Healthy
Conditions
Brief summary
The purpose of this clinical trial is to learn if the study medicine (called PF-06823859) is safe and how it is processed in healthy Chinese participants. This study is seeking participants who: * Are between 18 to 45 years of age, inclusive, at the time of signing the Informed Consent Document (ICD). * Are Chinese participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and 12 lead ECG (electrocardiogram). * Have a BMI (body mass index) of 19 to 27 kg/m2 (inclusive); and a total body weight \>50 kg (110 lb). All participants in this study will receive PF-06823859 or a placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. PF-06823859 will be given as an infusion directly into a vein. We will compare the experiences of people receiving PF-06823859 to those of people who do not. This will help us determine if PF-06823859 is safe and how it behaves inside the human body. Participants will take part in this study for up to 157 days. During this time, they will receive PF-06823859 or placebo and be observed for any effects.
Detailed description
This is a Phase 1, randomized, double blind, sponsor open, placebo controlled study to evaluate the PK, safety, and tolerability following a single dose of PF 06823859 (900 mg) in healthy Chinese participants.
Interventions
DRUGIFN-β inhibitor treatment
PF-06823859 (IFN-β inhibitor) 100 mg/mL solution for injection
OTHERPlacebo
Placebo for PF-06823859, 0 mg/mL solution for injection
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1.1. Inclusion Criteria 1. Male and female participants must be 18 to 45 years of age, inclusive, at the time of signing the ICD (informed consent document). 2. Male and female Chinese participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and 12 lead ECG (electrocardiogram). 3. BMI (body mass index) of 19 to 27 kg/m2 (inclusive); and a total body weight \>50 kg (110 lb). 1.2.
Exclusion criteria
1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease. 2. History of HIV (human immunodeficiency virus) infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg (hepatitis B surface antigen), or HCVAb (hepatitis C antibody). 3. History of autoimmune disorders. 4. History of allergic or anaphylactic reaction to a therapeutic drug. 5. History of recent active infections within 28 days prior to the screening visit. 6. Participants with a fever within 7 days prior to dosing. 7. Infected with Mycobacterium TB (tuberculosis) 8. Contact with positive case of COVID (coronavirus disease)-19 or travel to an area defined as high risk by relevant authority in the past 14 days. 9. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. 10. Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study intervention. 11. Current use of any prohibited concomitant medication(s) or those unwilling/unable to use a permitted concomitant medication(s).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Viral Infections | From Screening up to Day157 | Viral infections surveillance was conducted throughout the study for cytomegalovirus (CMV), Epstein Barr virus (EBV), herpes simplex virus type 1 (HSV-1),herpes simplex virus type 2 (HSV-2), varicella zoster virus (VZV)， Human Herpes Virus 6 (HHV6) and COVID-19. |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From first dose of study drug/Day 1 to Day 157 | An 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. A serious AE (SAE) was defined as any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; or other serious situations such as important medical events. TEAEs were events between first dose of study drug and up to follow-up visit that were absent before treatment or that worsened after treatment. AEs presented below were TEAEs. The investigator was required to use clinical judgment to assess the potential relationship between investigational product and each AE, to define an treatment-related AE. |
| Number of Participants With Pre-Specified Categorization for Vital Signs (Diastolic Blood Pressure) | Days 1 (pre-dose),5,29,57,100,127 and 157. | Vital signs measurements included supine blood pressure, diastolic blood pressure, pulse rate and temperature. For diastolic blood pressure, the reporting criteria is increase or decrease from baseline of \>= 20mmHg or absolute value \< 50 mmHg. |
| Number of Participants With Pre-Specified Categorization for Vital Signs (Systolic Blood Pressure) | Days 1 (pre-dose),5,29,57,100,127 and 157. | Vital signs measurements included supine blood pressure, diastolic blood pressure, pulse rate and temperature. For systolic blood pressure, the reporting criteria is increase or decrease from baseline of \>= 30 mm Hg or absolute value of \<90 mmHg |
