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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-003077-34 | EudraCT Number |
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This is a Phase 1 single and multiple dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06835375 in subjects with seropositive SLE or RA. The design is double-blind, sponsor open and placebo controlled. This study will include two parts: Part A and Part B. Part A will consist of single ascending dose cohorts, Part B of multiple ascending dose cohorts. This study will enroll up to a total of approximately 112 subjects at approximately 10 sites.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A, Cohort 1 | Experimental | Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration |
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| Part A, Cohort 2 | Experimental | Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration. |
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| Part A, Cohort 3 | Experimental | Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration. |
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| Part A, Cohort 4 | Experimental | Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration. |
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| Part A, Cohort 5 | Experimental | Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06835375 | Drug | Intravenous (IV) or subcutaneous (SC) administration. Subjects will receive one or two doses. Doses will be ascending and determined by emerging data. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose-Limiting Toxicity (DLT) | DLT was defined as any of the following events meeting the criteria: (1) >=2 participants within a dose cohort developed Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Grade 3 adverse event considered to be serious in the same organ system or 1 participant developed a CTCAE v4.0 Grade 4 or higher SAE considered related to study drug; (2) 50% or more participants within a dose cohort experienced a CTCAE v4.0 Grade 3 or higher infusion reaction; (3) a confirmed or probable case of Progressive Multifocal Leukoencephalopathy was observed; (4) the mean exposure for the treatment group reached or exceeded the exposure stopping limit of Cav of 261 mg/mL, or, based on the observed data, the group mean Cav of the next planned dose was projected to exceed the exposure stopping limit. Cav = average serum concentration. | From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B) |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Relatedness to study drug was assessed by the investigator. Treatment-emergent were events between first dose of study drug and up to approximately Week 40 that were absent before treatment or that worsened relative to pretreatment state. AEs are classified according to the severity in 3 categories a) mild - AEs does not interfere with participant's usual function b) moderate - AEs interferes to some extent with participant's usual function c) severe - AEs interferes significantly with participant's usual function. | From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B) |
| Number of Participants With All-Causality and Treatment-Related TEAEs | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Relatedness to study drug was assessed by the investigator. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to approximately Week 40 that were absent before treatment or that worsened relative to pretreatment state. |
| Measure | Description | Time Frame |
|---|---|---|
| B Cell Maximum Decrease (%) From Baseline Over Time Following Single and Multiple Doses of PF-06835375 | Blood samples for the assessment of B cell were collected and analyzed by flow cytometry. Baseline was defined as the average of screening and pre-dose measures. | Screening, Day 1, 2, 4, 8, 15, 29, 36 (Part B only), 43, 57, 85, 113, and every 4 weeks until criteria for end of study met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B) |
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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 |
|---|---|---|---|---|---|---|
| Pinnacle Research Group, LLC | Anniston | Alabama | 36201 | United States | ||
| Pinnacle Research Group, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38845046 | Derived | Cohen S, Beebe JS, Chindalore V, Guan S, Hassan-Zahraee M, Saxena M, Xi L, Hyde C, Koride S, Levin R, Lubaczewski S, Salganik M, Sloan A, Stevens E, Peeva E, Vincent MS, Martin DA, Chu M. A Phase 1, randomized, double-blind, placebo-controlled, single- and multiple-dose escalation study to evaluate the safety and pharmacokinetics/pharmacodynamics of PF-06835375, a C-X-C chemokine receptor type 5 directed antibody, in patients with systemic lupus erythematosus or rheumatoid arthritis. Arthritis Res Ther. 2024 Jun 6;26(1):117. doi: 10.1186/s13075-024-03337-2. |
| 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 study included two parts: Part A, consisting of 7 single ascending dose (SAD) cohorts (placebo and PF-06835375 0.03 mg, 0.1 mg, 0.3 mg, 1 mg, 3 mg, 6 mg); and Part B, consisting 6 multiple ascending dose (MAD) cohorts (placebo and PF-06835375 0.3 mg, 1 mg, 3 mg, 6 mg, 10 mg). In Part A (SAD), 32 participants were assigned to treatment, 1 of whom was not treated. In Part B (MAD), 42 participants were screened and treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo IV SAD | Participants received single dose of placebo on Day 1 as an intravenous (IV) infusion. |
| FG001 | PF-06835375 0.03 mg IV SAD | Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Nov 9, 2018 | Jan 10, 2023 |
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| Part A, Cohort 6 |
| Experimental |
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration. |
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| Part A, Cohort 7 | Experimental | Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration. |
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| Part A, Cohort 8 | Experimental | Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration. |
