Trial Outcomes & Findings for A Pharmacokinetic and Pharmacodynamic Study of PF-04950615 (RN316) in Subjects With Hypercholesterolemia (NCT NCT01435382)

NCT ID: NCT01435382

Last Updated: 2018-07-23

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

49 participants

Primary outcome timeframe

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

Results posted on

2018-07-23

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.	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.	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.
Overall Study STARTED	12	13	13	11
Overall Study COMPLETED	11	11	12	10
Overall Study NOT COMPLETED	1	2	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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.	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.
Overall Study Lost to Follow-up	1	0	1	0
Overall Study Withdrawal by Subject	0	2	0	1

Baseline Characteristics

A Pharmacokinetic and Pharmacodynamic Study of PF-04950615 (RN316) in Subjects With Hypercholesterolemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PF-04950615 IV 200 mg n=12 Participants Participants received single intravenous (IV) infusion dose of PF-04950615 200 milligram (mg) on Day 1. Participants were followed up to Day 85.	PF-04950615 SC 200 mg (2 Injections of 1 mL) n=13 Participants 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.	PF-04950615 SC 200 mg (1 Injection of 2 mL) n=13 Participants 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.	PF-04950615 SC 100 mg (1 Injection of 1 mL) n=11 Participants 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.	Total n=49 Participants Total of all reporting groups
Age, Continuous	50.8 years STANDARD_DEVIATION 9.9 • n=5 Participants	55.6 years STANDARD_DEVIATION 9.8 • n=7 Participants	52.1 years STANDARD_DEVIATION 6.9 • n=5 Participants	53.2 years STANDARD_DEVIATION 12.3 • n=4 Participants	52.9 years STANDARD_DEVIATION 9.7 • n=21 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants	6 Participants n=4 Participants	21 Participants n=21 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	9 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	28 Participants n=21 Participants

PRIMARY outcome

Timeframe: 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

Population: Pharmacokinetic (PK) parameter analysis population included all participants randomized and treated who have at least 1 of the PK parameters of primary interest.

Outcome measures

Outcome measures
Measure	PF-04950615 IV 200 mg n=12 Participants Participants received single intravenous (IV) infusion dose of PF-04950615 200 milligram (mg) on Day 1. Participants were followed up to Day 85.	PF-04950615 SC 200 mg (2 Injections of 1 mL) n=13 Participants 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.	PF-04950615 SC 200 mg (1 Injection of 2 mL) n=13 Participants 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.	PF-04950615 SC 100 mg (1 Injection of 1 mL) n=11 Participants 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.
Maximum Observed Plasma Concentration (Cmax) of PF-04950615	65810 nanogram per milliliter (ng/mL) Standard Deviation 14047	15900 nanogram per milliliter (ng/mL) Standard Deviation 18289	8922 nanogram per milliliter (ng/mL) Standard Deviation 4016.4	10470 nanogram per milliliter (ng/mL) Standard Deviation 18219

PRIMARY outcome

Timeframe: 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

Population: PK parameter analysis population included all participants randomized and treated who have at least 1 of the PK parameters of primary interest.

Outcome measures

Outcome measures
Measure	PF-04950615 IV 200 mg n=12 Participants Participants received single intravenous (IV) infusion dose of PF-04950615 200 milligram (mg) on Day 1. Participants were followed up to Day 85.	PF-04950615 SC 200 mg (2 Injections of 1 mL) n=13 Participants 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.	PF-04950615 SC 200 mg (1 Injection of 2 mL) n=13 Participants 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.	PF-04950615 SC 100 mg (1 Injection of 1 mL) n=11 Participants 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.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04950615	1.00 hour Interval 1.0 to 1.08	95.2 hour Interval 8.0 to 167.0	96.0 hour Interval 71.0 to 167.0	72.0 hour Interval 8.0 to 504.0

PRIMARY outcome

Timeframe: 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

Population: 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.

