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This is a Phase 1, single-center, randomized, double-blind, third-party open (ie, participant blind, investigator blind and sponsor open), placebo controlled study to investigate PK, safety, tolerability, immunogenicity, and PD of PF 06480605 following a single subcutaneous dose of PF-06480605 450 mg and 150 mg (if needed) in Chinese healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 12 participants will be randomly assigned at an allocation ratio of 3:1 to the active treatment 450mg and placebo arms. |
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| Cohort 2 | Experimental | 12 participants will be randomly assigned at an allocation ratio of 3:1 to the active treatment 150mg and placebo arms. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 450mg | Drug | following a single subcutaneous dose of PF-06480605 450 mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) of PF-06480605 | Cmax is the maximum observed plasma concentration. | At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1 |
| Time for Cmax (Tmax) of PF-06480605 | Tmax is the time for Cmax. | At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1 |
| Area Under the Curve From Time 0 to End of Dosing Interval (AUC14day) of PF-06480605 | AUC14day is area under the curve from time 0 to end of dosing interval (Day 14, 336 hours). | At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, and 336 hours post dose on Day 1 |
| Area Under the Plasma Concentration Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06480605 | AUCinf is area under the plasma concentration time profile from time 0 extrapolated to infinite time. | At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1 |
| Terminal Half-life (t1/2) of PF-06480605 | t1/2 is the terminal half-life (time required for the plasma concentration to decline by 50%) | At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 before the end of study (up to follow-up visits). 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. |
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Inclusion Criteria:
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 | 100191 | China |
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| 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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This was a placebo-controlled study of PF-06480605 following 450 mg and 150 mg (if needed) in Chinese healthy adults. Optional 150 mg cohort was not conducted as pharmacokinetic (PK) data of 450mg group did not suggest ethnic difference with previous Western/Japanese studies (by comparing dose-normalized mean exposures/dose-normalized mean concentrations profiles).
A total of 12 Chinese healthy adult participants were enrolled, with 9 assigned to PF-06480605 450mg group and 3 to placebo.
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| ID | Title | Description |
|---|---|---|
| FG000 | PF-06480605 450mg | Participants received a single subcutaneous dose of PF-06480605 450 mg on Day 1. |
| FG001 | Placebo | Participants received matching placebo on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All randomized participants who received a dose of study intervention
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| ID | Title | Description |
|---|---|---|
| BG000 | PF-06480605 450mg | Participants received a single subcutaneous dose of PF-06480605 450 mg on Day 1. |
| BG001 | Placebo | Participants received matching placebo on Day 1. |
| Units | Counts |
|---|---|
| Participants |
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| 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 Observed Concentration (Cmax) of PF-06480605 | Cmax is the maximum observed plasma concentration. | The PK parameter analysis population was defined as all randomized participants who received at least 1 dose of study intervention and for whom at least 1 of the PK parameters of interest was calculated. Data for this outcome measure (OM) was not planned to be collected and analyzed for placebo arm. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1 |
|
Day 1 to Day 114
SAEs and nonserious AEs were recorded on the Case Report Form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24h of awareness. The same event may appear as both an AE and SAE. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.