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| Part B, Cohort 1 | Experimental | Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous administration. |
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| Part B, Cohort 2 | Experimental | Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration. |
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| Part B, Cohort 3 | Experimental | Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration. |
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| Part B, Cohort 4 | Experimental | Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration. |
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| Part B, Cohort 5 | Experimental | Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration. |
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| Part B, cohort 6 | Experimental | Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration. |
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| Placebo | Drug | Matching placebo for PF-06835375 IV or SC. Subjects will receive one or two doses. |
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| From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B) |
| Number of Participants With Permanent Discontinuation Due to TEAEs | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between first dose of study drug and up to approximately Week 40 that were absent before treatment or that worsened relative to pretreatment state. | From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B) |
| Number of Participants With Clinically Significant Laboratory Abnormalities in Hematology, Chemistry, and Urinalysis | Hematology included hemoglobin, hematocrit, red blood cell, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet and white blood cell count, total neutrophils, eosinophils, monocytes, basophils and lymphocytes. Chemistry included blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein and creatine kinase. Urinalysis included pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy and creatinine. Clinical significance was judged by the investigator and those met the criteria of AE are listed here. Clinically significant laboratory abnormalities reported for at least 1 participant in the whole study are presented here. Baseline was the last pre-dose measurement (first treatment for MAD cohorts). | From baseline up to end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B) |
| Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria | Criteria for abnormality in vital signs: supine pulse rate <40 beats per minute (bpm) or >120 bpm; standing pulse rate <40 bpm or >120 bpm; sitting systolic blood pressure (BP) <90 mmHg, maximum increase or decrease from baseline of >=30 mmHg; sitting diastolic BP <50 mmHg, maximum increase or decrease from baseline of >=20 mmHg. Baseline was defined as the last pre-dose measurement in Day 1. Only those categories in which at least 1 participant had data were reported. | From baseline up to end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B) |
| Number of Participants With Post-Baseline Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria | ECG abnormalities criteria included: 1) maximum QTc interval (ms): 450<= QTc <480, 480<= QTc <500, and QTc >=500; QTc maximum increase from baseline (ms): 30<= change <60, and change >=60; 2) maximum PR interval (ms): >=300; PR increase from baseline (ms): baseline >200 with 25% increase at maximum, baseline <=200 with 50% increase at maximum; 3) maximum QRS (ms): >=140; QRS increase from baseline (ms) >=50%. QTcF indicates QT interval corrected using the Fridericia's formula. QTcB indicates QT interval corrected using the Bazett's formula. Baseline was defined as the average of the triplicate pre-dose recordings at Day 1. Only those categories in which at least 1 participant had data were reported. | From baseline up to end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B) |
| Number of Participants With All-Causality and Treatment-Related Infections and Infestations | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Relatedness to study drug was assessed by the investigator. The incidence of AEs by system organ class "infections and infestations" was reported here. | From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B) |
| cTfh Cell Depletion Maximum Decrease (%) From Baseline Over Time Following Single and Multiple Doses of PF-06835375 | Blood samples for the assessment of circulating follicular T helper like (cTfh) cell were collected and analyzed by flow cytometry. Baseline was defined as the average of screening and pre-dose measures. | Screening, Day 1, 2, 4, 8, 15, 29, 36 (Part B only), 43, 57, 85, 113, and every 4 weeks until criteria for end of study met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B) |
| Maximum Observed Serum Concentration (Cmax) of PF-06835375 in Part A (SAD) | Cmax is maximum observed serum concentration. Cmax for PF-06835375 was observed directly from data. | Day 1 (pre-dose, 2, 4, 6, 8, 12 hours post dose), 2, 4, 8, 15, 29, 43, 57, 85, 113 and 141 for Day 1 PK estimates |
| Time to Reach Cmax (Tmax) of PF-06835375 in Part A (SAD) | Tmax is the time for Cmax. Tmax for PF-06835375 was observed directly from data as time of first occurrence. | Day 1 (pre-dose, 2, 4, 6, 8, 12 hours post dose), 2, 4, 8, 15, 29, 43, 57, 85, 113 and 141 for Day 1 PK estimates |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-06835375 in Part A (SAD) | AUCinf is the area under the serum concentration-time profile from time zero extrapolated to infinite time. | Day 1 (pre-dose, 2, 4, 6, 8, 12 hours post dose), 2, 4, 8, 15, 29, 43, 57, 85, 113 and 141 for Day 1 PK estimates |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06835375 in Part A (SAD) | AUClast is the area under the curve from time zero to last quantifiable concentration. AUClast for PF-06835375 was determined using linear/log trapezoidal method. | Day 1 (pre-dose, 2, 4, 6, 8, 12 hours post dose), 2, 4, 8, 15, 29, 43, 57, 85, 113 and 141 for Day 1 PK estimates |
