Trial Outcomes & Findings for Efficacy, Safety And Tolerability Study Of RN6G In Subjects With Geographic Atrophy Secondary to Age-related Macular Degeneration (NCT NCT01577381)

NCT ID: NCT01577381

Last Updated: 2016-03-16

Results Overview

GA is the advanced form of dry age-related macular degeneration (AMD). The reduction in GA area of the study eye was based on Fundus Autofluorescence (FAF) at 30 days post last dose administration (Day 309).

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 10 participants
• Primary outcome timeframe: Baseline and Day 309
• Results posted on: 2016-03-16

Participant Flow

Participant milestones

Measure	PF-04382923 2.5 mg/kg PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.	PF-04382923 7.5 mg/kg PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.	PF-04382923 15.0 mg/kg PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.	Placebo Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
Overall Study STARTED	2	3	3	2
Overall Study COMPLETED	0	0	0	0
Overall Study NOT COMPLETED	2	3	3	2

Reasons for withdrawal

Measure	PF-04382923 2.5 mg/kg PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.	PF-04382923 7.5 mg/kg PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.	PF-04382923 15.0 mg/kg PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.	Placebo Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
Overall Study Discontinued	2	1	2	2
Overall Study Ongoing at Date of Cut-Off	0	2	1	0

Baseline Characteristics

Efficacy, Safety And Tolerability Study Of RN6G In Subjects With Geographic Atrophy Secondary to Age-related Macular Degeneration

Baseline characteristics by cohort

Measure	PF-04382923 7.5 mg/kg n=3 Participants PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.	PF-04382923 2.5 mg/kg n=2 Participants PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.	PF-04382923 15.0 mg/kg n=3 Participants PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.	Placebo n=2 Participants Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.	Total n=10 Participants Total of all reporting groups
Age, Continuous	71.0 years STANDARD_DEVIATION 6.2 • n=7 Participants	82.5 years STANDARD_DEVIATION 0.7 • n=5 Participants	74.0 years STANDARD_DEVIATION 12.2 • n=5 Participants	73.0 years STANDARD_DEVIATION 11.3 • n=4 Participants	74.6 years STANDARD_DEVIATION 8.6 • n=21 Participants
Sex: Female, Male Female	3 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	7 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline and Day 309

Population: Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug \[1 was not dosed and there was notable variability on how many doses were received by the other 7\]; 2 were assigned to placebo).

GA is the advanced form of dry age-related macular degeneration (AMD). The reduction in GA area of the study eye was based on Fundus Autofluorescence (FAF) at 30 days post last dose administration (Day 309).

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline and Day 449

Population: Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug \[1 was not dosed and there was notable variability on how many doses were received by the other 7\]; 2 were assigned to placebo).

GA is the advanced form of dry AMD. The reduction in GA area in the study eye was based on FAF at end of study (Day 449).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Month 9, Month 12, Month 15, and End of Study

Population: Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug \[1 was not dosed and there was notable variability on how many doses were received by the other 7\]; 2 were assigned to placebo).

BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Month 9, Month 12, Month 15, and End of Study

Population: Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug \[1 was not dosed and there was notable variability on how many doses were received by the other 7\]; 2 were assigned to placebo).

BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Month 9, Month 12, Month 15, and End of Study

Population: Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug \[1 was not dosed and there was notable variability on how many doses were received by the other 7\]; 2 were assigned to placebo).

BCVA is measured using an eye chart and is reported as the number of lines read correctly in the study eye. The lower the number of lines read correctly on the eye chart, the worse the vision (or visual acuity).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Month 9, Month 12, Month 15, and End of Study

Population: Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug \[1 was not dosed and there was notable variability on how many doses were received by the other 7\]; 2 were assigned to placebo).

LL-BCVA is the measure of visual acuity under low light conditions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Month 9, Month 12, Month 15, and End of Study

Population: Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug \[1 was not dosed and there was notable variability on how many doses were received by the other 7\]; 2 were assigned to placebo).

LL-BCVA is the measure of visual acuity under low light conditions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Month 9, Month 12, Month 15, and End of Study

Population: Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug \[1 was not dosed and there was notable variability on how many doses were received by the other 7\]; 2 were assigned to placebo).

LL-BCVA is the measure of visual acuity under low light conditions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Month 9, Month 12, Month 15, and End of Study

Population: Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug \[1 was not dosed and there was notable variability on how many doses were received by the other 7\]; 2 were assigned to placebo).

Contrast sensitivity was measured using the Pelli-Robson chart at 1 meter. Participants were tested for contrast sensitivity using +0.50 addition over the protocol refraction providing the best-corrected distance VA. Contrast sensitivity was recorded as the log of the faintest triplet for which 2 of the 3 letters were read correctly.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Month 9, Month 12, Month 15, and End of Study

Population: Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug \[1 was not dosed and there was notable variability on how many doses were received by the other 7\]; 2 were assigned to placebo).

