Trial Outcomes & Findings for Investigation of Safety, Tolerability, Immunogenicity and Pharmacokinetics of Single-Dose of PF-06823859 in Japanese Healthy Participants (NCT NCT05037409)
NCT ID: NCT05037409
Last Updated: 2023-12-15
Results Overview
Adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was any untoward medical occurrence that at any dose resulted in any of following outcomes/deemed significant for any other reason: death; initial /prolonged inpatient hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly/birth defect and suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. TEAEs were the events between first dose of study drug and up to Day 157, that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious (if occurred) and all non-serious adverse events.
COMPLETED
PHASE1
13 participants
Day 1 up to maximum of Day 157
2023-12-15
Participant Flow
A total of 13 participants were enrolled and randomized in the study.
Participant milestones
| Measure |
Cohort 1: PF-06823859 300 mg
Participants were randomized and administered a single dose of PF-06823859 300 milligrams (mg) as 60 minute intravenous (IV) infusion using a calibrated infusion pump on Day 1 of Cohort 1. Participants were followed up to Day 157.
|
Cohort 2: PF-06823859 900 mg
Participants were randomized and administered a single dose of PF-06823859 900 mg as 60 minute IV infusion using a calibrated infusion pump on Day 1 of Cohort 2. Participants were followed up to Day 157.
|
Placebo
Participants who were randomized and administered placebo as 60 minute IV infusion using a calibrated infusion pump on Day 1 of each Cohort 1 and Cohort 2 respectively were included in this reporting arm. Participants were followed up to Day 157 (relative to Day 1 of each Cohort).
|
|---|---|---|---|
|
Blinded Treatment (1 Day)
STARTED
|
5
|
6
|
2
|
|
Blinded Treatment (1 Day)
Treated
|
5
|
5
|
2
|
|
Blinded Treatment (1 Day)
COMPLETED
|
5
|
5
|
2
|
|
Blinded Treatment (1 Day)
NOT COMPLETED
|
0
|
1
|
0
|
|
Follow-up ( Up to Day 157)
STARTED
|
5
|
5
|
2
|
|
Follow-up ( Up to Day 157)
COMPLETED
|
5
|
5
|
2
|
|
Follow-up ( Up to Day 157)
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1: PF-06823859 300 mg
Participants were randomized and administered a single dose of PF-06823859 300 milligrams (mg) as 60 minute intravenous (IV) infusion using a calibrated infusion pump on Day 1 of Cohort 1. Participants were followed up to Day 157.
|
Cohort 2: PF-06823859 900 mg
Participants were randomized and administered a single dose of PF-06823859 900 mg as 60 minute IV infusion using a calibrated infusion pump on Day 1 of Cohort 2. Participants were followed up to Day 157.
|
Placebo
Participants who were randomized and administered placebo as 60 minute IV infusion using a calibrated infusion pump on Day 1 of each Cohort 1 and Cohort 2 respectively were included in this reporting arm. Participants were followed up to Day 157 (relative to Day 1 of each Cohort).
|
|---|---|---|---|
|
Blinded Treatment (1 Day)
Failure to comply with site instruction
|
0
|
1
|
0
|
Baseline Characteristics
Investigation of Safety, Tolerability, Immunogenicity and Pharmacokinetics of Single-Dose of PF-06823859 in Japanese Healthy Participants
Baseline characteristics by cohort
| Measure |
Cohort 1: PF-06823859 300 mg
n=5 Participants
Participants were randomized and administered a single dose of PF-06823859 300 mg as 60 minute IV infusion using a calibrated infusion pump on Day 1 of Cohort 1. Participants were followed up to Day 157.
|
Cohort 2: PF-06823859 900 mg
n=5 Participants
Participants were randomized and administered a single dose of PF-06823859 900 mg as 60 minute IV infusion using a calibrated infusion pump on Day 1 of Cohort 2. Participants were followed up to Day 157.
|
Placebo
n=2 Participants
Participants who were randomized and administered placebo as 60 minute IV infusion using a calibrated infusion pump on Day 1 of each Cohort 1 and Cohort 2 respectively were included in this reporting arm. Participants were followed up to Day 157 (relative to Day 1 of each Cohort).
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
38.80 Years
STANDARD_DEVIATION 14.24 • n=5 Participants
|
33.80 Years
STANDARD_DEVIATION 13.95 • n=7 Participants
|
35.50 Years
STANDARD_DEVIATION 13.44 • n=5 Participants
|
36.17 Years
STANDARD_DEVIATION 12.91 • n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to maximum of Day 157Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was any untoward medical occurrence that at any dose resulted in any of following outcomes/deemed significant for any other reason: death; initial /prolonged inpatient hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly/birth defect and suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. TEAEs were the events between first dose of study drug and up to Day 157, that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious (if occurred) and all non-serious adverse events.