| Cmax of PF-06835375 Following First Dose and Multiple Doses in Part B (MAD) | Cmax is maximum observed serum concentration. Cmax for PF-06835375 was observed directly from data. There were less than 3 quantifiable concentrations for participants in PF-06835375 0.3 mg SC MAD cohort, therefore the serum PK parameters were not calculated. | Day 1 (pre-dose, 2, 4, 6, 8, 12 hours post dose), 2, 4, 8 and 15 for Day 1 PK estimates; Day 29 (pre-dose, 2, 4, 6, 8, hours post dose), 36, 43, 57, 85 and 113 for Day 29 PK estimates |
| Tmax of PF-06835375 Following First Dose and Multiple Doses in Part B (MAD) | Tmax is the time for Cmax. Tmax for PF-06835375 was observed directly from data as time of first occurrence. There were less than 3 quantifiable concentrations for participants in PF-06835375 0.3 mg SC MAD cohort, therefore the serum PK parameters were not calculated. | Day 1 (pre-dose, 2, 4, 6, 8, 12 hours post dose), 2, 4, 8 and 15 for Day 1 PK estimates; Day 29 (pre-dose, 2, 4, 6, 8, hours post dose), 36, 43, 57, 85 and 113 for Day 29 PK estimates |
| Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06835375 Following First Dose and Multiple Doses in Part B (MAD) | AUCtau is area under the serum concentration-time profile from time 0 to time tau, the dosing interval, where tau= 28 days. AUCtau for PF-06835375 was determined using linear/log trapezoidal method. There were less than 3 quantifiable concentrations for participants in PF-06835375 0.3 mg SC MAD cohort, therefore the serum PK parameters were not calculated. | Day 1 (pre-dose, 2, 4, 6, 8, 12 hours post dose), 2, 4, 8 and 15 for Day 1 PK estimates; Day 29 (pre-dose, 2, 4, 6, 8, hours post dose), 36, 43, 57, 85 and 113 for Day 29 PK estimates |
| AUClast of PF-06835375 Following Multiple Doses in Part B (MAD) | AUClast is the area under the curve from time zero to last quantifiable concentration. AUClast for PF-06835375 was determined using linear/log trapezoidal method. There were less than 3 quantifiable concentrations for participants in PF-06835375 0.3 mg SC MAD cohort, therefore the serum PK parameters were not calculated. | Day 29 (pre-dose, 2, 4, 6, 8, hours post dose), 36, 43, 57, 85 and 113 for Day 29 PK estimates |
| Minimum Observed Serum Trough Concentration (Cmin) of PF-06835375 Following Multiple Doses in Part B (MAD) | Cmin is minimum observed serum trough concentration. Cmin was observed directly from data. There were less than 3 quantifiable concentrations for participants in PF-06835375 0.3 mg SC MAD cohort, therefore the serum PK parameters were not calculated. | Day 29 (pre-dose, 2, 4, 6, 8, hours post dose), 36, 43, 57, 85 and 113 for Day 29 PK estimates |
| Observed Accumulation Ratio (Rac) of PF-06835375 Following Multiple Doses in Part B (MAD) | Rac is observed accumulation ratio. Rac = Day 29 AUCtau / Day 1 AUCtau. There were less than 3 quantifiable concentrations for participants in PF-06835375 0.3 mg SC MAD cohort, therefore the serum PK parameters were not calculated. | Day 1 (pre-dose, 2, 4, 6, 8, 12 hours post dose), 2, 4, 8 and 15 for Day 1 PK estimates; Day 29 (pre-dose, 2, 4, 6, 8, hours post dose), 36, 43, 57, 85 and 113 for Day 29 PK estimates |
| Peak-to-trough Fluctuation (PTF) of PF-06835375 Following Multiple Doses in Part B (MAD) | PTF is peak-to-trough fluctuation at steady state. PTF = (Cmax-Cmin)/Cav. Cav is average serum concentration. There were less than 3 quantifiable concentrations for participants in PF-06835375 0.3 mg SC MAD cohort, therefore the serum PK parameters were not calculated. | Day 29 (pre-dose, 2, 4, 6, 8, hours post dose), 36, 43, 57, 85 and 113 for Day 29 PK estimates |
| Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibody (NAb) Against PF-06835375 | To evaluate the immunogenicity as measured by presence of ADA and NAb in participants treated with PF-06835375. | Day 1, 15, 29, 43, 57, 85, 113, and every 4 weeks until criteria for end of study met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B) |
| Anniston |
| Alabama |
| 36207 |
| United States |
| Wallace Rheumatic Studies Center | Beverly Hills | California | 90211 | United States |
| Prive aftercare | Los Angeles | California | 90048 | United States |
| Clinical Research of West Florida, Inc. | Clearwater | Florida | 33765 | United States |
| Private Practice of Robert W. Levin, MD | Clearwater | Florida | 33765 | United States |
| Avail Clinical Research | DeLand | Florida | 32720 | United States |
| Omega Research Maitland, LLC | Orlando | Florida | 32808 | United States |
| Larkin Hospital | South Miami | Florida | 33143 | United States |
| Qps Mra, Llc | South Miami | Florida | 33143 | United States |
| Qps-Mra, Llc | South Miami | Florida | 33143 | United States |
| PAREXEL International - EPCU Baltimore | Baltimore | Maryland | 21225 | United States |
| Rheumatology Express | Catonsville | Maryland | 21228 | United States |
| Carolina Phase 1 Research, LLC | Raleigh | North Carolina | 27612 | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| Metroplex Clinical Research Center | Dallas | Texas | 75231 | United States |
| MPP Infusion Centers | Dallas | Texas | 75231 | United States |
| FG002 | PF-06835375 0.1 mg IV SAD | Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion. |
| FG003 | PF-06835375 0.3 mg IV SAD | Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion. |
| FG004 | PF-06835375 1 mg IV SAD | Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion. |
| FG005 | PF-06835375 3 mg IV SAD | Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion. |
| FG006 | PF-06835375 6 mg IV SAD | Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion. |
| FG007 | Placebo SC MAD | Participants received two doses of placebo subcutaneously (SC) with first dose on Day 1 and the repeated dose on Day 29. |
| FG008 | PF-06835375 0.3 mg SC MAD | Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| FG009 | PF-06835375 1 mg SC MAD | Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| FG010 | PF-06835375 3 mg SC MAD | Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| FG011 | PF-06835375 6 mg SC MAD | Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| FG012 | PF-06835375 10 mg SC MAD | Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| COMPLETED |
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| NOT COMPLETED |