Contrast sensitivity was measured using the Pelli-Robson chart at 1 meter. Subjects were tested for contrast sensitivity using +0.50 addition over the protocol refraction providing the best-corrected distance VA. Contrast sensitivity was recorded as the log of the faintest triplet for which 2 of the 3 letters were read correctly.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Month 9, Month 12, Month 15, and End of Study

Population: Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug \[1 was not dosed and there was notable variability on how many doses were received by the other 7\]; 2 were assigned to placebo).

Reading speed in the study eye was assessed using modified Bailey-Lovie word charts. Participants read the chart for 2 minutes and the number of words read correctly per minute was totaled. An increase in the number of words read correctly indicated an improvement and a decrease in the number of words read correctly indicated a worsening.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Month 9, Month 12, Month 15, and End of Study

Population: Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug \[1 was not dosed and there was notable variability on how many doses were received by the other 7\]; 2 were assigned to placebo).

Reading speed in the study eye was assessed using modified Bailey-Lovie word charts. Participants read the chart for 2 minutes and the number of words read correctly per minute was totaled. An increase in the number of words read correctly indicated an improvement and a decrease in the number of words read correctly indicated a worsening.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Month 9, Month 12, Month 15, and End of Study

Population: Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug \[1 was not dosed and there was notable variability on how many doses were received by the other 7\]; 2 were assigned to placebo).

Reading speed in the study eye was assessed using modified Bailey-Lovie word charts. Participants read the chart for 2 minutes and the number of words read correctly per minute was totaled. An increase in the number of words read correctly indicated an improvement and a decrease in the number of words read correctly indicated a worsening.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Month 9, Month 12, Month 15, and End of Study

Population: Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug \[1 was not dosed and there was notable variability on how many doses were received by the other 7\]; 2 were assigned to placebo).

Reading Acuity was measured using the Radner reading charts and expressed in terms of logRAD (logrithmic Reading Acuity Determination).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Month 9, Month 12, Month 15, and End of Study

Population: Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug \[1 was not dosed and there was notable variability on how many doses were received by the other 7\]; 2 were assigned to placebo).

Reading Acuity was measured using the Radner reading charts and expressed in terms of logRAD.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Month 9, Month 12, Month 15, and End of Study

Population: Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug \[1 was not dosed and there was notable variability on how many doses were received by the other 7\]; 2 were assigned to placebo).

Reading Acuity was measured using the Radner reading charts and expressed in terms of logRAD.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Month 9, Month 12, Month 15, and End of Study

Population: Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug \[1 was not dosed and there was notable variability on how many doses were received by the other 7\]; 2 were assigned to placebo).

The critical print size is the smallest print size at which participants can read with their maximum reading speed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Month 9, Month 12, Month 15, and End of Study

Population: Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug \[1 was not dosed and there was notable variability on how many doses were received by the other 7\]; 2 were assigned to placebo).

The critical print size is the smallest print size at which participants can read with their maximum reading speed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 85 and Day 169

Population: Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug \[1 was not dosed and there was notable variability on how many doses were received by the other 7\]; 2 were assigned to placebo).

Laboratory assessments include: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid albumin, total protein); coagulation assessments.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Screening, Days 28, 57, 85, 113, 141, and 169

Population: Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug \[1 was not dosed and there was notable variability on how many doses were received by the other 7\]; 2 were assigned to placebo).

Vital sign assessments include: supine systolic and diastolic blood pressure, pulse rate and body temperature.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Days 28, 57, 85, 113 and 169

Population: Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug \[1 was not dosed and there was notable variability on how many doses were received by the other 7\]; 2 were assigned to placebo).

Clinically significant ECG findings include: corrected QT (QTc) > 450 msec, QTc >500 msec, change in QTc between 30 and 60 msec, change in QTc greater than or equal to 60 msec.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 57 and Day 169

Population: Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug \[1 was not dosed and there was notable variability on how many doses were received by the other 7\]; 2 were assigned to placebo).

The number of participants with positive ADA was to be summarized for each treatment arm.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Days 28, 57, 85, 113, 141 and 169

Population: The safety analysis set included all participants who received at least 1 dose of study drug.

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Seriousness of an AE was assessed under the criteria of serious adverse event (SAE). 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.

Outcome measures

Measure	PF-04382923 2.5 mg/kg n=2 Participants PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.	PF-04382923 7.5 mg/kg n=3 Participants PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.	PF-04382923 15.0 mg/kg n=3 Participants PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.	Placebo n=2 Participants Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) According to Seriousness AE	2 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) According to Seriousness SAE	1 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Days 28, 57, 85, 113, 141 and 169

Population: The safety analysis set included all participants who received at least one dose of study product.

