohorts)
hoursPF-06293620 0.3 mg/kg SC (SAD Cohorts)PF-06293620 1.0 mg/kg SC (SAD Cohorts)PF-06293620 3.0 mg/kg SC (SAD Cohorts)PF-06293620 6.0 mg/kg SC (SAD Cohorts)PF-06293620 1.0 mg/kg IV (SAD Cohorts)
Time for Maximum Serum Concentration (Tmax) of PF-06293620 (SAD Cohorts)168 ± 58168 ± 48252 ± 52168 ± 621.00 ± 20
SecondarySteady-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.

Time frame:
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
Reported as:
Geometric mean · liters
Steady-state Volume of Distribution (Vss) of PF-06293620 (SAD Cohorts)
litersPF-06293620 1.0 mg/kg IV (SAD Cohorts)
Steady-state Volume of Distribution (Vss) of PF-06293620 (SAD Cohorts)7.095 ± 21
SecondaryApparent 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.

Time frame:
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
Reported as:
Geometric mean · liters
Apparent Volume of Distribution (Vz/F) of PF-06293620 (SAD Cohorts)
litersPF-06293620 0.3 mg/kg SC (SAD Cohorts)PF-06293620 1.0 mg/kg SC (SAD Cohorts)PF-06293620 3.0 mg/kg SC (SAD Cohorts)PF-06293620 6.0 mg/kg SC (SAD Cohorts)
Apparent Volume of Distribution (Vz/F) of PF-06293620 (SAD Cohorts)21.10 ± NA16.25 ± 4320.63 ± 4418.17 ± 48
SecondaryTerminal 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.

Time frame:
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
Reported as:
Mean · days
Terminal Elimination Half-life (Thalf) of PF-06293620 (SAD Cohorts)
daysPF-06293620 0.3 mg/kg SC (SAD Cohorts)PF-06293620 1.0 mg/kg SC (SAD Cohorts)PF-06293620 3.0 mg/kg SC (SAD Cohorts)PF-06293620 6.0 mg/kg SC (SAD Cohorts)PF-06293620 1.0 mg/kg IV (SAD Cohorts)
Terminal Elimination Half-life (Thalf) of PF-06293620 (SAD Cohorts)7.33 ± NA10.95 ± 3.7414.66 ± 4.2119.23 ± 3.4514.37 ± 3.13
SecondaryArea 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.

Time frame:
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
Reported as:
Geometric mean · mcg*hr/mL
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
mcg*hr/mLPF-06293620 50 mg SC (MAD Cohorts)PF-06293620 75 mg SC (MAD Cohorts)PF-06293620 150 mg SC (MAD Cohorts)
Day 1609.6 ± 137802.5 ± 792752 ± 73
Day 571309 ± 602991 ± 576121 ± 48
SecondaryMaximum Serum Concentration (Cmax) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration
Time frame:
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
Reported as:
Geometric mean · mcg/mL
Maximum Serum Concentration (Cmax) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration
mcg/mLPF-06293620 50 mg SC (MAD Cohorts)PF-06293620 75 mg SC (MAD Cohorts)PF-06293620 150 mg SC (MAD Cohorts)
Day 11.526 ± 1391.706 ± 725.184 ± 73
Day 571.989 ± 1836.012 ± 6511.74 ± 56
SecondaryAverage 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).

Time frame:
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
Reported as:
Geometric mean · mcg/mL
Average Concentration (Cav) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration
mcg/mLPF-06293620 50 mg SC (MAD Cohorts)PF-06293620 75 mg SC (MAD Cohorts)PF-06293620 150 mg SC (MAD Cohorts)
Day 10.9067 ± 1371.194 ± 794.096 ± 73
Day 571.948 ± 604.449 ± 579.102 ± 48
SecondaryLowest Concentration Observed During the Dosing Interval (Cmin) of PF-06293620 (MAD Cohorts) After Day 57 Administration
Time frame:
Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
Reported as:
Geometric mean · µg/mL
Lowest Concentration Observed During the Dosing Interval (Cmin) of PF-06293620 (MAD Cohorts) After Day 57 Administration
µg/mLPF-06293620 50 mg SC (MAD Cohorts)PF-06293620 75 mg SC (MAD Cohorts)PF-06293620 150 mg SC (MAD Cohorts)
Lowest Concentration Observed During the Dosing Interval (Cmin) of PF-06293620 (MAD Cohorts) After Day 57 Administration0.7555 ± 941.979 ± 725.456 ± 48
SecondaryTime 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.

Time frame:
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
Reported as:
Median · hours
Time for Maximum Serum Concentration (Tmax) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration
hoursPF-06293620 50 mg SC (MAD Cohorts)PF-06293620 75 mg SC (MAD Cohorts)PF-06293620 150 mg SC (MAD Cohorts)
Day 1240 (144 to 338)252 (48.0 to 338)360 (144 to 648)
Day 57168 (47.8 to 192)144 (47.5 to 648)120 (48.0 to 504)
SecondaryApparent 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).