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Baseline analysis population included all enrolled participants who received at least one dose of study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo IV SAD | Participants received single dose of placebo on Day 1 as an intravenous (IV) infusion. |
| BG001 | PF-06835375 0.03 mg IV SAD | Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion. |
| BG002 | PF-06835375 0.1 mg IV SAD | Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion. |
| BG003 | PF-06835375 0.3 mg IV SAD | Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion. |
| BG004 | PF-06835375 1 mg IV SAD | Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion. |
| BG005 | PF-06835375 3 mg IV SAD | Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion. |
| BG006 | PF-06835375 6 mg IV SAD | Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion. |
| BG007 | Placebo SC MAD | Participants received two doses of placebo subcutaneously (SC) with first dose on Day 1 and the repeated dose on Day 29. |
| BG008 | PF-06835375 0.3 mg SC MAD | Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| BG009 | PF-06835375 1 mg SC MAD | Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| BG010 | PF-06835375 3 mg SC MAD | Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| BG011 | PF-06835375 6 mg SC MAD | Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| BG012 | PF-06835375 10 mg SC MAD | Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| BG013 | Total | Total of all reporting groups |
| 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 | Mean | Standard Deviation | Years |
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| Age, Customized | Number | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Participants With Dose-Limiting Toxicity (DLT) | DLT was defined as any of the following events meeting the criteria: (1) >=2 participants within a dose cohort developed Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Grade 3 adverse event considered to be serious in the same organ system or 1 participant developed a CTCAE v4.0 Grade 4 or higher SAE considered related to study drug; (2) 50% or more participants within a dose cohort experienced a CTCAE v4.0 Grade 3 or higher infusion reaction; (3) a confirmed or probable case of Progressive Multifocal Leukoencephalopathy was observed; (4) the mean exposure for the treatment group reached or exceeded the exposure stopping limit of Cav of 261 mg/mL, or, based on the observed data, the group mean Cav of the next planned dose was projected to exceed the exposure stopping limit. Cav = average serum concentration. | All participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B) |
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| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Relatedness to study drug was assessed by the investigator. Treatment-emergent were events between first dose of study drug and up to approximately Week 40 that were absent before treatment or that worsened relative to pretreatment state. AEs are classified according to the severity in 3 categories a) mild - AEs does not interfere with participant's usual function b) moderate - AEs interferes to some extent with participant's usual function c) severe - AEs interferes significantly with participant's usual function. | All participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B) |
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| Primary | Number of Participants With All-Causality and Treatment-Related TEAEs | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Relatedness to study drug was assessed by the investigator. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to approximately Week 40 that were absent before treatment or that worsened relative to pretreatment state. | All participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B) |
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| Primary | Number of Participants With Permanent Discontinuation Due to TEAEs | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between first dose of study drug and up to approximately Week 40 that were absent before treatment or that worsened relative to pretreatment state. | All participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B) |
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| Primary | Number of Participants With Clinically Significant Laboratory Abnormalities in Hematology, Chemistry, and Urinalysis | Hematology included hemoglobin, hematocrit, red blood cell, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet and white blood cell count, total neutrophils, eosinophils, monocytes, basophils and lymphocytes. Chemistry included blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein and creatine kinase. Urinalysis included pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy and creatinine. Clinical significance was judged by the investigator and those met the criteria of AE are listed here. Clinically significant laboratory abnormalities reported for at least 1 participant in the whole study are presented here. Baseline was the last pre-dose measurement (first treatment for MAD cohorts). | All participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | From baseline up to end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B) |
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| Primary | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria | Criteria for abnormality in vital signs: supine pulse rate <40 beats per minute (bpm) or >120 bpm; standing pulse rate <40 bpm or >120 bpm; sitting systolic blood pressure (BP) <90 mmHg, maximum increase or decrease from baseline of >=30 mmHg; sitting diastolic BP <50 mmHg, maximum increase or decrease from baseline of >=20 mmHg. Baseline was defined as the last pre-dose measurement in Day 1. Only those categories in which at least 1 participant had data were reported. | All participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | From baseline up to end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B) |