An AE was an untoward medical occurrence in a participant who received study drug without regard to causal relationship. An investigator's relationship assessment is the determination of whether there exists a reasonable possibility that the investigational product caused or contributed to an AE.

Outcome measures

Measure	PF-04382923 2.5 mg/kg n=2 Participants PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.	PF-04382923 7.5 mg/kg n=3 Participants PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.	PF-04382923 15.0 mg/kg n=3 Participants PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.	Placebo n=2 Participants Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
Number of Participants With Treatment-Related TEAEs	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449

Population: Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug \[1 was not dosed and there was notable variability on how many doses were received by the other 7\]; 2 were assigned to placebo).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449

Population: Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug \[1 was not dosed and there was notable variability on how many doses were received by the other 7\]; 2 were assigned to placebo).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449

Population: Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug \[1 was not dosed and there was notable variability on how many doses were received by the other 7\]; 2 were assigned to placebo).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449

Population: Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug \[1 was not dosed and there was notable variability on how many doses were received by the other 7\]; 2 were assigned to placebo).

Steady state total body clearance equals infusion rate (zero order) divided by steady state plasma concentration of study drug (R0/Css)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449

Population: Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug \[1 was not dosed and there was notable variability on how many doses were received by the other 7\]; 2 were assigned to placebo).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Days 1, 28, 57, 85, 169, 253, 281, 309, 337 and 449

Population: Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug \[1 was not dosed and there was notable variability on how many doses were received by the other 7\]; 2 were assigned to placebo).

Population PK parameters were to be evaluated for Cmax, AUCt, Cmin, CLss, and Rac for AUCt between the first and last (11th) doses.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Day 449

Population: Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug \[1 was not dosed and there was notable variability on how many doses were received by the other 7\]; 2 were assigned to placebo).

Concentration of total amino acid peptide, known as A-Beta 1-x, in plasma.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Day 449

Population: Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug \[1 was not dosed and there was notable variability on how many doses were received by the other 7\]; 2 were assigned to placebo).

Concentration of amino acid peptide, known as A-Beta 1-40, in plasma.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Day 449

Population: Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug \[1 was not dosed and there was notable variability on how many doses were received by the other 7\]; 2 were assigned to placebo).

Concentration of amino acid peptide, known as A-Beta 1-42, in plasma.

Outcome measures

Outcome data not reported

Adverse Events

PF-04382923 2.5 mg/kg

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

PF-04382923 7.5 mg/kg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PF-04382923 15.0 mg/kg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	PF-04382923 2.5 mg/kg n=2 participants at risk PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.	PF-04382923 7.5 mg/kg n=3 participants at risk PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.	PF-04382923 15.0 mg/kg n=3 participants at risk PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.	Placebo n=2 participants at risk Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
Nervous system disorders Carotid artery stenosis	50.0% 1/2 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 subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.	0.00% 0/3 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 subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.	0.00% 0/3 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 subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.	0.00% 0/2 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 subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.

Other adverse events

Measure	PF-04382923 2.5 mg/kg n=2 participants at risk PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.	PF-04382923 7.5 mg/kg n=3 participants at risk PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.	PF-04382923 15.0 mg/kg n=3 participants at risk PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.	Placebo n=2 participants at risk Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
Gastrointestinal disorders Irritable bowel syndrome	0.00% 0/2 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 subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.	0.00% 0/3 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 subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.	33.3% 1/3 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 subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.	0.00% 0/2 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 subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Influenza	50.0% 1/2 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 subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.	0.00% 0/3 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 subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.	0.00% 0/3 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 subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.	0.00% 0/2 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 subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Upper respiratory tract infection	50.0% 1/2 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 subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.	0.00% 0/3 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 subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.	0.00% 0/3 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 subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.	0.00% 0/2 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 subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Infections and infestations Urinary tract infection	0.00% 0/2 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 subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.	0.00% 0/3 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 subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.	33.3% 1/3 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 subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.	0.00% 0/2 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 subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/2 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 subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.	0.00% 0/3 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 subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.	0.00% 0/3 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 subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.	50.0% 1/2 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 subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Nervous system disorders Headache	50.0% 1/2 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 subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.	0.00% 0/3 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 subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.	33.3% 1/3 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 subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.	0.00% 0/2 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 subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Renal and urinary disorders Nephropathy	0.00% 0/2 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 subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.	0.00% 0/3 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 subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.	33.3% 1/3 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 subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.	0.00% 0/2 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 subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	50.0% 1/2 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 subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.	0.00% 0/3 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 subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.	0.00% 0/3 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 subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.	0.00% 0/2 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 subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee Restriction Description: 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