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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-06823859 | Experimental | Participants will receive 900 mg of PF-06823859 via intravaneous (IV). |
|
| Placebo | Placebo Comparator | Participants will receive placebo via IV. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IFN-β inhibitor treatment | Drug | PF-06823859 (IFN-β inhibitor) 100 mg/mL solution for injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Serum Concentration(Cmax) for PF-06823859 | The Cmax was observed directly from data. | Days 1 (pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157. |
| Time at Which Cmax Occured (Tmax) for PF-06823859 in Serum | The Tmax was the time at which Cmax occurs | Days 1 (pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157. |
| 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) | Days 1 (pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157. |
| 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) | Days 1(pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157. |
| 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 | Days 1(pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157. |
| 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%). |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Days 1(pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157. |
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1.1. Inclusion Criteria
1.2. Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | Beijing Municipality | 100089 | China | ||
| Peking University Third Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40401504 | Derived | Chen N, Sano Y, Wang X, Hu S, Tabira J, Luo X, Yoshimatsu H, Prybylski J, Chu M, Li H, Takazawa K. Pharmacokinetics, Safety, and Tolerability of Single-Dose Dazukibart in Healthy Adults in China and Japan: Results From 2 Randomized, Double-Blind, Phase 1 Studies. Clin Pharmacol Drug Dev. 2025 Aug;14(8):572-582. doi: 10.1002/cpdd.1522. Epub 2025 May 22. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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There were 83 participants screened in the study, among whom, 18 participants were assigned to the study treatments.
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| ID | Title | Description |
|---|---|---|
| FG000 | PF-06823859 900mg | Participants received a single intravenous (IV) infusion of PF-06823859 900 mg on Study Day 1 |
| FG001 | Placebo | Participants received a single IV infusion of placebo on Study Day 1 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Phase |
| |||||||||||||
| Follow-up Phase |
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The baseline analysis population included all participants enrolled in the study
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| ID | Title | Description |
|---|---|---|
| BG000 | PF-06823859 900mg | Participants received a single intravenous (IV) infusion of PF-06823859 900 mg on Study Day 1. |
| BG001 | Placebo | Participants received a single IV infusion of placebo on Study Day 1 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Serum Concentration(Cmax) for PF-06823859 | The Cmax was observed directly from data. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms/milliliter (ug/mL) | Days 1 (pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157. |
|
|
From screening up to Day 157
Serious adverse events(SAE) and non-serious AEs were recorded on the case report form.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PF-06823859 900mg | Participants received a single intravenous (IV) infusion of PF-06823859 900 mg on Study Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 10, 2022 | Mar 6, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 9, 2022 | Mar 6, 2024 | SAP_001.pdf |
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| Placebo | Other | Placebo for PF-06823859, 0 mg/mL solution for injection |
|
| Days 1(pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157. |
| 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. | From first dose of study drug/Day 1 to Day 157 |
| 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. | Days 1 (pre-dose),5,29,57,100,127 and 157. |
| 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 | Days 1 (pre-dose),5,29,57,100,127 and 157. |
| 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. | Days -1, 5,29,57,100,127 and 157. |
| 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. | Days -1, 2, 5,8,15,29,57,100,127 and 157. |
| 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. | From Screening up to Day157 |
| Clearance(CL) for PF-06823859 in Serum | The CL was clearance. | Days 1(pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157. |
| Volume of Distribution at Steady State (Vss) for PF-06823859 in Serum | The Vss was volume of distribution. | Days 1(pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157. |
| Mean Residence Time (MRT) for PF-06823859 in Serum | The MRT was mean residence time. | Days 1(pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157. |
| Number of Participants With Positive Anti-drug Antibody (ADA) of PF-06823859 | The percentage of participants with positive ADA was summarized. | Days 1 (pre-dose), 15,29, 57, 71, 100, 127 and 157. |
| Beijing |
| Beijing Municipality |
| 100191 |
| China |
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | Time at Which Cmax Occured (Tmax) for PF-06823859 in Serum | The Tmax was the time at which Cmax occurs | 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. | Posted | Median | Full Range | hour (hr) | Days 1 (pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157. |
|
|
|
| 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) | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ug*hr/mL | Days 1 (pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157. |
|
|
|
| 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) | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ug*hr/mL | Days 1(pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157. |
|
|
|
| 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 | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ug*hr/mL | Days 1(pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157. |
|
|
|
| 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%). | 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. | Posted | Mean | Standard Deviation | day | Days 1(pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157. |
|
|
|
| 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. | The safety analysis population included all randomized participants who received at least 1 dose of the study intervention. | Posted | Count of Participants | Participants | From first dose of study drug/Day 1 to Day 157 |
|
|
|
| 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. | The safety analysis population included all randomized participants who received at least 1 dose of the study intervention. | Posted | Count of Participants | Participants | Days 1 (pre-dose),5,29,57,100,127 and 157. |
|
|
|
| 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 | The safety analysis population included all randomized participants who received at least 1 dose of the study intervention. | Posted | Count of Participants | Participants | Days 1 (pre-dose),5,29,57,100,127 and 157. |
|
|
|
| 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. | The safety analysis population included all randomized participants who received at least 1 dose of the study intervention. | Posted | Count of Participants | Participants | Days -1, 5,29,57,100,127 and 157. |
|
|
|
| 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. | The safety analysis population included all randomized participants who received at least 1 dose of the study intervention. | Posted | Count of Participants | Participants | Days -1, 2, 5,8,15,29,57,100,127 and 157. |
|
|
|
| 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. | The safety analysis population included all randomized participants who received at least 1 dose of the study intervention. | Posted | Count of Participants | Participants | From Screening up to Day157 |
|
|
|
| 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) | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ug*hr/mL | Days 1(pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157. |
|
|
|
| Secondary | Clearance(CL) for PF-06823859 in Serum | The CL was clearance. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/hr | Days 1(pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157. |
|
|
|
| Secondary | Volume of Distribution at Steady State (Vss) for PF-06823859 in Serum | The Vss was volume of distribution. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | L | Days 1(pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157. |
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|
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| Secondary | Mean Residence Time (MRT) for PF-06823859 in Serum | The MRT was mean residence time. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Day | Days 1(pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157. |
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| Secondary | Number of Participants With Positive Anti-drug Antibody (ADA) of PF-06823859 | The percentage of participants with positive ADA was summarized. | 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. | Posted | Count of Participants | Participants | Days 1 (pre-dose), 15,29, 57, 71, 100, 127 and 157. |
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|
| 0 |
| 15 |
| 0 |
| 15 |
| 14 |
| 15 |
| EG001 | Placebo | Participants received a single IV infusion of placebo on Study Day 1 | 0 | 3 | 0 | 3 | 2 | 3 |
| Change of bowel habit | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
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| Regurgitation | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA v25.1 | Non-systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
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| Ear infection | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
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| Suspected COVID-19 | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
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| Urinary occult blood positive | Investigations | MedDRA v25.1 | Non-systematic Assessment |
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| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA v25.1 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Non-systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
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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.
| Basophils (10^9/L) > 1.2 ✖ ULN |
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| Eosinophils (10^9/L) > 1.2 ✖ ULN |
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| Prothrombin Time (s) > 1.1 ✖ ULN |
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| Bilirubin (micromol/L) > 1.5 ✖ ULN |
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| Urate (mmol/L) > 1.2 ✖ ULN |
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| pH (Scalar) >8 |
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| URINE Erythrocytes (Scalar) >= 20 |
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| URINE Leukocytes (Scalar) >= 20 |
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| Ketones >= 1 |
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| URINE Hemoglobin >= 1 |
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