Outcome measures
| Measure |
Cohort 1: PF-06823859 300 mg
n=5 Participants
Participants were randomized and administered a single dose of PF-06823859 300 mg as 60 minute IV infusion using a calibrated infusion pump on Day 1 of Cohort 1. Participants were followed up to Day 157.
|
Cohort 2: PF-06823859 900 mg
n=5 Participants
Participants were randomized and administered a single dose of PF-06823859 900 mg as 60 minute IV infusion using a calibrated infusion pump on Day 1 of Cohort 2. Participants were followed up to Day 157.
|
Placebo
n=2 Participants
Participants who were randomized and administered placebo as 60 minute IV infusion using a calibrated infusion pump on Day 1 of each Cohort 1 and Cohort 2 respectively were included in this reporting arm. Participants were followed up to Day 157 (relative to Day 1 of each Cohort).
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
TEAEs
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to maximum of Day 157Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
IRR included AEs potentially related to infusion related reaction and was determined by blind medical review prior to the database release.
Outcome measures
| Measure |
Cohort 1: PF-06823859 300 mg
n=5 Participants
Participants were randomized and administered a single dose of PF-06823859 300 mg as 60 minute IV infusion using a calibrated infusion pump on Day 1 of Cohort 1. Participants were followed up to Day 157.
|
Cohort 2: PF-06823859 900 mg
n=5 Participants
Participants were randomized and administered a single dose of PF-06823859 900 mg as 60 minute IV infusion using a calibrated infusion pump on Day 1 of Cohort 2. Participants were followed up to Day 157.
|
Placebo
n=2 Participants
Participants who were randomized and administered placebo as 60 minute IV infusion using a calibrated infusion pump on Day 1 of each Cohort 1 and Cohort 2 respectively were included in this reporting arm. Participants were followed up to Day 157 (relative to Day 1 of each Cohort).
|
|---|---|---|---|
|
Number of Participants With Infusion Related Reaction (IRR)
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From start of study intervention infusion up to 60 minutes on Day 1Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Participants were monitored from start of study intervention infusion until the end of infusion to assess the infusion sites for erythema, induration, ecchymosis, pain, and pruritus, or other observed characteristics after study intervention.
Outcome measures
| Measure |
Cohort 1: PF-06823859 300 mg
n=5 Participants
Participants were randomized and administered a single dose of PF-06823859 300 mg as 60 minute IV infusion using a calibrated infusion pump on Day 1 of Cohort 1. Participants were followed up to Day 157.
|
Cohort 2: PF-06823859 900 mg
n=5 Participants
Participants were randomized and administered a single dose of PF-06823859 900 mg as 60 minute IV infusion using a calibrated infusion pump on Day 1 of Cohort 2. Participants were followed up to Day 157.
|
Placebo
n=2 Participants
Participants who were randomized and administered placebo as 60 minute IV infusion using a calibrated infusion pump on Day 1 of each Cohort 1 and Cohort 2 respectively were included in this reporting arm. Participants were followed up to Day 157 (relative to Day 1 of each Cohort).
|
|---|---|---|---|
|
Number of Participants With Infusion Site Reaction
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to maximum of Day 157Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Outcome measures
| Measure |
Cohort 1: PF-06823859 300 mg
n=5 Participants
Participants were randomized and administered a single dose of PF-06823859 300 mg as 60 minute IV infusion using a calibrated infusion pump on Day 1 of Cohort 1. Participants were followed up to Day 157.
|
Cohort 2: PF-06823859 900 mg
n=5 Participants
Participants were randomized and administered a single dose of PF-06823859 900 mg as 60 minute IV infusion using a calibrated infusion pump on Day 1 of Cohort 2. Participants were followed up to Day 157.
|
Placebo
n=2 Participants
Participants who were randomized and administered placebo as 60 minute IV infusion using a calibrated infusion pump on Day 1 of each Cohort 1 and Cohort 2 respectively were included in this reporting arm. Participants were followed up to Day 157 (relative to Day 1 of each Cohort).
|
|---|---|---|---|
|
Number of Participants With Viral Infection
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to maximum of Day 157Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Laboratory test abnormalities included hematology: basophils/leukocytes greater than (\>)1.2\* upper limit of normal (ULN), eosinophils/leukocytes \>1.2\* ULN, monocytes/leukocytes \>1.2\* ULN; clinical chemistry: bilirubin \> 1.5\* ULN, aspartate aminotransferase \>3.0\* ULN, urate \>1.2\* ULN; urinalysis: ketones greater than or equal to (\>=)1, urine hemoglobin \>=1.