Outcome measures

Outcome measures
Measure	PF-04950615 IV 200 mg n=11 Participants Participants received single intravenous (IV) infusion dose of PF-04950615 200 milligram (mg) on Day 1. Participants were followed up to Day 85.	PF-04950615 SC 200 mg (2 Injections of 1 mL) n=13 Participants 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.	PF-04950615 SC 200 mg (1 Injection of 2 mL) n=13 Participants 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.	PF-04950615 SC 100 mg (1 Injection of 1 mL) n=11 Participants 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.
Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of PF-04950615	13360000 nanogram*hour per milliliter Standard Deviation 3635200	3420000 nanogram*hour per milliliter Standard Deviation 2024100	2862000 nanogram*hour per milliliter Standard Deviation 1638000	1529000 nanogram*hour per milliliter Standard Deviation 849890

PRIMARY outcome

Timeframe: 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

Population: 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.

Outcome measures

Outcome measures
Measure	PF-04950615 IV 200 mg n=11 Participants Participants received single intravenous (IV) infusion dose of PF-04950615 200 milligram (mg) on Day 1. Participants were followed up to Day 85.	PF-04950615 SC 200 mg (2 Injections of 1 mL) n=10 Participants 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.	PF-04950615 SC 200 mg (1 Injection of 2 mL) n=11 Participants 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.	PF-04950615 SC 100 mg (1 Injection of 1 mL) n=7 Participants 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.
Area Under the Plasma Concentration-Time Curve From Time Zero To Infinity (AUCinf) of PF-04950615	13510000 nanogram*hour per milliliter Standard Deviation 3644400	3911000 nanogram*hour per milliliter Standard Deviation 2008600	3173000 nanogram*hour per milliliter Standard Deviation 1728000	1271000 nanogram*hour per milliliter Standard Deviation 411160

PRIMARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	PF-04950615 IV 200 mg n=10 Participants Participants received single intravenous (IV) infusion dose of PF-04950615 200 milligram (mg) on Day 1. Participants were followed up to Day 85.	PF-04950615 SC 200 mg (2 Injections of 1 mL) n=11 Participants 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.	PF-04950615 SC 200 mg (1 Injection of 2 mL) n=7 Participants 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.	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.
Apparent Clearance (CL/F) of PF-04950615 Subcutaneous Groups	71.64 milliliter per hour Standard Deviation 53.293	80.08 milliliter per hour Standard Deviation 42.654	85.54 milliliter per hour Standard Deviation 26.453	—

PRIMARY outcome

Timeframe: 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

Population: 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).

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.

Outcome measures

Outcome measures
Measure	PF-04950615 IV 200 mg n=11 Participants Participants received single intravenous (IV) infusion dose of PF-04950615 200 milligram (mg) on Day 1. Participants were followed up to Day 85.	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.	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.	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.
Clearance (CL) of PF-04950615 Intravenous Group	15.82 milliliter per hour Standard Deviation 4.3037	—	—	—

PRIMARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	PF-04950615 IV 200 mg n=10 Participants Participants received single intravenous (IV) infusion dose of PF-04950615 200 milligram (mg) on Day 1. Participants were followed up to Day 85.	PF-04950615 SC 200 mg (2 Injections of 1 mL) n=11 Participants 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.	PF-04950615 SC 200 mg (1 Injection of 2 mL) n=7 Participants 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.	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.
Apparent Volume of Distribution (Vz/F) of PF-04950615 Subcutaneous Groups	17770 milliliter Standard Deviation 13555	19400 milliliter Standard Deviation 19371	18400 milliliter Standard Deviation 6381.5	—

PRIMARY outcome

Timeframe: 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

Population: 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).

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.

Outcome measures

Outcome measures
Measure	PF-04950615 IV 200 mg n=11 Participants Participants received single intravenous (IV) infusion dose of PF-04950615 200 milligram (mg) on Day 1. Participants were followed up to Day 85.	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.	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.	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.
Volume of Distribution at Steady State (Vss) of PF-04950615 Intravenous Group	4232 milliliter Standard Deviation 757.77	—	—	—

PRIMARY outcome

Timeframe: 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

Population: 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.

t1/2 is the time measured for the plasma concentration of drug to decrease by one half.