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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-06480605 450mg | Participants received a single subcutaneous dose of PF-06480605 450 mg on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA v25.0 | 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 | Dec 29, 2020 | Mar 30, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 25, 2022 | Mar 30, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| 150mg |
| Drug |
following a single subcutaneous dose of PF-06480605 150 mg |
|
| Placebo | Drug | following a single subcutaneous dose of placebo |
|
| Day 1 to Day 114 |
| Number of Participants With Change From Baseline in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria | Vital signs abnormalities included: supine diastolic blood pressure (BP) increase and decrease from BL of >=20mmHg or absolute value <50mmHg; systolic BP increase and decrease from BL of >=30mmHg or absolute value <90mmHg; pulse rate <40 or >120bpm. | From Baseline (BL) to Day 114 |
| Number of Participants With Change From Baseline in Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria | ECG assessments included PR, QT, and QTc intervals and QRS complex. ECG abnormalities included PR interval BL >200msec and max >=25% increase from BL, or BL <=200msec and max >=50% increase from BL, or absolute value >=300msec; QRS interval percent change from BL >=50% or absolute value >=140msec, QTcF change from BL >=30msec, or absolute value >450msec. | From BL to Day 114 |
| Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality) | Safety laboratory assessments included clinical chemistry, hematology, urinalysis, and other tests. Abnormality was determined at the investigator's discretion. Laboratory test abnormalities reported by at least 1 participant are reported in this outcome measure. | From BL to Day 114 |
| Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06480605 | AUClast is area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration | At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1 |
| Apparent Volume of Distribution (Vz/F) of PF-06480605 | Vz/F is the apparent volume of distribution, defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. | At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1 |
| Apparent Oral Clearance (CL/F) of PF-06480605 | CL/F is the apparent oral clearance, which is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. | At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1 |
| Number of Participants With Positivie Anti-drug Antibody (ADA) Against PF-06480605 | Summary of ADA incidence by visit is presented. ADA positive was defined as titer >=60. | On Days 1 (prior to dose), 15, 29, 57, 85 and 114 |
| Number of Participants With Neutralizing Antibody (NAb) Against PF-06480605 | Summary of NAb incidence by visit is presented. NAb positive was defined as titer >=5. ADA-positive participants (defined as titer >=60) were analyzed for NAb. | On Days 1 (prior to dose), 15, 29, 57, 85 and 114 |
| Total Soluble Tumor Necrosis Factor Like Ligand 1A (sTL1A) Protein Concentration in Serum | The total sTL1A protein concentration in serum is summarized by time. | On Days 1 (prior to dose), 2, 5, 15, 29, 57, 85 and 114 |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Time for Cmax (Tmax) of PF-06480605 | Tmax is the time for Cmax. | The PK parameter analysis population was defined as all randomized participants who received at least 1 dose of study intervention and for whom at least 1 of the PK parameters of interest was calculated. Data for this OM was not planned to be collected and analyzed for placebo arm. | Posted | Median | Full Range | hour | At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1 |
|
|
|
| Primary | Area Under the Curve From Time 0 to End of Dosing Interval (AUC14day) of PF-06480605 | AUC14day is area under the curve from time 0 to end of dosing interval (Day 14, 336 hours). | The PK parameter analysis population was defined as all randomized participants who received at least 1 dose of study intervention and for whom at least 1 of the PK parameters of interest was calculated. Data for this OM was not planned to be collected and analyzed for placebo arm. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, and 336 hours post dose on Day 1 |
|
|
|
| Primary | Area Under the Plasma Concentration Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06480605 | AUCinf is area under the plasma concentration time profile from time 0 extrapolated to infinite time. | The PK parameter analysis population was defined as all randomized participants who received at least 1 dose of study intervention and for whom at least 1 of the PK parameters of interest was calculated. Data for this OM was not planned to be collected and analyzed for placebo arm. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1 |
|
|
|
| Primary | Terminal Half-life (t1/2) of PF-06480605 | t1/2 is the terminal half-life (time required for the plasma concentration to decline by 50%) | The PK parameter analysis population was defined as all randomized participants who received at least 1 dose of study intervention and for whom at least 1 of the PK parameters of interest was calculated. Data for this OM was not planned to be collected and analyzed for placebo arm. | Posted | Mean | Standard Deviation | hour | At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1 |
|
|
|
| Secondary | 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 before the end of study (up to follow-up visits). 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 set included all randomized participants who received at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Day 1 to Day 114 |
|
|
|
| Secondary | Number of Participants With Change From Baseline in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria | Vital signs abnormalities included: supine diastolic blood pressure (BP) increase and decrease from BL of >=20mmHg or absolute value <50mmHg; systolic BP increase and decrease from BL of >=30mmHg or absolute value <90mmHg; pulse rate <40 or >120bpm. | The safety analysis set included all randomized participants who received at least 1 dose of study intervention. Participants with evaluable vital signs data were analyzed. | Posted | Count of Participants | Participants | From Baseline (BL) to Day 114 |
|
|