Outcome measures
| Measure |
Cohort 1: PF-06823859 300 mg
n=5 Participants
Participants were randomized and administered a single dose of PF-06823859 300 mg as 60 minute IV infusion using a calibrated infusion pump on Day 1 of Cohort 1. Participants were followed up to Day 157.
|
Cohort 2: PF-06823859 900 mg
n=5 Participants
Participants were randomized and administered a single dose of PF-06823859 900 mg as 60 minute IV infusion using a calibrated infusion pump on Day 1 of Cohort 2. Participants were followed up to Day 157.
|
Placebo
n=2 Participants
Participants who were randomized and administered placebo as 60 minute IV infusion using a calibrated infusion pump on Day 1 of each Cohort 1 and Cohort 2 respectively were included in this reporting arm. Participants were followed up to Day 157 (relative to Day 1 of each Cohort).
|
|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities
|
2 Participants
|
4 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From baseline (pre-dose measurement at Day 1) up to Day 157Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Vital sign abnormalities were categorized as: a) supine systolic blood pressure: minimum: less than (\<) 90 millimeter of mercury (mmHg), maximum decrease from baseline: greater than or equal to (\>=) 30 mmHg, maximum increase from baseline: \>=30 mmHg; b) supine diastolic blood pressure: minimum: \<50 mmHg, maximum decrease from baseline: \>=20 mmHg, maximum increase from baseline: \>=20 mmHg; c) supine pulse rate: minimum \<40 beats per minute (bpm), maximum \>120 bpm. Number of participants with any vital sign abnormality were reported in this outcome measure.
Outcome measures
| Measure |
Cohort 1: PF-06823859 300 mg
n=5 Participants
Participants were randomized and administered a single dose of PF-06823859 300 mg as 60 minute IV infusion using a calibrated infusion pump on Day 1 of Cohort 1. Participants were followed up to Day 157.
|
Cohort 2: PF-06823859 900 mg
n=5 Participants
Participants were randomized and administered a single dose of PF-06823859 900 mg as 60 minute IV infusion using a calibrated infusion pump on Day 1 of Cohort 2. Participants were followed up to Day 157.
|
Placebo
n=2 Participants
Participants who were randomized and administered placebo as 60 minute IV infusion using a calibrated infusion pump on Day 1 of each Cohort 1 and Cohort 2 respectively were included in this reporting arm. Participants were followed up to Day 157 (relative to Day 1 of each Cohort).
|
|---|---|---|---|
|
Number of Participants With Vital Sign Abnormalities of Pre-defined Criteria
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From baseline (pre-dose measurement at Day 1) up to Day 157Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Criteria for ECG abnormalities: maximum PR interval \>=300 milliseconds (msec); maximum increase in PR interval from baseline \>=25 percent (%) for baseline value of \>200 msec; maximum increase in PR interval from baseline \>=50% for baseline value of less than or equal to (\<=) 200 msec; maximum QRS interval \>=140 msec and maximum increase from baseline \>=50%; QT interval of \>=500 msec; QTcF interval (Fridericia's Correction of QTc interval) mild: \>=450 msec to \<480 msec, moderate: \>=480 msec to \<500 msec; increase from baseline \>=30 msec to \<60 msec and severe: \>=500 msec; increase from baseline \>=60 msec.
Outcome measures
| Measure |
Cohort 1: PF-06823859 300 mg
n=5 Participants
Participants were randomized and administered a single dose of PF-06823859 300 mg as 60 minute IV infusion using a calibrated infusion pump on Day 1 of Cohort 1. Participants were followed up to Day 157.
|
Cohort 2: PF-06823859 900 mg
n=5 Participants
Participants were randomized and administered a single dose of PF-06823859 900 mg as 60 minute IV infusion using a calibrated infusion pump on Day 1 of Cohort 2. Participants were followed up to Day 157.
|
Placebo
n=2 Participants
Participants who were randomized and administered placebo as 60 minute IV infusion using a calibrated infusion pump on Day 1 of each Cohort 1 and Cohort 2 respectively were included in this reporting arm. Participants were followed up to Day 157 (relative to Day 1 of each Cohort).
|
|---|---|---|---|
|
Number of Participants With Electrocardiogram (ECG) Abnormalities of Pre-defined Criteria
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre dose on Day 1; 1, 2, 6, 12, 24, 48 and 96 hours post-dose on Day 1; Anytime during site visit at Day 15, 29, 43, 57, 71, 99, 127, 157Population: Pharmacokinetic (PK) parameter set included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and who had at least 1 of the PK parameters of PF-06823859 of interest calculated.
Cmax was defined as the maximum observed serum concentration of PF-06823859. Cmax was analyzed and reported consolidated for all the time-points through Day 1 to Day 157.
Outcome measures
| Measure |
Cohort 1: PF-06823859 300 mg
n=5 Participants
Participants were randomized and administered a single dose of PF-06823859 300 mg as 60 minute IV infusion using a calibrated infusion pump on Day 1 of Cohort 1. Participants were followed up to Day 157.
|
Cohort 2: PF-06823859 900 mg
n=5 Participants
Participants were randomized and administered a single dose of PF-06823859 900 mg as 60 minute IV infusion using a calibrated infusion pump on Day 1 of Cohort 2. Participants were followed up to Day 157.
|
Placebo
Participants who were randomized and administered placebo as 60 minute IV infusion using a calibrated infusion pump on Day 1 of each Cohort 1 and Cohort 2 respectively were included in this reporting arm. Participants were followed up to Day 157 (relative to Day 1 of each Cohort).
|
|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) of PF-06823859
|
134.4 Microgram per milliliter
Geometric Coefficient of Variation 16
|
350.1 Microgram per milliliter
Geometric Coefficient of Variation 10
|
—
|
SECONDARY outcome
Timeframe: Pre dose on Day 1; 1, 2, 6, 12, 24, 48 and 96 hours post-dose on Day 1; Anytime during site visit at Day 15, 29, 43, 57, 71, 99, 127, 157Population: PK parameter set included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and who had at least 1 of the PK parameters of PF-06823859 of interest calculated.