Outcome measures

Outcome measures
Measure	PF-04950615 IV 200 mg n=11 Participants Participants received single intravenous (IV) infusion dose of PF-04950615 200 milligram (mg) on Day 1. Participants were followed up to Day 85.	PF-04950615 SC 200 mg (2 Injections of 1 mL) n=10 Participants 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.	PF-04950615 SC 200 mg (1 Injection of 2 mL) n=11 Participants 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.	PF-04950615 SC 100 mg (1 Injection of 1 mL) n=7 Participants 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.
Terminal Elimination Half-life (t1/2) of PF-04950615	202.4 hour Standard Deviation 76.391	187.6 hour Standard Deviation 87.298	153.2 hour Standard Deviation 49.106	152.6 hour Standard Deviation 43.324

PRIMARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	PF-04950615 IV 200 mg n=13 Participants Participants received single intravenous (IV) infusion dose of PF-04950615 200 milligram (mg) on Day 1. Participants were followed up to Day 85.	PF-04950615 SC 200 mg (2 Injections of 1 mL) n=13 Participants 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.	PF-04950615 SC 200 mg (1 Injection of 2 mL) n=11 Participants 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.	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.
Absolute Bioavailability of PF-04950615 Subcutaneous Groups	20.60 percentage of bioavailability Interval 13.74 to 30.87	21.24 percentage of bioavailability Interval 14.4 to 31.33	19.54 percentage of bioavailability Interval 13.25 to 28.83	—

SECONDARY outcome

Timeframe: Day 2, 3, 4, 5, 6, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 85

Population: 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.