| Number of Participants With Pre-Specified Categorization (Maximum Change From Baseline) for ECG Data | Days -1, 5,29,57,100,127 and 157. | Standard 12 lead ECGs utilizing limb leads (with a 10 second rhythm strip) were collected at pre-specified times using an ECG machine that automatically calculates the heart rate and measures PR, QT, and QTc intervals and QRS complex. For Safely QTc assessments, absolute value of \>450msec and \< 480msec is defined as mild prolongation; absolute value between 480-500msec or an increase from baseline of 30 -60msec are defined as moderate prolongation; an absolute value of \> 500msec or increase from baseline of \>60 msec are defined as severe prolongation. |
| Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality). | Days -1, 2, 5,8,15,29,57,100,127 and 157. | Safety laboratory assessments included urinalysis, hematology, chemistry and other. All the safety laboratory samples were collected following at least a 4-hour fast. |
| Maximum Serum Concentration(Cmax) for PF-06823859 | Days 1 (pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157. | The Cmax was observed directly from data. |
| Time at Which Cmax Occured (Tmax) for PF-06823859 in Serum | Days 1 (pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157. | The Tmax was the time at which Cmax occurs |
| Area Under the Concentration-time Profile From Time Zero to 14 Days (336 Hours) Post-dose (AUC14day) for PF-06823859 in Serum | Days 1 (pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157. | The AUC14day was area under the concentration-time profile from time zero to 14 days post-dose (336 hours) |
| Area Under the Concentration-time Profile From Time Zero to 28 Days (672 Hours) Post-dose (AUC28day) for PF-06823859 in Serum | Days 1(pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157. | The AUC28day was area under the concentration-time profile from time zero to 28 days post-dose (672 hours) |
| Area Under the Serum Concentration-time Profile From Time Zero Extrapolated to Infinite Time(AUCinf) for PF-06823859 in Serum. | Days 1(pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157. | The AUCinf was area under the serum concentration-time profile from time zero extrapolated to infinite time |
| Terminal Half-life (t1/2) for PF-06823859 in Serum. | Days 1(pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157. | The t1/2 was terminal half-life (time required for the plasma concentration to decline by 50%). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clearance(CL) for PF-06823859 in Serum | Days 1(pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157. | The CL was clearance. |
| Volume of Distribution at Steady State (Vss) for PF-06823859 in Serum | Days 1(pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157. | The Vss was volume of distribution. |
| Mean Residence Time (MRT) for PF-06823859 in Serum | Days 1(pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157. | The MRT was mean residence time. |
| Number of Participants With Positive Anti-drug Antibody (ADA) of PF-06823859 | Days 1 (pre-dose), 15,29, 57, 71, 100, 127 and 157. | The percentage of participants with positive ADA was summarized. |
| Area Under the Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (Clast) (AUClast) for PF-06823859 in Serum | Days 1(pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157. | The AUClast was area under the serum concentration-time profile from time zero to the time of the last quantifiable concentration (Clast) |
Countries
China
Participant flow
Pre-assignment details
There were 83 participants screened in the study, among whom, 18 participants were assigned to the study treatments.
Participants by arm
| Arm | Count |
|---|---|
| PF-06823859 900mg Participants received a single intravenous (IV) infusion of PF-06823859 900 mg on Study Day 1. | 15 |
| Placebo Participants received a single IV infusion of placebo on Study Day 1 | 3 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Follow-up Phase | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | PF-06823859 900mg | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 33.00 years | 28.00 years | 30.50 years |
| Race/Ethnicity, Customized Chinese | 15 Participants | 3 Participants | 18 Participants |
| Sex: Female, Male Female | 2 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Male | 13 Participants | 3 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 3 |
| other Total, other adverse events | 14 / 15 | 2 / 3 |
| serious Total, serious adverse events | 0 / 15 | 0 / 3 |
Outcome results
Primary
Area Under the Concentration-time Profile From Time Zero to 14 Days (336 Hours) Post-dose (AUC14day) for PF-06823859 in Serum
The AUC14day was area under the concentration-time profile from time zero to 14 days post-dose (336 hours)
Time frame: Days 1 (pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157.