Cmax was maximum observed serum concentration. Cmax (dn) was calculated as Cmax/dose. Cmax (dn) was analyzed and reported consolidated for all the time-points through Day 1 to Day 157.
Outcome measures
| Measure |
Cohort 1: PF-06823859 300 mg
n=5 Participants
Participants were randomized and administered a single dose of PF-06823859 300 mg as 60 minute IV infusion using a calibrated infusion pump on Day 1 of Cohort 1. Participants were followed up to Day 157.
|
Cohort 2: PF-06823859 900 mg
n=5 Participants
Participants were randomized and administered a single dose of PF-06823859 900 mg as 60 minute IV infusion using a calibrated infusion pump on Day 1 of Cohort 2. Participants were followed up to Day 157.
|
Placebo
Participants who were randomized and administered placebo as 60 minute IV infusion using a calibrated infusion pump on Day 1 of each Cohort 1 and Cohort 2 respectively were included in this reporting arm. Participants were followed up to Day 157 (relative to Day 1 of each Cohort).
|
|---|---|---|---|
|
Dose Normalized Cmax (Cmax [dn]) of PF-06823859
|
0.4483 Microgram per milliliter per milligram
Geometric Coefficient of Variation 16
|
0.3890 Microgram per milliliter per milligram
Geometric Coefficient of Variation 10
|
—
|
SECONDARY outcome
Timeframe: Pre dose on Day 1; 1, 2, 6, 12, 24, 48 and 96 hours post-dose on Day 1; Anytime during site visit at Day 15, 29, 43, 57, 71, 99, 127, 157Population: PK parameter set included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and who had at least 1 of the PK parameters of PF-06823859 of interest calculated.
Tmax was defined as the time to reach maximum observed serum concentration of PF-06823859 and was observed directly from data. Tmax was analyzed and reported consolidated for all the time-points through Day 1 to Day 157.
Outcome measures
| Measure |
Cohort 1: PF-06823859 300 mg
n=5 Participants
Participants were randomized and administered a single dose of PF-06823859 300 mg as 60 minute IV infusion using a calibrated infusion pump on Day 1 of Cohort 1. Participants were followed up to Day 157.
|
Cohort 2: PF-06823859 900 mg
n=5 Participants
Participants were randomized and administered a single dose of PF-06823859 900 mg as 60 minute IV infusion using a calibrated infusion pump on Day 1 of Cohort 2. Participants were followed up to Day 157.
|
Placebo
Participants who were randomized and administered placebo as 60 minute IV infusion using a calibrated infusion pump on Day 1 of each Cohort 1 and Cohort 2 respectively were included in this reporting arm. Participants were followed up to Day 157 (relative to Day 1 of each Cohort).
|
|---|---|---|---|
|
Time to Reach Maximum Observed Serum Concentration (Tmax) of PF-06823859
|
2.000 Hours
Interval 1.0 to 6.0
|
2.000 Hours
Interval 1.0 to 2.0
|
—
|
SECONDARY outcome
Timeframe: Pre dose on Day 1; 1, 2, 6, 12, 24, 48 and 96 hours post-dose on Day 1; Anytime during site visit at Day 15, 29, 43, 57, 71, 99, 127, 157Population: PK parameter set included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and who had at least 1 of the PK parameters of PF-06823859 of interest calculated.
AUCinf was calculated as AUClast + (Clast\*/kel), where Clast\* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel = terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Area under the curve from time zero to last quantifiable concentration (AUClast) was determined using the linear/log trapezoidal rule. AUCinf was analyzed and reported consolidated for all the time-points through Day 1 to Day 157.
Outcome measures
| Measure |
Cohort 1: PF-06823859 300 mg
n=5 Participants
Participants were randomized and administered a single dose of PF-06823859 300 mg as 60 minute IV infusion using a calibrated infusion pump on Day 1 of Cohort 1. Participants were followed up to Day 157.
|
Cohort 2: PF-06823859 900 mg
n=5 Participants
Participants were randomized and administered a single dose of PF-06823859 900 mg as 60 minute IV infusion using a calibrated infusion pump on Day 1 of Cohort 2. Participants were followed up to Day 157.
|
Placebo
Participants who were randomized and administered placebo as 60 minute IV infusion using a calibrated infusion pump on Day 1 of each Cohort 1 and Cohort 2 respectively were included in this reporting arm. Participants were followed up to Day 157 (relative to Day 1 of each Cohort).
|
|---|---|---|---|
|
Area Under the Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06823859
|
68070 Microgram*hour per milliliter
Geometric Coefficient of Variation 12
|
178000 Microgram*hour per milliliter
Geometric Coefficient of Variation 16
|
—
|
SECONDARY outcome
Timeframe: Pre dose on Day 1; 1, 2, 6, 12, 24, 48 and 96 hours post-dose on Day 1; Anytime during site visit at Day 15, 29, 43, 57, 71, 99, 127, 157Population: PK parameter set included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and who had at least 1 of the PK parameters of PF-06823859 of interest calculated.