Outcome measures

Outcome measures
Measure	PF-04950615 IV 200 mg n=12 Participants Participants received single intravenous (IV) infusion dose of PF-04950615 200 milligram (mg) on Day 1. Participants were followed up to Day 85.	PF-04950615 SC 200 mg (2 Injections of 1 mL) n=13 Participants 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.	PF-04950615 SC 200 mg (1 Injection of 2 mL) n=13 Participants 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.	PF-04950615 SC 100 mg (1 Injection of 1 mL) n=11 Participants 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.
Absolute Value of Fasting Low-density Lipoprotein Cholesterol (LDL-C) Day 22	60.27 milligram per deciliter (mg/dL) Standard Deviation 14.143	82.45 milligram per deciliter (mg/dL) Standard Deviation 38.508	72.85 milligram per deciliter (mg/dL) Standard Deviation 28.801	103.18 milligram per deciliter (mg/dL) Standard Deviation 32.230
Absolute Value of Fasting Low-density Lipoprotein Cholesterol (LDL-C) Day 29	65.82 milligram per deciliter (mg/dL) Standard Deviation 11.303	126.18 milligram per deciliter (mg/dL) Standard Deviation 45.683	115.75 milligram per deciliter (mg/dL) Standard Deviation 24.984	142.64 milligram per deciliter (mg/dL) Standard Deviation 23.243
Absolute Value of Fasting Low-density Lipoprotein Cholesterol (LDL-C) Day 71	151.00 milligram per deciliter (mg/dL) Standard Deviation 27.928	149.91 milligram per deciliter (mg/dL) Standard Deviation 32.473	148.00 milligram per deciliter (mg/dL) Standard Deviation 16.432	141.80 milligram per deciliter (mg/dL) Standard Deviation 26.561
Absolute Value of Fasting Low-density Lipoprotein Cholesterol (LDL-C) Day 2	154.00 milligram per deciliter (mg/dL) Standard Deviation 30.899	145.15 milligram per deciliter (mg/dL) Standard Deviation 29.653	148.31 milligram per deciliter (mg/dL) Standard Deviation 29.965	143.36 milligram per deciliter (mg/dL) Standard Deviation 24.250
Absolute Value of Fasting Low-density Lipoprotein Cholesterol (LDL-C) Day 3	147.33 milligram per deciliter (mg/dL) Standard Deviation 23.274	132.54 milligram per deciliter (mg/dL) Standard Deviation 27.933	138.31 milligram per deciliter (mg/dL) Standard Deviation 26.961	134.18 milligram per deciliter (mg/dL) Standard Deviation 26.294
Absolute Value of Fasting Low-density Lipoprotein Cholesterol (LDL-C) Day 4	131.09 milligram per deciliter (mg/dL) Standard Deviation 20.637	119.08 milligram per deciliter (mg/dL) Standard Deviation 31.481	125.77 milligram per deciliter (mg/dL) Standard Deviation 29.936	126.55 milligram per deciliter (mg/dL) Standard Deviation 27.883
Absolute Value of Fasting Low-density Lipoprotein Cholesterol (LDL-C) Day 5	126.67 milligram per deciliter (mg/dL) Standard Deviation 26.476	104.46 milligram per deciliter (mg/dL) Standard Deviation 33.301	116.46 milligram per deciliter (mg/dL) Standard Deviation 38.937	119.91 milligram per deciliter (mg/dL) Standard Deviation 31.995
Absolute Value of Fasting Low-density Lipoprotein Cholesterol (LDL-C) Day 6	128.92 milligram per deciliter (mg/dL) Standard Deviation 34.828	91.38 milligram per deciliter (mg/dL) Standard Deviation 26.355	101.31 milligram per deciliter (mg/dL) Standard Deviation 30.872	111.55 milligram per deciliter (mg/dL) Standard Deviation 29.733
Absolute Value of Fasting Low-density Lipoprotein Cholesterol (LDL-C) Day 8	96.70 milligram per deciliter (mg/dL) Standard Deviation 17.257	91.92 milligram per deciliter (mg/dL) Standard Deviation 40.016	93.85 milligram per deciliter (mg/dL) Standard Deviation 32.695	104.20 milligram per deciliter (mg/dL) Standard Deviation 20.896
Absolute Value of Fasting Low-density Lipoprotein Cholesterol (LDL-C) Day 15	68.73 milligram per deciliter (mg/dL) Standard Deviation 18.906	69.67 milligram per deciliter (mg/dL) Standard Deviation 25.115	69.83 milligram per deciliter (mg/dL) Standard Deviation 29.649	73.00 milligram per deciliter (mg/dL) Standard Deviation 26.069
Absolute Value of Fasting Low-density Lipoprotein Cholesterol (LDL-C) Day 36	74.73 milligram per deciliter (mg/dL) Standard Deviation 23.749	125.10 milligram per deciliter (mg/dL) Standard Deviation 34.962	133.75 milligram per deciliter (mg/dL) Standard Deviation 24.458	140.80 milligram per deciliter (mg/dL) Standard Deviation 25.529
Absolute Value of Fasting Low-density Lipoprotein Cholesterol (LDL-C) Day 43	96.00 milligram per deciliter (mg/dL) Standard Deviation 33.308	142.45 milligram per deciliter (mg/dL) Standard Deviation 33.255	140.75 milligram per deciliter (mg/dL) Standard Deviation 26.362	149.60 milligram per deciliter (mg/dL) Standard Deviation 27.261
Absolute Value of Fasting Low-density Lipoprotein Cholesterol (LDL-C) Day 50	119.64 milligram per deciliter (mg/dL) Standard Deviation 28.790	149.45 milligram per deciliter (mg/dL) Standard Deviation 49.178	152.17 milligram per deciliter (mg/dL) Standard Deviation 25.074	151.70 milligram per deciliter (mg/dL) Standard Deviation 29.691
Absolute Value of Fasting Low-density Lipoprotein Cholesterol (LDL-C) Day 57	150.20 milligram per deciliter (mg/dL) Standard Deviation 26.931	155.73 milligram per deciliter (mg/dL) Standard Deviation 35.755	152.25 milligram per deciliter (mg/dL) Standard Deviation 21.192	163.40 milligram per deciliter (mg/dL) Standard Deviation 38.839
Absolute Value of Fasting Low-density Lipoprotein Cholesterol (LDL-C) Day 64	155.27 milligram per deciliter (mg/dL) Standard Deviation 36.072	154.09 milligram per deciliter (mg/dL) Standard Deviation 30.164	148.33 milligram per deciliter (mg/dL) Standard Deviation 20.637	152.00 milligram per deciliter (mg/dL) Standard Deviation 32.139
Absolute Value of Fasting Low-density Lipoprotein Cholesterol (LDL-C) Day 85	159.82 milligram per deciliter (mg/dL) Standard Deviation 21.577	151.00 milligram per deciliter (mg/dL) Standard Deviation 26.461	153.50 milligram per deciliter (mg/dL) Standard Deviation 28.688	137.30 milligram per deciliter (mg/dL) Standard Deviation 18.325

SECONDARY outcome

Timeframe: Baseline, Day 2, 3, 4, 5, 6, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 85

Population: 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.