Time frame:
Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
Reported as:
Geometric mean · mL/hr
Apparent Clearance (CL/F) of PF-06293620 (MAD Cohorts) After Day 57 Administration
mL/hrPF-06293620 50 mg SC (MAD Cohorts)PF-06293620 75 mg SC (MAD Cohorts)PF-06293620 150 mg SC (MAD Cohorts)
Apparent Clearance (CL/F) of PF-06293620 (MAD Cohorts) After Day 57 Administration38.19 ± 6025.07 ± 5724.53 ± 47
SecondaryApparent 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.

Time frame:
Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
Reported as:
Geometric mean · liters
Apparent Volume of Distribution (Vz/F) of PF-06293620 (MAD Cohorts) After Day 57 Administration
litersPF-06293620 50 mg SC (MAD Cohorts)PF-06293620 75 mg SC (MAD Cohorts)PF-06293620 150 mg SC (MAD Cohorts)
Apparent Volume of Distribution (Vz/F) of PF-06293620 (MAD Cohorts) After Day 57 Administration13.43 ± 3810.45 ± 5212.09 ± 40
SecondaryTerminal 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.

Time frame:
Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
Reported as:
Mean · days
Terminal Elimination Half-life (Thalf) of PF-06293620 (MAD Cohorts) After Day 57 Administration
daysPF-06293620 50 mg SC (MAD Cohorts)PF-06293620 75 mg SC (MAD Cohorts)PF-06293620 150 mg SC (MAD Cohorts)
Terminal Elimination Half-life (Thalf) of PF-06293620 (MAD Cohorts) After Day 57 Administration10.37 ± 2.2212.72 ± 4.2114.50 ± 2.81
SecondaryObserved 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).

Time frame:
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
Reported as:
Geometric mean · ratio
Observed Accumulation Ratio Based on AUC (Rac) of PF-06293620 (MAD Cohorts)
ratioPF-06293620 50 mg SC (MAD Cohorts)PF-06293620 75 mg SC (MAD Cohorts)PF-06293620 150 mg SC (MAD Cohorts)
Observed Accumulation Ratio Based on AUC (Rac) of PF-06293620 (MAD Cohorts)1.833 ± 643.446 ± 362.148 ± 30
SecondaryObserved 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).

Time frame:
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
Reported as:
Geometric mean · ratio
Observed Accumulation Ratio Based on Cmax (Rac,Cmax) of PF-06293620 (MAD Cohorts)
ratioPF-06293620 50 mg SC (MAD Cohorts)PF-06293620 75 mg SC (MAD Cohorts)PF-06293620 150 mg SC (MAD Cohorts)
Observed Accumulation Ratio Based on Cmax (Rac,Cmax) of PF-06293620 (MAD Cohorts)1.302 ± 1143.257 ± 422.188 ± 22

Adverse events

Collected over 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.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo SC (SAD Cohorts)0/9 (0%)0/9 (0%)5/9 (55.6%)
PF-06293620 0.3 mg/kg SC (SAD Cohorts)0/6 (0%)1/6 (16.7%)3/6 (50%)
PF-06293620 1.0 mg/kg SC (SAD Cohorts)0/6 (0%)0/6 (0%)3/6 (50%)
PF-06293620 3.0 mg/kg SC (SAD Cohorts)0/6 (0%)0/6 (0%)5/6 (83.3%)
PF-06293620 6.0 mg/kg SC (SAD Cohorts)0/9 (0%)0/9 (0%)5/9 (55.6%)
Placebo IV (SAD Cohorts)0/2 (0%)0/2 (0%)0/2 (0%)
PF-06293620 1.0 mg/kg IV (SAD Cohorts)0/6 (0%)0/6 (0%)3/6 (50%)
Placebo SC (MAD Cohorts)0/8 (0%)0/8 (0%)4/8 (50%)
PF-06293620 50 mg SC (MAD Cohorts)0/8 (0%)0/8 (0%)4/8 (50%)
PF-06293620 75 mg SC (MAD Cohorts)0/16 (0%)1/16 (6.3%)11/16 (68.8%)
PF-06293620 150 mg SC (MAD Cohorts)0/8 (0%)2/8 (25%)7/8 (87.5%)
Most frequent serious events
Most frequent serious events
EventPlacebo SC (SAD Cohorts)PF-06293620 0.3 mg/kg SC (SAD Cohorts)PF-06293620 1.0 mg/kg SC (SAD Cohorts)PF-06293620 3.0 mg/kg SC (SAD Cohorts)PF-06293620 6.0 mg/kg SC (SAD Cohorts)Placebo IV (SAD Cohorts)PF-06293620 1.0 mg/kg IV (SAD Cohorts)Placebo SC (MAD Cohorts)PF-06293620 50 mg SC (MAD Cohorts)PF-06293620 75 mg SC (MAD Cohorts)PF-06293620 150 mg SC (MAD Cohorts)
CholelithiasisHepatobiliary disorders0/91/60/60/60/90/20/60/80/80/160/8
Angina unstableCardiac disorders0/90/60/60/60/90/20/60/80/80/81/8
Coronary artery diseaseCardiac disorders0/90/60/60/60/90/20/60/80/80/161/8
Joint injuryInjury, poisoning and procedural complications0/90/60/60/60/90/20/60/80/81/160/8
Most frequent other events
Showing 10 of 60
Most frequent other events
EventPlacebo SC (SAD Cohorts)PF-06293620 0.3 mg/kg SC (SAD Cohorts)PF-06293620 1.0 mg/kg SC (SAD Cohorts)PF-06293620 3.0 mg/kg SC (SAD Cohorts)PF-06293620 6.0 mg/kg SC (SAD Cohorts)Placebo IV (SAD Cohorts)PF-06293620 1.0 mg/kg IV (SAD Cohorts)Placebo SC (MAD Cohorts)PF-06293620 50 mg SC (MAD Cohorts)PF-06293620 75 mg SC (MAD Cohorts)PF-06293620 150 mg SC (MAD Cohorts)
Liver function test increasedInvestigations1/91/60/61/62/90/21/60/80/81/165/8
DiarrhoeaGastrointestinal disorders2/90/60/63/60/90/20/61/80/82/160/8
Iron deficiency anaemiaBlood and lymphatic system disorders0/90/60/60/60/90/20/60/80/80/163/8
EcchymosisSkin and subcutaneous tissue disorders2/91/60/62/60/90/20/61/80/80/161/8
FallInjury, poisoning and procedural complications3/90/60/60/60/90/20/60/80/80/160/8
VomitingGastrointestinal disorders0/91/60/60/60/90/20/60/80/80/160/8
AstheniaGeneral disorders0/90/60/61/60/90/20/60/80/80/160/8
HungerGeneral disorders0/90/60/60/60/90/21/60/80/80/160/8
Infusion site extravasationGeneral disorders0/91/60/60/60/90/20/60/80/80/160/8
Infusion site hemorrhageGeneral disorders0/90/60/60/60/90/21/60/80/80/160/8