AUCinf (dn) was calculated as AUCinf/dose. Where AUCinf was calculated as AUClast + (Clast\*/kel), where Clast\* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel = terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. AUClast was determined using the linear/log trapezoidal rule. AUCinf \[dn\] was analyzed and reported consolidated for all the time-points through Day 1 to Day 157.
Outcome measures
| Measure |
Cohort 1: PF-06823859 300 mg
n=5 Participants
Participants were randomized and administered a single dose of PF-06823859 300 mg as 60 minute IV infusion using a calibrated infusion pump on Day 1 of Cohort 1. Participants were followed up to Day 157.
|
Cohort 2: PF-06823859 900 mg
n=5 Participants
Participants were randomized and administered a single dose of PF-06823859 900 mg as 60 minute IV infusion using a calibrated infusion pump on Day 1 of Cohort 2. Participants were followed up to Day 157.
|
Placebo
Participants who were randomized and administered placebo as 60 minute IV infusion using a calibrated infusion pump on Day 1 of each Cohort 1 and Cohort 2 respectively were included in this reporting arm. Participants were followed up to Day 157 (relative to Day 1 of each Cohort).
|
|---|---|---|---|
|
Dose Normalized AUCinf (AUCinf [dn]) of PF-06823859
|
227.1 Microgram*hour/milliliter/milligram
Geometric Coefficient of Variation 12
|
197.8 Microgram*hour/milliliter/milligram
Geometric Coefficient of Variation 16
|
—
|
SECONDARY outcome
Timeframe: Pre dose on Day 1; 1, 2, 6, 12, 24, 48 and 96 hours post-dose on Day 1; Anytime during site visit at Day 15, 29, 43, 57, 71, 99, 127, 157Population: PK parameter set included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and who had at least 1 of the PK parameters of PF-06823859 of interest calculated.
AUClast was determined using the linear/log trapezoidal rule. AUClast was analyzed and reported consolidated for all the time-points through Day 1 to Day 157.
Outcome measures
| Measure |
Cohort 1: PF-06823859 300 mg
n=5 Participants
Participants were randomized and administered a single dose of PF-06823859 300 mg as 60 minute IV infusion using a calibrated infusion pump on Day 1 of Cohort 1. Participants were followed up to Day 157.
|
Cohort 2: PF-06823859 900 mg
n=5 Participants
Participants were randomized and administered a single dose of PF-06823859 900 mg as 60 minute IV infusion using a calibrated infusion pump on Day 1 of Cohort 2. Participants were followed up to Day 157.
|
Placebo
Participants who were randomized and administered placebo as 60 minute IV infusion using a calibrated infusion pump on Day 1 of each Cohort 1 and Cohort 2 respectively were included in this reporting arm. Participants were followed up to Day 157 (relative to Day 1 of each Cohort).
|
|---|---|---|---|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06823859
|
66120 Microgram*hour per milliliter
Geometric Coefficient of Variation 12
|
173000 Microgram*hour per milliliter
Geometric Coefficient of Variation 14
|
—
|
SECONDARY outcome
Timeframe: Pre dose on Day 1; 1, 2, 6, 12, 24, 48 and 96 hours post-dose on Day 1; Anytime during site visit at Day 15, 29, 43, 57, 71, 99, 127, 157Population: PK parameter set included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and who had at least 1 of the PK parameters of PF-06823859 of interest calculated.
AUClast(dn) was calculated as AUClast/dose. AUClast(dn) was analyzed and reported consolidated for all the time-points through Day 1 to Day 157.
Outcome measures
| Measure |
Cohort 1: PF-06823859 300 mg
n=5 Participants
Participants were randomized and administered a single dose of PF-06823859 300 mg as 60 minute IV infusion using a calibrated infusion pump on Day 1 of Cohort 1. Participants were followed up to Day 157.
|
Cohort 2: PF-06823859 900 mg
n=5 Participants
Participants were randomized and administered a single dose of PF-06823859 900 mg as 60 minute IV infusion using a calibrated infusion pump on Day 1 of Cohort 2. Participants were followed up to Day 157.
|
Placebo
Participants who were randomized and administered placebo as 60 minute IV infusion using a calibrated infusion pump on Day 1 of each Cohort 1 and Cohort 2 respectively were included in this reporting arm. Participants were followed up to Day 157 (relative to Day 1 of each Cohort).
|
|---|---|---|---|
|
Dose Normalized AUClast (AUClast [dn]) of PF-06823859
|
220.4 Microgram*hour/milliliter/milligram
Geometric Coefficient of Variation 12
|
192.2 Microgram*hour/milliliter/milligram
Geometric Coefficient of Variation 14
|
—
|
SECONDARY outcome
Timeframe: Pre dose on Day 1; 1, 2, 6, 12, 24, 48, 96 and 336 hours post dose on Day 1Population: PK parameter set included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and who had at least 1 of the PK parameters of PF-06823859 of interest calculated.