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| Primary | Number of Participants With Post-Baseline Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria | ECG abnormalities criteria included: 1) maximum QTc interval (ms): 450<= QTc <480, 480<= QTc <500, and QTc >=500; QTc maximum increase from baseline (ms): 30<= change <60, and change >=60; 2) maximum PR interval (ms): >=300; PR increase from baseline (ms): baseline >200 with 25% increase at maximum, baseline <=200 with 50% increase at maximum; 3) maximum QRS (ms): >=140; QRS increase from baseline (ms) >=50%. QTcF indicates QT interval corrected using the Fridericia's formula. QTcB indicates QT interval corrected using the Bazett's formula. Baseline was defined as the average of the triplicate pre-dose recordings at Day 1. Only those categories in which at least 1 participant had data were reported. | All participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | From baseline up to end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B) |
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| Primary | Number of Participants With All-Causality and Treatment-Related Infections and Infestations | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Relatedness to study drug was assessed by the investigator. The incidence of AEs by system organ class "infections and infestations" was reported here. | All participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B) |
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| Secondary | B Cell Maximum Decrease (%) From Baseline Over Time Following Single and Multiple Doses of PF-06835375 | Blood samples for the assessment of B cell were collected and analyzed by flow cytometry. Baseline was defined as the average of screening and pre-dose measures. | All enrolled participants who received at least 1 dose of study treatment and had at least 1 pharmacodynamic measurement. | Posted | Geometric Mean | Geometric Coefficient of Variation | Percentage of decrease from baseline | Screening, Day 1, 2, 4, 8, 15, 29, 36 (Part B only), 43, 57, 85, 113, and every 4 weeks until criteria for end of study met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B) |
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| Secondary | cTfh Cell Depletion Maximum Decrease (%) From Baseline Over Time Following Single and Multiple Doses of PF-06835375 | Blood samples for the assessment of circulating follicular T helper like (cTfh) cell were collected and analyzed by flow cytometry. Baseline was defined as the average of screening and pre-dose measures. | All enrolled participants who received at least 1 dose of study treatment and had at least 1 pharmacodynamic measurement. | Posted | Geometric Mean | Geometric Coefficient of Variation | Percentage of decrease from baseline | Screening, Day 1, 2, 4, 8, 15, 29, 36 (Part B only), 43, 57, 85, 113, and every 4 weeks until criteria for end of study met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B) |
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| Secondary | Maximum Observed Serum Concentration (Cmax) of PF-06835375 in Part A (SAD) | Cmax is maximum observed serum concentration. Cmax for PF-06835375 was observed directly from data. | All enrolled participants treated who had at least 1 of the PK parameters of interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram/milliliter (ng/mL) | Day 1 (pre-dose, 2, 4, 6, 8, 12 hours post dose), 2, 4, 8, 15, 29, 43, 57, 85, 113 and 141 for Day 1 PK estimates |
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| Secondary | Time to Reach Cmax (Tmax) of PF-06835375 in Part A (SAD) | Tmax is the time for Cmax. Tmax for PF-06835375 was observed directly from data as time of first occurrence. | All enrolled participants treated who had at least 1 of the PK parameters of interest. | Posted | Median | Full Range | hour (hr) | Day 1 (pre-dose, 2, 4, 6, 8, 12 hours post dose), 2, 4, 8, 15, 29, 43, 57, 85, 113 and 141 for Day 1 PK estimates |
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| Secondary | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-06835375 in Part A (SAD) | AUCinf is the area under the serum concentration-time profile from time zero extrapolated to infinite time. | All enrolled participants treated who had at least 1 of the PK parameters of interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour/milliliter (ng*hr/mL) | Day 1 (pre-dose, 2, 4, 6, 8, 12 hours post dose), 2, 4, 8, 15, 29, 43, 57, 85, 113 and 141 for Day 1 PK estimates |
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| Secondary | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06835375 in Part A (SAD) | AUClast is the area under the curve from time zero to last quantifiable concentration. AUClast for PF-06835375 was determined using linear/log trapezoidal method. | All enrolled participants treated who had at least 1 of the PK parameters of interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Day 1 (pre-dose, 2, 4, 6, 8, 12 hours post dose), 2, 4, 8, 15, 29, 43, 57, 85, 113 and 141 for Day 1 PK estimates |
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| Secondary | Cmax of PF-06835375 Following First Dose and Multiple Doses in Part B (MAD) | Cmax is maximum observed serum concentration. Cmax for PF-06835375 was observed directly from data. There were less than 3 quantifiable concentrations for participants in PF-06835375 0.3 mg SC MAD cohort, therefore the serum PK parameters were not calculated. | All enrolled participants treated who had at least 1 of the PK parameters of interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 1 (pre-dose, 2, 4, 6, 8, 12 hours post dose), 2, 4, 8 and 15 for Day 1 PK estimates; Day 29 (pre-dose, 2, 4, 6, 8, hours post dose), 36, 43, 57, 85 and 113 for Day 29 PK estimates |
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| Secondary | Tmax of PF-06835375 Following First Dose and Multiple Doses in Part B (MAD) | Tmax is the time for Cmax. Tmax for PF-06835375 was observed directly from data as time of first occurrence. There were less than 3 quantifiable concentrations for participants in PF-06835375 0.3 mg SC MAD cohort, therefore the serum PK parameters were not calculated. | All enrolled participants treated who had at least 1 of the PK parameters of interest. | Posted | Median | Full Range | hr | Day 1 (pre-dose, 2, 4, 6, 8, 12 hours post dose), 2, 4, 8 and 15 for Day 1 PK estimates; Day 29 (pre-dose, 2, 4, 6, 8, hours post dose), 36, 43, 57, 85 and 113 for Day 29 PK estimates |