Population: The PK parameter analysis population included all randomized participants who received at least 1 dose of study intervention and at least 1 of the PK parameters was calculated.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-06823859 900 mg | Area Under the Concentration-time Profile From Time Zero to 14 Days (336 Hours) Post-dose (AUC14day) for PF-06823859 in Serum | 48550 ug*hr/mL | Geometric Coefficient of Variation 16 |
Primary
Area Under the Concentration-time Profile From Time Zero to 28 Days (672 Hours) Post-dose (AUC28day) for PF-06823859 in Serum
The AUC28day was area under the concentration-time profile from time zero to 28 days post-dose (672 hours)
Time frame: Days 1(pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157.
Population: The PK parameter analysis population included all randomized participants who received at least 1 dose of study intervention and at least 1 of the PK parameters was calculated.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-06823859 900 mg | Area Under the Concentration-time Profile From Time Zero to 28 Days (672 Hours) Post-dose (AUC28day) for PF-06823859 in Serum | 73240 ug*hr/mL | Geometric Coefficient of Variation 17 |
Primary
Area Under the Serum Concentration-time Profile From Time Zero Extrapolated to Infinite Time(AUCinf) for PF-06823859 in Serum.
The AUCinf was area under the serum concentration-time profile from time zero extrapolated to infinite time
Time frame: Days 1(pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157.
Population: The PK parameter analysis population included all randomized participants who received at least 1 dose of study intervention and at least 1 of the PK parameters was calculated.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-06823859 900 mg | Area Under the Serum Concentration-time Profile From Time Zero Extrapolated to Infinite Time(AUCinf) for PF-06823859 in Serum. | 127100 ug*hr/mL | Geometric Coefficient of Variation 23 |
Primary
Maximum Serum Concentration(Cmax) for PF-06823859
The Cmax was observed directly from data.
Time frame: Days 1 (pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157.
Population: The PK parameter analysis population included all randomized participants who received at least 1 dose of study intervention and at least 1 of the PK parameters was calculated.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-06823859 900 mg | Maximum Serum Concentration(Cmax) for PF-06823859 | 307.4 micrograms/milliliter (ug/mL) | Geometric Coefficient of Variation 17 |
Primary
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality).
Safety laboratory assessments included urinalysis, hematology, chemistry and other. All the safety laboratory samples were collected following at least a 4-hour fast.
Time frame: Days -1, 2, 5,8,15,29,57,100,127 and 157.
Population: The safety analysis population included all randomized participants who received at least 1 dose of the study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06823859 900 mg | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality). | Ery. Mean Corpuscular HGB Concentration (g/L) < 0.9 ✖ Lower Limit Normal (LLN) | 1 Participants |
| PF-06823859 900 mg | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality). | Lymphocytes (10^9/L) > 1.2 ✖ Upper Limit Normal (ULN) | 1 Participants |
| PF-06823859 900 mg | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality). | Basophils (10^9/L) > 1.2 ✖ ULN | 1 Participants |
| PF-06823859 900 mg | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality). | Eosinophils (10^9/L) > 1.2 ✖ ULN | 1 Participants |
| PF-06823859 900 mg | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality). | Prothrombin Time (s) > 1.1 ✖ ULN | 1 Participants |
| PF-06823859 900 mg | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality). | Bilirubin (micromol/L) > 1.5 ✖ ULN | 1 Participants |
| PF-06823859 900 mg | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality). | Urate (mmol/L) > 1.2 ✖ ULN | 1 Participants |
| PF-06823859 900 mg | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality). | pH (Scalar) >8 | 1 Participants |
| PF-06823859 900 mg | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality). | URINE Erythrocytes (Scalar) >= 20 | 2 Participants |
| PF-06823859 900 mg | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality). | URINE Leukocytes (Scalar) >= 20 | 2 Participants |
| PF-06823859 900 mg | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality). | Ketones >= 1 | 1 Participants |
| PF-06823859 900 mg | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality). | URINE Hemoglobin >= 1 | 2 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality). | Ketones >= 1 | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality). | Ery. Mean Corpuscular HGB Concentration (g/L) < 0.9 ✖ Lower Limit Normal (LLN) | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality). | Urate (mmol/L) > 1.2 ✖ ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality). | Lymphocytes (10^9/L) > 1.2 ✖ Upper Limit Normal (ULN) | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality). | URINE Leukocytes (Scalar) >= 20 | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality). | Basophils (10^9/L) > 1.2 ✖ ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality). | pH (Scalar) >8 | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality). | Eosinophils (10^9/L) > 1.2 ✖ ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality). | URINE Hemoglobin >= 1 | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality). | Prothrombin Time (s) > 1.1 ✖ ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality). | URINE Erythrocytes (Scalar) >= 20 | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality). | Bilirubin (micromol/L) > 1.5 ✖ ULN | 0 Participants |
Primary
Number of Participants With Pre-Specified Categorization for Vital Signs (Diastolic Blood Pressure)
Vital signs measurements included supine blood pressure, diastolic blood pressure, pulse rate and temperature. For diastolic blood pressure, the reporting criteria is increase or decrease from baseline of \>= 20mmHg or absolute value \< 50 mmHg.