AUC14day = area under the serum concentration-time profile from time 0 to 14 days post-dose. AUC14day was determined using the linear/log trapezoidal rule. AUC14day was analyzed and reported consolidated for all the time-points through Day 1 to Day 14.
Outcome measures
| Measure |
Cohort 1: PF-06823859 300 mg
n=5 Participants
Participants were randomized and administered a single dose of PF-06823859 300 mg as 60 minute IV infusion using a calibrated infusion pump on Day 1 of Cohort 1. Participants were followed up to Day 157.
|
Cohort 2: PF-06823859 900 mg
n=5 Participants
Participants were randomized and administered a single dose of PF-06823859 900 mg as 60 minute IV infusion using a calibrated infusion pump on Day 1 of Cohort 2. Participants were followed up to Day 157.
|
Placebo
Participants who were randomized and administered placebo as 60 minute IV infusion using a calibrated infusion pump on Day 1 of each Cohort 1 and Cohort 2 respectively were included in this reporting arm. Participants were followed up to Day 157 (relative to Day 1 of each Cohort).
|
|---|---|---|---|
|
Area Under the Curve From Time Zero to 14 Days (336 Hours) Post-Dose (AUC14day) of PF-06823859
|
22170 Microgram*hour per milliliter
Geometric Coefficient of Variation 10
|
61170 Microgram*hour per milliliter
Geometric Coefficient of Variation 8
|
—
|
SECONDARY outcome
Timeframe: Pre dose on Day 1; 1, 2, 6, 12, 24, 48, 96, 336 and 672 hours post dose on Day 1Population: PK parameter set included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and who had at least 1 of the PK parameters of PF-06823859 of interest calculated.
AUC28day = area under the serum concentration-time profile from time 0 to 28 days post-dose. AUC28day was determined using the linear/log trapezoidal rule. AUC28day was analyzed and reported consolidated for all the time-points through Day 1 to Day 28.
Outcome measures
| Measure |
Cohort 1: PF-06823859 300 mg
n=5 Participants
Participants were randomized and administered a single dose of PF-06823859 300 mg as 60 minute IV infusion using a calibrated infusion pump on Day 1 of Cohort 1. Participants were followed up to Day 157.
|
Cohort 2: PF-06823859 900 mg
n=5 Participants
Participants were randomized and administered a single dose of PF-06823859 900 mg as 60 minute IV infusion using a calibrated infusion pump on Day 1 of Cohort 2. Participants were followed up to Day 157.
|
Placebo
Participants who were randomized and administered placebo as 60 minute IV infusion using a calibrated infusion pump on Day 1 of each Cohort 1 and Cohort 2 respectively were included in this reporting arm. Participants were followed up to Day 157 (relative to Day 1 of each Cohort).
|
|---|---|---|---|
|
Area Under the Curve From Time Zero to 28 Days (672 Hours) Post-Dose (AUC28day) of PF-06823859
|
35040 Microgram*hour per milliliter
Geometric Coefficient of Variation 10
|
95250 Microgram*hour per milliliter
Geometric Coefficient of Variation 10
|
—
|
SECONDARY outcome
Timeframe: Pre dose on Day 1; 1, 2, 6, 12, 24, 48 and 96 hours post-dose on Day 1; Anytime during site visit at Day 15, 29, 43, 57, 71, 99, 127, 157Population: PK parameter set included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and who had at least 1 of the PK parameters of PF-06823859 of interest calculated.
Terminal half-life (t1/2) is the time for the serum concentration of a drug to decrease by half of its initial concentration. T1/2 was determined using loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. T1/2 was analyzed and reported consolidated for all the time-points through Day 1 to Day 157.