Baseline was the average of observations collected on Days 7 and 1 prior to the study treatment administration.

Outcome measures

Outcome measures
Measure	PF-04950615 IV 200 mg n=12 Participants Participants received single intravenous (IV) infusion dose of PF-04950615 200 milligram (mg) on Day 1. Participants were followed up to Day 85.	PF-04950615 SC 200 mg (2 Injections of 1 mL) n=13 Participants 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.	PF-04950615 SC 200 mg (1 Injection of 2 mL) n=13 Participants 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.	PF-04950615 SC 100 mg (1 Injection of 1 mL) n=11 Participants 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.
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 Day 5	-22.59 percent change Standard Deviation 11.972	-34.84 percent change Standard Deviation 13.442	-28.05 percent change Standard Deviation 16.909	-23.83 percent change Standard Deviation 14.811
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 Day 36	-55.43 percent change Standard Deviation 13.394	-20.45 percent change Standard Deviation 19.212	-15.45 percent change Standard Deviation 20.597	-9.42 percent change Standard Deviation 12.159
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 Day 43	-42.94 percent change Standard Deviation 17.217	-8.62 percent change Standard Deviation 14.204	-10.12 percent change Standard Deviation 25.814	-3.61 percent change Standard Deviation 13.949
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 Day 57	-10.00 percent change Standard Deviation 12.039	-0.77 percent change Standard Deviation 10.237	-4.63 percent change Standard Deviation 10.493	4.51 percent change Standard Deviation 17.233
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 Day 71	-9.93 percent change Standard Deviation 10.904	-4.10 percent change Standard Deviation 11.984	-6.95 percent change Standard Deviation 10.454	-8.87 percent change Standard Deviation 11.161
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 Day 85	-3.67 percent change Standard Deviation 14.381	-2.21 percent change Standard Deviation 15.821	-3.47 percent change Standard Deviation 18.833	-10.76 percent change Standard Deviation 13.458
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 Day 2	-5.93 percent change Standard Deviation 13.438	-7.89 percent change Standard Deviation 11.329	-7.05 percent change Standard Deviation 8.311	-8.05 percent change Standard Deviation 10.310
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 Day 3	-9.85 percent change Standard Deviation 7.085	-16.31 percent change Standard Deviation 8.049	-13.06 percent change Standard Deviation 9.137	-14.27 percent change Standard Deviation 11.100
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 Day 4	-17.87 percent change Standard Deviation 8.076	-25.44 percent change Standard Deviation 9.346	-21.20 percent change Standard Deviation 12.194	-19.40 percent change Standard Deviation 11.037
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 Day 6	-21.59 percent change Standard Deviation 17.003	-42.14 percent change Standard Deviation 12.827	-36.62 percent change Standard Deviation 14.459	-29.14 percent change Standard Deviation 13.507
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 Day 8	-40.81 percent change Standard Deviation 13.225	-43.18 percent change Standard Deviation 17.765	-41.47 percent change Standard Deviation 16.099	-34.00 percent change Standard Deviation 9.161
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 Day 15	-58.13 percent change Standard Deviation 12.698	-56.25 percent change Standard Deviation 13.925	-56.45 percent change Standard Deviation 18.729	-53.43 percent change Standard Deviation 14.985
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 Day 22	-63.97 percent change Standard Deviation 7.455	-48.49 percent change Standard Deviation 19.518	-54.63 percent change Standard Deviation 15.528	-34.63 percent change Standard Deviation 15.892
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 Day 29	-60.61 percent change Standard Deviation 5.751	-19.57 percent change Standard Deviation 23.437	-27.49 percent change Standard Deviation 16.364	-8.06 percent change Standard Deviation 14.174
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 Day 50	-28.72 percent change Standard Deviation 14.755	-5.91 percent change Standard Deviation 17.374	-4.41 percent change Standard Deviation 15.372	-2.38 percent change Standard Deviation 15.363
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 Day 64	-7.59 percent change Standard Deviation 15.843	-1.17 percent change Standard Deviation 9.787	-6.94 percent change Standard Deviation 11.837	-1.90 percent change Standard Deviation 19.561

SECONDARY outcome

Timeframe: Day 1 up to Day 85

Population: 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.