Time frame: Days 1 (pre-dose),5,29,57,100,127 and 157.
Population: The safety analysis population included all randomized participants who received at least 1 dose of the study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PF-06823859 900 mg | Number of Participants With Pre-Specified Categorization for Vital Signs (Diastolic Blood Pressure) | 1 Participants |
| Placebo | Number of Participants With Pre-Specified Categorization for Vital Signs (Diastolic Blood Pressure) | 0 Participants |
Primary
Number of Participants With Pre-Specified Categorization for Vital Signs (Systolic Blood Pressure)
Vital signs measurements included supine blood pressure, diastolic blood pressure, pulse rate and temperature. For systolic blood pressure, the reporting criteria is increase or decrease from baseline of \>= 30 mm Hg or absolute value of \<90 mmHg
Time frame: Days 1 (pre-dose),5,29,57,100,127 and 157.
Population: The safety analysis population included all randomized participants who received at least 1 dose of the study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06823859 900 mg | Number of Participants With Pre-Specified Categorization for Vital Signs (Systolic Blood Pressure) | Systolic Blood Pressure (mmHg) Change >= 30 mmHg increase | 1 Participants |
| PF-06823859 900 mg | Number of Participants With Pre-Specified Categorization for Vital Signs (Systolic Blood Pressure) | Systolic Blood Pressure (mmHg) Change >= 30 mmHg decrease | 1 Participants |
| Placebo | Number of Participants With Pre-Specified Categorization for Vital Signs (Systolic Blood Pressure) | Systolic Blood Pressure (mmHg) Change >= 30 mmHg increase | 0 Participants |
| Placebo | Number of Participants With Pre-Specified Categorization for Vital Signs (Systolic Blood Pressure) | Systolic Blood Pressure (mmHg) Change >= 30 mmHg decrease | 0 Participants |
Primary
Number of Participants With Pre-Specified Categorization (Maximum Change From Baseline) for ECG Data
Standard 12 lead ECGs utilizing limb leads (with a 10 second rhythm strip) were collected at pre-specified times using an ECG machine that automatically calculates the heart rate and measures PR, QT, and QTc intervals and QRS complex. For Safely QTc assessments, absolute value of \>450msec and \< 480msec is defined as mild prolongation; absolute value between 480-500msec or an increase from baseline of 30 -60msec are defined as moderate prolongation; an absolute value of \> 500msec or increase from baseline of \>60 msec are defined as severe prolongation.
Time frame: Days -1, 5,29,57,100,127 and 157.
Population: The safety analysis population included all randomized participants who received at least 1 dose of the study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PF-06823859 900 mg | Number of Participants With Pre-Specified Categorization (Maximum Change From Baseline) for ECG Data | 0 Participants |
| Placebo | Number of Participants With Pre-Specified Categorization (Maximum Change From Baseline) for ECG Data | 0 Participants |
Primary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An 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. A serious AE (SAE) was defined as any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; or other serious situations such as important medical events. TEAEs were events between first dose of study drug and up to follow-up visit that were absent before treatment or that worsened after treatment. AEs presented below were TEAEs. The investigator was required to use clinical judgment to assess the potential relationship between investigational product and each AE, to define an treatment-related AE.