Outcome measures
| Measure |
Cohort 1: PF-06823859 300 mg
n=5 Participants
Participants were randomized and administered a single dose of PF-06823859 300 mg as 60 minute IV infusion using a calibrated infusion pump on Day 1 of Cohort 1. Participants were followed up to Day 157.
|
Cohort 2: PF-06823859 900 mg
n=5 Participants
Participants were randomized and administered a single dose of PF-06823859 900 mg as 60 minute IV infusion using a calibrated infusion pump on Day 1 of Cohort 2. Participants were followed up to Day 157.
|
Placebo
Participants who were randomized and administered placebo as 60 minute IV infusion using a calibrated infusion pump on Day 1 of each Cohort 1 and Cohort 2 respectively were included in this reporting arm. Participants were followed up to Day 157 (relative to Day 1 of each Cohort).
|
|---|---|---|---|
|
Terminal Half-Life (t1/2) of PF-06823859
|
32.42 Days
Standard Deviation 0.70852
|
31.42 Days
Standard Deviation 4.9505
|
—
|
SECONDARY outcome
Timeframe: Pre dose on Day 1; 1, 2, 6, 12, 24, 48 and 96 hours post-dose on Day 1; Anytime during site visit at Day 15, 29, 43, 57, 71, 99, 127, 157Population: PK parameter set included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and who had at least 1 of the PK parameters of PF-06823859 of interest calculated.
CL was calculated as Dose divided by AUCinf. AUCinf was calculated as AUClast + (Clast\*/kel), where Clast\* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel = terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. AUClast was determined using the linear/log trapezoidal rule. CL was analyzed and reported consolidated for all the time-points through Day 1 to Day 157.
Outcome measures
| Measure |
Cohort 1: PF-06823859 300 mg
n=5 Participants
Participants were randomized and administered a single dose of PF-06823859 300 mg as 60 minute IV infusion using a calibrated infusion pump on Day 1 of Cohort 1. Participants were followed up to Day 157.
|
Cohort 2: PF-06823859 900 mg
n=5 Participants
Participants were randomized and administered a single dose of PF-06823859 900 mg as 60 minute IV infusion using a calibrated infusion pump on Day 1 of Cohort 2. Participants were followed up to Day 157.
|
Placebo
Participants who were randomized and administered placebo as 60 minute IV infusion using a calibrated infusion pump on Day 1 of each Cohort 1 and Cohort 2 respectively were included in this reporting arm. Participants were followed up to Day 157 (relative to Day 1 of each Cohort).
|
|---|---|---|---|
|
Systemic Clearance (CL) of PF-06823859
|
0.004406 Liter per hour
Geometric Coefficient of Variation 12
|
0.005061 Liter per hour
Geometric Coefficient of Variation 16
|
—
|
SECONDARY outcome
Timeframe: Pre dose on Day 1; 1, 2, 6, 12, 24, 48 and 96 hours post-dose on Day 1; Anytime during site visit at Day 15, 29, 43, 57, 71, 99, 127, 157Population: PK parameter set included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and who had at least 1 of the PK parameters of PF-06823859 of interest calculated.
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Vss was calculated as CL\*Mean residence time (MRT). MRT was calculated as AUMCinf/AUCinf - DOF/2, where AUMCinf is the area under the moment curve from time 0 extrapolated to infinity and DOF is the duration of the IV infusion. Vss was analyzed and reported consolidated for all the time-points through Day 1 to Day 157.
Outcome measures
| Measure |
Cohort 1: PF-06823859 300 mg
n=5 Participants
Participants were randomized and administered a single dose of PF-06823859 300 mg as 60 minute IV infusion using a calibrated infusion pump on Day 1 of Cohort 1. Participants were followed up to Day 157.
|
Cohort 2: PF-06823859 900 mg
n=5 Participants
Participants were randomized and administered a single dose of PF-06823859 900 mg as 60 minute IV infusion using a calibrated infusion pump on Day 1 of Cohort 2. Participants were followed up to Day 157.
|
Placebo
Participants who were randomized and administered placebo as 60 minute IV infusion using a calibrated infusion pump on Day 1 of each Cohort 1 and Cohort 2 respectively were included in this reporting arm. Participants were followed up to Day 157 (relative to Day 1 of each Cohort).
|
|---|---|---|---|
|
Steady-State Volume of Distribution (Vss) of PF-06823859
|
4.304 Liter
Geometric Coefficient of Variation 10
|
4.737 Liter
Geometric Coefficient of Variation 7
|
—
|
SECONDARY outcome
Timeframe: Pre dose on Day 1; 1, 2, 6, 12, 24, 48 and 96 hours post-dose on Day 1; Anytime during site visit at Day 15, 29, 43, 57, 71, 99, 127, 157Population: PK parameter set included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and who had at least 1 of the PK parameters of PF-06823859 of interest calculated.
MRT was calculated as AUMCinf/AUCinf - DOF/2, where AUMCinf is the area under the moment curve from time 0 extrapolated to infinity and DOF is the duration of the IV infusion. MRT was analyzed and reported consolidated for all the time-points through Day 1 to Day 157.