Baseline characteristics

Baseline analysis population included all participants enrolled.

Age, Customized
Age, Customized(participants)Placebo SC (SAD Cohorts)PF-06293620 0.3 mg/kg SC (SAD Cohorts)PF-06293620 1.0 mg/kg SC (SAD Cohorts)PF-06293620 3.0 mg/kg SC (SAD Cohorts)PF-06293620 6.0 mg/kg SC (SAD Cohorts)Placebo IV (SAD Cohorts)PF-06293620 1.0 mg/kg IV (SAD Cohorts)Placebo SC (MAD Cohorts)PF-06293620 50 mg SC (MAD Cohorts)PF-06293620 75 mg SC (MAD Cohorts)PF-06293620 150 mg SC (MAD Cohorts)Total
<18 years000000000000
18-44 years000011100003
45-64 years7446615749861
>=65 years2220200147020
Sex: Female, Male
Sex: Female, Male(Participants)Placebo SC (SAD Cohorts)PF-06293620 0.3 mg/kg SC (SAD Cohorts)PF-06293620 1.0 mg/kg SC (SAD Cohorts)PF-06293620 3.0 mg/kg SC (SAD Cohorts)PF-06293620 6.0 mg/kg SC (SAD Cohorts)Placebo IV (SAD Cohorts)PF-06293620 1.0 mg/kg IV (SAD Cohorts)Placebo SC (MAD Cohorts)PF-06293620 50 mg SC (MAD Cohorts)PF-06293620 75 mg SC (MAD Cohorts)PF-06293620 150 mg SC (MAD Cohorts)Total
Female5143400439134
Male4523526457750
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Placebo SC (SAD Cohorts)PF-06293620 0.3 mg/kg SC (SAD Cohorts)PF-06293620 1.0 mg/kg SC (SAD Cohorts)PF-06293620 3.0 mg/kg SC (SAD Cohorts)PF-06293620 6.0 mg/kg SC (SAD Cohorts)Placebo IV (SAD Cohorts)PF-06293620 1.0 mg/kg IV (SAD Cohorts)Placebo SC (MAD Cohorts)PF-06293620 50 mg SC (MAD Cohorts)PF-06293620 75 mg SC (MAD Cohorts)PF-06293620 150 mg SC (MAD Cohorts)Total
Hispanic or Latino6524324247746
Not Hispanic or Latino3142602649138
Unknown or Not Reported000000000000
08

Study locations

7 sites
  • Profil Institute for Clinical Research, Inc.
    Chula Vista, California 91911, United States
  • Profil Institute for Clinical Research, Incorporated
    Chula Vista, California 91911, United States
  • Avail Clinical Research, LLC
    DeLand, Florida 32720, United States
  • Orlando Clinical Research Center
    Orlando, Florida 32809, United States
  • Qps Mra, Llc
    South Miami, Florida 33143, United States
  • Qps-Mra Llc
    South Miami, Florida 33143, United States
  • High Point Clinical Trials Center, LLC
    High Point, North Carolina 27265, United States
09

References and documents

Study documents

  • Study protocol · Oct 2, 2015
  • Statistical analysis plan · Nov 8, 2016

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 16, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02211261
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Aug 7, 2014
Start date
Sep 15, 2014
Primary completion
Jan 27, 2017
Completion
Jan 27, 2017
Results posted
Oct 16, 2018
Last update
Oct 16, 2018

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

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