Time frame: From first dose of study drug/Day 1 to Day 157
Population: The safety analysis population included all randomized participants who received at least 1 dose of the study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06823859 900 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Participants with TEAEs | 14 Participants |
| PF-06823859 900 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Participants with serious TEAEs | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Participants with TEAEs | 2 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Participants with serious TEAEs | 0 Participants |
Primary
Number of Participants With Viral Infections
Viral infections surveillance was conducted throughout the study for cytomegalovirus (CMV), Epstein Barr virus (EBV), herpes simplex virus type 1 (HSV-1),herpes simplex virus type 2 (HSV-2), varicella zoster virus (VZV)， Human Herpes Virus 6 (HHV6) and COVID-19.
Time frame: From Screening up to Day157
Population: The safety analysis population included all randomized participants who received at least 1 dose of the study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PF-06823859 900 mg | Number of Participants With Viral Infections | 3 Participants |
| Placebo | Number of Participants With Viral Infections | 0 Participants |
Primary
Terminal Half-life (t1/2) for PF-06823859 in Serum.
The t1/2 was terminal half-life (time required for the plasma concentration to decline by 50%).
Time frame: Days 1(pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157.
Population: The analysis population included all randomized participants who received at least 1 dose of study intervention and at least 1 of the PK parameters was calculated.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-06823859 900 mg | Terminal Half-life (t1/2) for PF-06823859 in Serum. | 26.96 day | Standard Deviation 2.6945 |
Primary
Time at Which Cmax Occured (Tmax) for PF-06823859 in Serum
The Tmax was the time at which Cmax occurs
Time frame: Days 1 (pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157.
Population: The PK parameter analysis population included all randomized participants who received at least 1 dose of study intervention and at least 1 of the PK parameters was calculated.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PF-06823859 900 mg | Time at Which Cmax Occured (Tmax) for PF-06823859 in Serum | 1.52 hour (hr) |
Secondary
Area Under the Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (Clast) (AUClast) for PF-06823859 in Serum
The AUClast was area under the serum concentration-time profile from time zero to the time of the last quantifiable concentration (Clast)
Time frame: Days 1(pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157.
Population: The PK parameter analysis population included all randomized participants who received at least 1 dose of study intervention and at least 1 of the PK parameters was calculated.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-06823859 900 mg | Area Under the Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (Clast) (AUClast) for PF-06823859 in Serum | 124700 ug*hr/mL | Geometric Coefficient of Variation 23 |
Secondary
Clearance(CL) for PF-06823859 in Serum
The CL was clearance.
Time frame: Days 1(pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157.
Population: The PK parameter analysis population included all randomized participants who received at least 1 dose of study intervention and at least 1 of the PK parameters was calculated.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-06823859 900 mg | Clearance(CL) for PF-06823859 in Serum | 0.007084 L/hr | Geometric Coefficient of Variation 23 |
Secondary
Mean Residence Time (MRT) for PF-06823859 in Serum
The MRT was mean residence time.
Time frame: Days 1(pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157.
Population: The PK parameter analysis population included all randomized participants who received at least 1 dose of study intervention and at least 1 of the PK parameters was calculated.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-06823859 900 mg | Mean Residence Time (MRT) for PF-06823859 in Serum | 34.13 Day | Geometric Coefficient of Variation 17 |
Secondary
Number of Participants With Positive Anti-drug Antibody (ADA) of PF-06823859
The percentage of participants with positive ADA was summarized.
Time frame: Days 1 (pre-dose), 15,29, 57, 71, 100, 127 and 157.
Population: The immunogenicity analysis population included all randomized participants who received at least 1 dose of study intervention with at least 1 post-treatment anti-drug antibody determination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PF-06823859 900 mg | Number of Participants With Positive Anti-drug Antibody (ADA) of PF-06823859 | 0 Participants |
Secondary
Volume of Distribution at Steady State (Vss) for PF-06823859 in Serum
The Vss was volume of distribution.
Time frame: Days 1(pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157.
Population: The PK parameter analysis population included all randomized participants who received at least 1 dose of study intervention and at least 1 of the PK parameters was calculated.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-06823859 900 mg | Volume of Distribution at Steady State (Vss) for PF-06823859 in Serum | 5.800 L | Geometric Coefficient of Variation 18 |