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| Secondary | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06835375 Following First Dose and Multiple Doses in Part B (MAD) | AUCtau is area under the serum concentration-time profile from time 0 to time tau, the dosing interval, where tau= 28 days. AUCtau for PF-06835375 was determined using linear/log trapezoidal method. There were less than 3 quantifiable concentrations for participants in PF-06835375 0.3 mg SC MAD cohort, therefore the serum PK parameters were not calculated. | All enrolled participants treated who had at least 1 of the PK parameters of interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Day 1 (pre-dose, 2, 4, 6, 8, 12 hours post dose), 2, 4, 8 and 15 for Day 1 PK estimates; Day 29 (pre-dose, 2, 4, 6, 8, hours post dose), 36, 43, 57, 85 and 113 for Day 29 PK estimates |
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| Secondary | AUClast of PF-06835375 Following Multiple Doses in Part B (MAD) | AUClast is the area under the curve from time zero to last quantifiable concentration. AUClast for PF-06835375 was determined using linear/log trapezoidal method. There were less than 3 quantifiable concentrations for participants in PF-06835375 0.3 mg SC MAD cohort, therefore the serum PK parameters were not calculated. | All enrolled participants treated who had at least 1 of the PK parameters of interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Day 29 (pre-dose, 2, 4, 6, 8, hours post dose), 36, 43, 57, 85 and 113 for Day 29 PK estimates |
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| Secondary | Minimum Observed Serum Trough Concentration (Cmin) of PF-06835375 Following Multiple Doses in Part B (MAD) | Cmin is minimum observed serum trough concentration. Cmin was observed directly from data. There were less than 3 quantifiable concentrations for participants in PF-06835375 0.3 mg SC MAD cohort, therefore the serum PK parameters were not calculated. | All enrolled participants treated who had at least 1 of the PK parameters of interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 29 (pre-dose, 2, 4, 6, 8, hours post dose), 36, 43, 57, 85 and 113 for Day 29 PK estimates |
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| Secondary | Observed Accumulation Ratio (Rac) of PF-06835375 Following Multiple Doses in Part B (MAD) | Rac is observed accumulation ratio. Rac = Day 29 AUCtau / Day 1 AUCtau. There were less than 3 quantifiable concentrations for participants in PF-06835375 0.3 mg SC MAD cohort, therefore the serum PK parameters were not calculated. | All enrolled participants treated who had at least 1 of the PK parameters of interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio | Day 1 (pre-dose, 2, 4, 6, 8, 12 hours post dose), 2, 4, 8 and 15 for Day 1 PK estimates; Day 29 (pre-dose, 2, 4, 6, 8, hours post dose), 36, 43, 57, 85 and 113 for Day 29 PK estimates |
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| Secondary | Peak-to-trough Fluctuation (PTF) of PF-06835375 Following Multiple Doses in Part B (MAD) | PTF is peak-to-trough fluctuation at steady state. PTF = (Cmax-Cmin)/Cav. Cav is average serum concentration. There were less than 3 quantifiable concentrations for participants in PF-06835375 0.3 mg SC MAD cohort, therefore the serum PK parameters were not calculated. | All enrolled participants treated who had at least 1 of the PK parameters of interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio | Day 29 (pre-dose, 2, 4, 6, 8, hours post dose), 36, 43, 57, 85 and 113 for Day 29 PK estimates |
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| Secondary | Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibody (NAb) Against PF-06835375 | To evaluate the immunogenicity as measured by presence of ADA and NAb in participants treated with PF-06835375. | All enrolled participants who received at least 1 dose of study treatment and had at least 1 pharmacodynamic measurement. | Posted | Count of Participants | Participants | Day 1, 15, 29, 43, 57, 85, 113, and every 4 weeks until criteria for end of study met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B) |
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From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo IV SAD | Participants received single dose of placebo on Day 1 as an intravenous (IV) infusion. | 0 | 8 | 1 | 8 | 8 | 8 |
| EG001 | PF-06835375 0.03 mg IV SAD | Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion. | 0 | 3 | 1 | 3 | 3 | 3 |
| EG002 | PF-06835375 0.1 mg IV SAD | Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG003 | PF-06835375 0.3 mg IV SAD | Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion. | 0 | 3 | 1 | 3 | 2 | 3 |
| EG004 | PF-06835375 1 mg IV SAD | Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG005 | PF-06835375 3 mg IV SAD | Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion. | 0 | 6 | 0 | 6 | 6 | 6 |
| EG006 | PF-06835375 6 mg IV SAD | Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion. | 0 | 5 | 0 | 5 | 5 | 5 |
| EG007 | Placebo SC MAD | Participants received two doses of placebo subcutaneously (SC) with first dose on Day 1 and the repeated dose on Day 29. | 0 | 11 | 0 | 11 | 9 | 11 |
| EG008 | PF-06835375 0.3 mg SC MAD | Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29. | 0 | 6 | 0 | 6 | 4 | 6 |
| EG009 | PF-06835375 1 mg SC MAD | Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29. | 0 | 6 | 0 | 6 | 4 | 6 |
| EG010 | PF-06835375 3 mg SC MAD | Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29. | 0 | 7 | 0 | 7 | 5 | 7 |
| EG011 | PF-06835375 6 mg SC MAD | Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29. | 0 | 6 | 0 | 6 | 4 | 6 |