Outcome measures

Outcome measures
Measure	PF-04950615 IV 200 mg n=12 Participants Participants received single intravenous (IV) infusion dose of PF-04950615 200 milligram (mg) on Day 1. Participants were followed up to Day 85.	PF-04950615 SC 200 mg (2 Injections of 1 mL) n=13 Participants 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.	PF-04950615 SC 200 mg (1 Injection of 2 mL) n=13 Participants 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.	PF-04950615 SC 100 mg (1 Injection of 1 mL) n=11 Participants 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.
Duration of Fasting LDL-C Suppressed Below 70 mg/dL and 100 mg/dL Below 70 mg/dL	9.4 days Standard Deviation 8.25	8.7 days Standard Deviation 7.55	7.5 days Standard Deviation 7.62	4.5 days Standard Deviation 4.04
Duration of Fasting LDL-C Suppressed Below 70 mg/dL and 100 mg/dL Below 100 mg/dL	21.8 days Standard Deviation 12.64	12.3 days Standard Deviation 10.43	12.8 days Standard Deviation 9.83	8.8 days Standard Deviation 8.10

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 up to Day 85

Population: Safety analysis set included all participants who had at least 1 dose of study medication.

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.

Outcome measures

Outcome measures
Measure	PF-04950615 IV 200 mg n=12 Participants Participants received single intravenous (IV) infusion dose of PF-04950615 200 milligram (mg) on Day 1. Participants were followed up to Day 85.	PF-04950615 SC 200 mg (2 Injections of 1 mL) n=13 Participants 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.	PF-04950615 SC 200 mg (1 Injection of 2 mL) n=13 Participants 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.	PF-04950615 SC 100 mg (1 Injection of 1 mL) n=11 Participants 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.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Adverse Events	7 Participants	7 Participants	8 Participants	6 Participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Serious Adverse Events	0 Participants	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 up to Day 85

Population: Safety analysis set included all participants who had at least 1 dose of study medication.

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).

Outcome measures

Outcome measures
Measure	PF-04950615 IV 200 mg n=12 Participants Participants received single intravenous (IV) infusion dose of PF-04950615 200 milligram (mg) on Day 1. Participants were followed up to Day 85.	PF-04950615 SC 200 mg (2 Injections of 1 mL) n=13 Participants 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.	PF-04950615 SC 200 mg (1 Injection of 2 mL) n=13 Participants 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.	PF-04950615 SC 100 mg (1 Injection of 1 mL) n=11 Participants 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.
Number of Adverse Events (AEs) by Severity Severe	0 adverse events	0 adverse events	0 adverse events	0 adverse events
Number of Adverse Events (AEs) by Severity Mild	12 adverse events	14 adverse events	13 adverse events	5 adverse events
Number of Adverse Events (AEs) by Severity Moderate	0 adverse events	2 adverse events	6 adverse events	2 adverse events

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 up to Day 85

Population: Safety analysis set included all participants who had at least 1 dose of study medication.

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.

Outcome measures

Outcome measures
Measure	PF-04950615 IV 200 mg n=12 Participants Participants received single intravenous (IV) infusion dose of PF-04950615 200 milligram (mg) on Day 1. Participants were followed up to Day 85.	PF-04950615 SC 200 mg (2 Injections of 1 mL) n=13 Participants 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.	PF-04950615 SC 200 mg (1 Injection of 2 mL) n=13 Participants 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.	PF-04950615 SC 100 mg (1 Injection of 1 mL) n=11 Participants 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.
Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Adverse Events	3 Participants	3 Participants	1 Participants	1 Participants
Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Serious Adverse Events	0 Participants	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 up to Day 3

Population: 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.