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| Secondary | Number of Participants With Change From Baseline in Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria | ECG assessments included PR, QT, and QTc intervals and QRS complex. ECG abnormalities included PR interval BL >200msec and max >=25% increase from BL, or BL <=200msec and max >=50% increase from BL, or absolute value >=300msec; QRS interval percent change from BL >=50% or absolute value >=140msec, QTcF change from BL >=30msec, or absolute value >450msec. | The safety analysis set included all randomized participants who received at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From BL to Day 114 |
|
|
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| Secondary | Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality) | Safety laboratory assessments included clinical chemistry, hematology, urinalysis, and other tests. Abnormality was determined at the investigator's discretion. Laboratory test abnormalities reported by at least 1 participant are reported in this outcome measure. | The safety analysis set included all randomized participants who received at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From BL to Day 114 |
|
|
|
| Secondary | Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06480605 | AUClast is area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration | The PK parameter analysis population was defined as all randomized participants who received at least 1 dose of study intervention and for whom at least 1 of the PK parameters of interest was calculated. Data for this OM was not planned to be collected and analyzed for placebo arm. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1 |
|
|
|
| Secondary | Apparent Volume of Distribution (Vz/F) of PF-06480605 | Vz/F is the apparent volume of distribution, defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. | The PK parameter analysis population was defined as all randomized participants who received at least 1 dose of study intervention and for whom at least 1 of the PK parameters of interest was calculated. Data for this OM was not planned to be collected and analyzed for placebo arm. | Posted | Geometric Mean | Geometric Coefficient of Variation | liter (L) | At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1 |
|
|
|
| Secondary | Apparent Oral Clearance (CL/F) of PF-06480605 | CL/F is the apparent oral clearance, which is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. | The PK parameter analysis population was defined as all randomized participants who received at least 1 dose of study intervention and for whom at least 1 of the PK parameters of interest was calculated. Data for this OM was not planned to be collected and analyzed for placebo arm. | Posted | Geometric Mean | Geometric Coefficient of Variation | liter per hour (L/hr) | At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1 |
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| Secondary | Number of Participants With Positivie Anti-drug Antibody (ADA) Against PF-06480605 | Summary of ADA incidence by visit is presented. ADA positive was defined as titer >=60. | The immunogenicity analysis set included all randomized participants who received at least 1 dose of study intervention with at least 1 post-treatment anti-drug (PF-06480605) antibody determination. Number analyzed = Number of participants with observed ADA results at the specific visit. | Posted | Count of Participants | Participants | On Days 1 (prior to dose), 15, 29, 57, 85 and 114 |
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| Secondary | Number of Participants With Neutralizing Antibody (NAb) Against PF-06480605 | Summary of NAb incidence by visit is presented. NAb positive was defined as titer >=5. ADA-positive participants (defined as titer >=60) were analyzed for NAb. | The immunogenicity analysis set included all randomized participants who received at least 1 dose of study intervention with at least 1 post-treatment anti-drug (PF-06480605) antibody determination. Number of Participants Analyzed = the total number of participants who had ADA-positive results in this study. Number Analyzed = Number of participants who had ADA-positive results at the specific visit. | Posted | Count of Participants | Participants | On Days 1 (prior to dose), 15, 29, 57, 85 and 114 |
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| Secondary | Total Soluble Tumor Necrosis Factor Like Ligand 1A (sTL1A) Protein Concentration in Serum | The total sTL1A protein concentration in serum is summarized by time. | The pharmacodynamic (PD) analysis set included all randomized participants who had at least 1 PD assessment. | Posted | Mean | Standard Deviation | picogram per milliliter (pg/mL) | On Days 1 (prior to dose), 2, 5, 15, 29, 57, 85 and 114 |
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| 0 |
| 9 |
| 0 |
| 9 |
| 7 |
| 9 |
| EG001 | Placebo | Participants received matching placebo on Day 1. | 0 | 3 | 0 | 3 | 3 | 3 |
| Diarrhoea | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Mouth ulceration | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Tongue ulceration | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Injection site reaction | General disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
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| Blood glucose increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
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| White blood cells urine positive | Investigations | MedDRA v25.0 | Non-systematic Assessment |
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| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA v25.0 | 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.
| Monocytes > 1.2 x ULN |
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| Alanine Aminotransferase > 3.0 x ULN |
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| Ketones >=1 |
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| Day 29 |
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| Day 57 |
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| Day 85 |
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| Day 114 |
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| Day 29 |
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| Day 57 |
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| Day 85 |
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| Day 114 |
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| Day 15 |
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| Day 29 |
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