| EG012 | PF-06835375 10 mg SC MAD | Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29. | 0 | 6 | 0 | 6 | 6 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Lip swelling | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Injection site scab | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Electrocardiogram T wave amplitude decreased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Skin burning sensation | Skin and subcutaneous tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hyperparathyroidism secondary | Endocrine disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Keratitis | Eye disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Anal haemorrhage | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Gastrointestinal inflammation | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Oesophageal stenosis | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Mass | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Swelling | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Tenderness | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Vaccination site erythema | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Vaccination site induration | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Vaccination site nodule | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Vaccination site pain | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Vaccination site swelling | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Vaccination site warmth | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Gallbladder disorder | Hepatobiliary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Allergy to vaccine | Immune system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Bacterial vulvovaginitis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Gastrointestinal viral infection | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Vaccination complication | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Vitamin B12 deficiency | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Device malfunction | Product Issues | MedDRA v24.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hallucination, visual | Psychiatric disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hypercalciuria | Renal and urinary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Stag horn calculus | Renal and urinary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Tooth extraction | Surgical and medical procedures | MedDRA v24.1 | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA v24.1 | Non-systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 14, 2022 | Jan 10, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| 18-44 |
|
| 45-64 |
|
| >=65 |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| OG009 | PF-06835375 1 mg SC MAD | Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| OG010 | PF-06835375 3 mg SC MAD | Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| OG011 | PF-06835375 6 mg SC MAD | Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| OG012 | PF-06835375 10 mg SC MAD | Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| OG002 | PF-06835375 0.1 mg IV SAD | Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion. |
| OG003 | PF-06835375 0.3 mg IV SAD | Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion. |
| OG004 | PF-06835375 1 mg IV SAD | Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion. |
| OG005 | PF-06835375 3 mg IV SAD | Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion. |
| OG006 | PF-06835375 6 mg IV SAD | Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion. |
| OG007 | Placebo SC MAD | Participants received two doses of placebo subcutaneously (SC) with first dose on Day 1 and the repeated dose on Day 29. |
| OG008 | PF-06835375 0.3 mg SC MAD | Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| OG009 | PF-06835375 1 mg SC MAD | Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| OG010 | PF-06835375 3 mg SC MAD | Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| OG011 | PF-06835375 6 mg SC MAD | Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| OG012 | PF-06835375 10 mg SC MAD | Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
|
|
| OG002 | PF-06835375 0.1 mg IV SAD | Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion. |
| OG003 | PF-06835375 0.3 mg IV SAD | Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion. |
| OG004 | PF-06835375 1 mg IV SAD | Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion. |
| OG005 | PF-06835375 3 mg IV SAD | Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion. |
| OG006 | PF-06835375 6 mg IV SAD | Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion. |
| OG007 | Placebo SC MAD | Participants received two doses of placebo subcutaneously (SC) with first dose on Day 1 and the repeated dose on Day 29. |
| OG008 | PF-06835375 0.3 mg SC MAD | Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| OG009 | PF-06835375 1 mg SC MAD | Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| OG010 | PF-06835375 3 mg SC MAD | Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| OG011 | PF-06835375 6 mg SC MAD | Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| OG012 | PF-06835375 10 mg SC MAD | Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
|
|
| PF-06835375 0.3 mg IV SAD |
Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion. |
| OG004 | PF-06835375 1 mg IV SAD | Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion. |
| OG005 | PF-06835375 3 mg IV SAD | Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion. |
| OG006 | PF-06835375 6 mg IV SAD | Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion. |
| OG007 | Placebo SC MAD | Participants received two doses of placebo subcutaneously (SC) with first dose on Day 1 and the repeated dose on Day 29. |
| OG008 | PF-06835375 0.3 mg SC MAD | Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| OG009 | PF-06835375 1 mg SC MAD | Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| OG010 | PF-06835375 3 mg SC MAD | Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| OG011 | PF-06835375 6 mg SC MAD | Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| OG012 | PF-06835375 10 mg SC MAD | Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
|
|
Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion.