The injection site reaction included erythema, induration, ecchymosis, injection site pain, injection site pruritus.

Outcome measures

Outcome measures
Measure	PF-04950615 IV 200 mg n=13 Participants Participants received single intravenous (IV) infusion dose of PF-04950615 200 milligram (mg) on Day 1. Participants were followed up to Day 85.	PF-04950615 SC 200 mg (2 Injections of 1 mL) n=13 Participants 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.	PF-04950615 SC 200 mg (1 Injection of 2 mL) n=11 Participants 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.	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.
Number of Participants With Injection Site Reactions	2 Participants	5 Participants	4 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 up to Day 3

Population: 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.

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.

Outcome measures

Outcome measures
Measure	PF-04950615 IV 200 mg n=13 Participants Participants received single intravenous (IV) infusion dose of PF-04950615 200 milligram (mg) on Day 1. Participants were followed up to Day 85.	PF-04950615 SC 200 mg (2 Injections of 1 mL) n=13 Participants 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.	PF-04950615 SC 200 mg (1 Injection of 2 mL) n=11 Participants 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.	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.
Number of Injection Site Reactions Reported as Adverse Events	0 injection site reactions	0 injection site reactions	0 injection site reactions	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1: Immediately post-dose, 0.5, 1.0, 2.0, 8.0 hours post-dose; Day 2, 3

Population: 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.

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.

Outcome measures

Outcome measures
Measure	PF-04950615 IV 200 mg n=13 Participants Participants received single intravenous (IV) infusion dose of PF-04950615 200 milligram (mg) on Day 1. Participants were followed up to Day 85.	PF-04950615 SC 200 mg (2 Injections of 1 mL) n=13 Participants 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.	PF-04950615 SC 200 mg (1 Injection of 2 mL) n=13 Participants 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.	PF-04950615 SC 100 mg (1 Injection of 1 mL) n=11 Participants 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.
Visual Analogue Scale (VAS) Day 1: Immediately post-dose	3.678 units on a scale Standard Deviation 4.8618	2.308 units on a scale Standard Deviation 2.3232	3.824 units on a scale Standard Deviation 7.7523	3.273 units on a scale Standard Deviation 3.3194
Visual Analogue Scale (VAS) Day 1: 0.5 hour	1.462 units on a scale Standard Deviation 1.4500	1.769 units on a scale Standard Deviation 1.8328	3.208 units on a scale Standard Deviation 7.0388	1.455 units on a scale Standard Deviation 2.2962
Visual Analogue Scale (VAS) Day 1: 1.0 hour	1.231 units on a scale Standard Deviation 1.3009	1.462 units on a scale Standard Deviation 1.4500	1.228 units on a scale Standard Deviation 1.8771	1.364 units on a scale Standard Deviation 1.4334
Visual Analogue Scale (VAS) Day 1: 2.0 hours	1.651 units on a scale Standard Deviation 1.5021	1.462 units on a scale Standard Deviation 1.5064	1.305 units on a scale Standard Deviation 1.8874	1.455 units on a scale Standard Deviation 2.0181
Visual Analogue Scale (VAS) Day 1: 8.0 hours	1.231 units on a scale Standard Deviation 1.4806	1.308 units on a scale Standard Deviation 1.3775	1.077 units on a scale Standard Deviation 1.7541	1.182 units on a scale Standard Deviation 1.5374
Visual Analogue Scale (VAS) Day 2	1.077 units on a scale Standard Deviation 1.3205	1.461 units on a scale Standard Deviation 1.5610	1.230 units on a scale Standard Deviation 2.1663	1.364 units on a scale Standard Deviation 1.5015
Visual Analogue Scale (VAS) Day 3	—	0.990 units on a scale Standard Deviation NA Standard deviation was not calculated as only 1 participant was evaluable.	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 up to Day 85

Population: Safety analysis set included all participants who had at least 1 dose of study medication.

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.