Outcome measures
| Measure |
Cohort 1: PF-06823859 300 mg
n=5 Participants
Participants were randomized and administered a single dose of PF-06823859 300 mg as 60 minute IV infusion using a calibrated infusion pump on Day 1 of Cohort 1. Participants were followed up to Day 157.
|
Cohort 2: PF-06823859 900 mg
n=5 Participants
Participants were randomized and administered a single dose of PF-06823859 900 mg as 60 minute IV infusion using a calibrated infusion pump on Day 1 of Cohort 2. Participants were followed up to Day 157.
|
Placebo
Participants who were randomized and administered placebo as 60 minute IV infusion using a calibrated infusion pump on Day 1 of each Cohort 1 and Cohort 2 respectively were included in this reporting arm. Participants were followed up to Day 157 (relative to Day 1 of each Cohort).
|
|---|---|---|---|
|
Mean Residence Time (MRT) of PF-06823859
|
40.69 Days
Geometric Coefficient of Variation 8
|
38.99 Days
Geometric Coefficient of Variation 15
|
—
|
SECONDARY outcome
Timeframe: Day 1 maximum up to Day 157Population: Immunogenicity analysis set included all participants randomly assigned to study intervention who received at least 1 dose of study intervention with at least 1 post-treatment anti-drug (PF-06823859) antibody determination. Data for this outcome measure was not planned to be collected and analyzed for placebo arm.
A participant was ADA positive if (1) baseline ADA titer was missing or negative and participant had \>= 1 post-treatment positive titer (treatment-induced), or (2) positive ADA titer at baseline and had a \>= 0.602 unit increase in titer from baseline in \>= 1 post-treatment sample (treatment-boosted). A participant was NAb positive, if baseline was missing or negative and participant had \>= 1 post-treatment positive. NAb-negative participants included participants who were ADA negative or ADA-positive participants tested post-treatment negative in the NAb assay. Participants who were NAb positive at baseline and had \>= 1 post-treatment positive were handled as NAb negative.
Outcome measures
| Measure |
Cohort 1: PF-06823859 300 mg
n=5 Participants
Participants were randomized and administered a single dose of PF-06823859 300 mg as 60 minute IV infusion using a calibrated infusion pump on Day 1 of Cohort 1. Participants were followed up to Day 157.
|
Cohort 2: PF-06823859 900 mg
n=5 Participants
Participants were randomized and administered a single dose of PF-06823859 900 mg as 60 minute IV infusion using a calibrated infusion pump on Day 1 of Cohort 2. Participants were followed up to Day 157.
|
Placebo
Participants who were randomized and administered placebo as 60 minute IV infusion using a calibrated infusion pump on Day 1 of each Cohort 1 and Cohort 2 respectively were included in this reporting arm. Participants were followed up to Day 157 (relative to Day 1 of each Cohort).
|
|---|---|---|---|
|
Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibodies (NAb) for PF-06823859
Positive ADA
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibodies (NAb) for PF-06823859
Positive NAb
|
1 Participants
|
1 Participants
|
—
|
Adverse Events
Cohort 1: PF-06823859 300 mg
Cohort 2: PF-06823859 900 mg
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1: PF-06823859 300 mg
n=5 participants at risk
Participants were randomized and administered a single dose of PF-06823859 300 mg as 60 minute IV infusion using a calibrated infusion pump on Day 1 of Cohort 1. Participants were followed up to Day 157.
|
Cohort 2: PF-06823859 900 mg
n=5 participants at risk
Participants were randomized and administered a single dose of PF-06823859 900 mg as 60 minute IV infusion using a calibrated infusion pump on Day 1 of Cohort 2. Participants were followed up to Day 157.
|
Placebo
n=2 participants at risk
Participants who were randomized and administered placebo as 60 minute IV infusion using a calibrated infusion pump on Day 1 of each Cohort 1 and Cohort 2 respectively were included in this reporting arm. Participants were followed up to Day 157 (relative to Day 1 of each Cohort).
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain lower
|
20.0%
1/5 • Day 1 up to maximum of Day 157
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Day 1 up to maximum of Day 157
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Day 1 up to maximum of Day 157
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
General disorders
Vaccination site pain
|
20.0%
1/5 • Day 1 up to maximum of Day 157
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Day 1 up to maximum of Day 157
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Day 1 up to maximum of Day 157
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/5 • Day 1 up to maximum of Day 157
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
20.0%
1/5 • Day 1 up to maximum of Day 157
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Day 1 up to maximum of Day 157
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
20.0%
1/5 • Day 1 up to maximum of Day 157
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Day 1 up to maximum of Day 157
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Day 1 up to maximum of Day 157
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
20.0%
1/5 • Day 1 up to maximum of Day 157
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Day 1 up to maximum of Day 157
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Day 1 up to maximum of Day 157
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/5 • Day 1 up to maximum of Day 157
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
20.0%
1/5 • Day 1 up to maximum of Day 157
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Day 1 up to maximum of Day 157
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/5 • Day 1 up to maximum of Day 157
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
20.0%
1/5 • Day 1 up to maximum of Day 157
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Day 1 up to maximum of Day 157
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/5 • Day 1 up to maximum of Day 157
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
20.0%
1/5 • Day 1 up to maximum of Day 157
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Day 1 up to maximum of Day 157
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
20.0%
1/5 • Day 1 up to maximum of Day 157
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Day 1 up to maximum of Day 157
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Day 1 up to maximum of Day 157
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
Additional Information
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