| OG002 | PF-06835375 0.1 mg IV SAD | Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion. |
| OG003 | PF-06835375 0.3 mg IV SAD | Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion. |
| OG004 | PF-06835375 1 mg IV SAD | Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion. |
| OG005 | PF-06835375 3 mg IV SAD | Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion. |
| OG006 | PF-06835375 6 mg IV SAD | Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion. |
| OG007 | Placebo SC MAD | Participants received two doses of placebo subcutaneously (SC) with first dose on Day 1 and the repeated dose on Day 29. |
| OG008 | PF-06835375 0.3 mg SC MAD | Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| OG009 | PF-06835375 1 mg SC MAD | Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| OG010 | PF-06835375 3 mg SC MAD | Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| OG011 | PF-06835375 6 mg SC MAD | Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| OG012 | PF-06835375 10 mg SC MAD | Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
|
|
| OG003 | PF-06835375 0.3 mg IV SAD | Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion. |
| OG004 | PF-06835375 1 mg IV SAD | Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion. |
| OG005 | PF-06835375 3 mg IV SAD | Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion. |
| OG006 | PF-06835375 6 mg IV SAD | Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion. |
| OG007 | Placebo SC MAD | Participants received two doses of placebo subcutaneously (SC) with first dose on Day 1 and the repeated dose on Day 29. |
| OG008 | PF-06835375 0.3 mg SC MAD | Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| OG009 | PF-06835375 1 mg SC MAD | Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| OG010 | PF-06835375 3 mg SC MAD | Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| OG011 | PF-06835375 6 mg SC MAD | Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| OG012 | PF-06835375 10 mg SC MAD | Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
|
|
| PF-06835375 0.1 mg IV SAD |
Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion. |
| OG003 | PF-06835375 0.3 mg IV SAD | Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion. |
| OG004 | PF-06835375 1 mg IV SAD | Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion. |
| OG005 | PF-06835375 3 mg IV SAD | Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion. |
| OG006 | PF-06835375 6 mg IV SAD | Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion. |
| OG007 | Placebo SC MAD | Participants received two doses of placebo subcutaneously (SC) with first dose on Day 1 and the repeated dose on Day 29. |
| OG008 | PF-06835375 0.3 mg SC MAD | Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| OG009 | PF-06835375 1 mg SC MAD | Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| OG010 | PF-06835375 3 mg SC MAD | Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| OG011 | PF-06835375 6 mg SC MAD | Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| OG012 | PF-06835375 10 mg SC MAD | Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
|
|
| OG003 | PF-06835375 0.3 mg IV SAD | Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion. |
| OG004 | PF-06835375 1 mg IV SAD | Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion. |
| OG005 | PF-06835375 3 mg IV SAD | Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion. |
| OG006 | PF-06835375 6 mg IV SAD | Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion. |
| OG007 | Placebo SC MAD | Participants received two doses of placebo subcutaneously (SC) with first dose on Day 1 and the repeated dose on Day 29. |
| OG008 | PF-06835375 0.3 mg SC MAD | Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| OG009 | PF-06835375 1 mg SC MAD | Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| OG010 | PF-06835375 3 mg SC MAD | Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| OG011 | PF-06835375 6 mg SC MAD | Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| OG012 | PF-06835375 10 mg SC MAD | Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
|
|
| PF-06835375 0.3 mg IV SAD |
Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion. |
| OG004 | PF-06835375 1 mg IV SAD | Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion. |
| OG005 | PF-06835375 3 mg IV SAD | Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion. |
| OG006 | PF-06835375 6 mg IV SAD | Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion. |
| OG007 | Placebo SC MAD | Participants received two doses of placebo subcutaneously (SC) with first dose on Day 1 and the repeated dose on Day 29. |
| OG008 | PF-06835375 0.3 mg SC MAD | Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| OG009 | PF-06835375 1 mg SC MAD | Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| OG010 | PF-06835375 3 mg SC MAD | Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| OG011 | PF-06835375 6 mg SC MAD | Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| OG012 | PF-06835375 10 mg SC MAD | Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
|
|
| OG003 |
| PF-06835375 0.3 mg IV SAD |
Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion. |
| OG004 | PF-06835375 1 mg IV SAD | Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion. |
| OG005 | PF-06835375 3 mg IV SAD | Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion. |
| OG006 | PF-06835375 6 mg IV SAD | Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion. |
| OG007 | Placebo SC MAD | Participants received two doses of placebo subcutaneously (SC) with first dose on Day 1 and the repeated dose on Day 29. |
| OG008 | PF-06835375 0.3 mg SC MAD | Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| OG009 | PF-06835375 1 mg SC MAD | Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| OG010 | PF-06835375 3 mg SC MAD | Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| OG011 | PF-06835375 6 mg SC MAD | Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| OG012 | PF-06835375 10 mg SC MAD | Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
|
|
| OG004 | PF-06835375 3 mg IV SAD | Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion. |
| OG005 | PF-06835375 6 mg IV SAD | Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion. |
|
|
| OG004 | PF-06835375 3 mg IV SAD | Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion. |
| OG005 | PF-06835375 6 mg IV SAD | Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion. |
|
|
| OG004 | PF-06835375 3 mg IV SAD | Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion. |
| OG005 | PF-06835375 6 mg IV SAD | Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion. |
|
|
Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion.
| OG004 | PF-06835375 3 mg IV SAD | Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion. |
| OG005 | PF-06835375 6 mg IV SAD | Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion. |
|
|
| OG003 |
| PF-06835375 10 mg SC MAD |
Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
|
|
| OG003 |
| PF-06835375 10 mg SC MAD |
Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
|
|
| OG003 | PF-06835375 10 mg SC MAD | Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
|
|
| OG003 |
| PF-06835375 10 mg SC MAD |
Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
|
|
| PF-06835375 10 mg SC MAD |
Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
|
|
| OG003 |
| PF-06835375 10 mg SC MAD |
Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
|
|
| PF-06835375 10 mg SC MAD |
Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
|
|
Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion.
| OG004 | PF-06835375 3 mg IV SAD | Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion. |
| OG005 | PF-06835375 6 mg IV SAD | Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion. |
| OG006 | PF-06835375 0.3 mg SC MAD | Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| OG007 | PF-06835375 1 mg SC MAD | Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| OG008 | PF-06835375 3 mg SC MAD | Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| OG009 | PF-06835375 6 mg SC MAD | Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
| OG010 | PF-06835375 10 mg SC MAD | Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29. |
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|