Outcome measures

Outcome measures
Measure	PF-04950615 IV 200 mg n=12 Participants Participants received single intravenous (IV) infusion dose of PF-04950615 200 milligram (mg) on Day 1. Participants were followed up to Day 85.	PF-04950615 SC 200 mg (2 Injections of 1 mL) n=13 Participants 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.	PF-04950615 SC 200 mg (1 Injection of 2 mL) n=13 Participants 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.	PF-04950615 SC 100 mg (1 Injection of 1 mL) n=11 Participants 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.
Number of Participants With Clinically Significant Laboratory Abnormalities	0 Participants	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 up to Day 85

Population: Safety analysis set included all participants who had at least 1 dose of study medication.

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.

Outcome measures

Outcome measures
Measure	PF-04950615 IV 200 mg n=12 Participants Participants received single intravenous (IV) infusion dose of PF-04950615 200 milligram (mg) on Day 1. Participants were followed up to Day 85.	PF-04950615 SC 200 mg (2 Injections of 1 mL) n=13 Participants 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.	PF-04950615 SC 200 mg (1 Injection of 2 mL) n=13 Participants 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.	PF-04950615 SC 100 mg (1 Injection of 1 mL) n=11 Participants 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.
Number of Participants With Clinically Significant Changes in Vital Signs	1 Participants	1 Participants	4 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 up to Day 85

Population: Safety analysis set included all participants who had at least 1 dose of study medication.

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.

Outcome measures

Outcome measures
Measure	PF-04950615 IV 200 mg n=12 Participants Participants received single intravenous (IV) infusion dose of PF-04950615 200 milligram (mg) on Day 1. Participants were followed up to Day 85.	PF-04950615 SC 200 mg (2 Injections of 1 mL) n=13 Participants 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.	PF-04950615 SC 200 mg (1 Injection of 2 mL) n=13 Participants 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.	PF-04950615 SC 100 mg (1 Injection of 1 mL) n=11 Participants 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.
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)	0 Participants	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 up to Day 85

Population: Safety analysis set included all participants who had at least 1 dose of study medication.

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).

Outcome measures

Outcome measures
Measure	PF-04950615 IV 200 mg n=12 Participants Participants received single intravenous (IV) infusion dose of PF-04950615 200 milligram (mg) on Day 1. Participants were followed up to Day 85.	PF-04950615 SC 200 mg (2 Injections of 1 mL) n=13 Participants 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.	PF-04950615 SC 200 mg (1 Injection of 2 mL) n=13 Participants 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.	PF-04950615 SC 100 mg (1 Injection of 1 mL) n=11 Participants 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.
Percentage of Participants With Positive Anti-drug (Anti-PF 04950615) Antibodies	8.3 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants

Adverse Events

PF-04950615 IV 200 mg

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

PF-04950615 SC 200 mg (2 Injections of 1 mL)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

PF-04950615 SC 200 mg (1 Injection of 2 mL)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

PF-04950615 SC 100 mg (1 Injection of 1 mL)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	PF-04950615 IV 200 mg n=12 participants at risk Participants received single intravenous (IV) infusion dose of PF-04950615 200 milligram (mg) on Day 1. Participants were followed up to Day 85.	PF-04950615 SC 200 mg (2 Injections of 1 mL) n=13 participants at risk 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.	PF-04950615 SC 200 mg (1 Injection of 2 mL) n=13 participants at risk 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.	PF-04950615 SC 100 mg (1 Injection of 1 mL) n=11 participants at risk 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.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain	0.00% 0/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Diarrhoea	0.00% 0/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gingival bleeding	0.00% 0/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Crying	0.00% 0/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Conjunctivitis bacterial	0.00% 0/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Gastroenteritis	0.00% 0/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	15.4% 2/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Upper respiratory tract infection	25.0% 3/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	15.4% 2/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	23.1% 3/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	36.4% 4/11 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Viral infection	16.7% 2/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Fall	0.00% 0/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Joint injury	0.00% 0/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Skeletal injury	0.00% 0/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Myalgia	16.7% 2/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Pain in extremity	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Headache	16.7% 2/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	23.1% 3/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	23.1% 3/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	9.1% 1/11 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Affect lability	0.00% 0/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Libido increased	0.00% 0/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Asthma	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Nasal congestion	8.3% 1/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Papule	0.00% 0/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/11 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

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Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER