A Phase 1 interventional study of PF-06835375 and Placebo in Systemic Lupus Erythematosus and Rheumatoid Arthritis, sponsored by Pfizer. Completed at 17 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-10-30.
Sponsored by Pfizer · Phase 1, Interventional, and Basic science
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Among 477 studies in Lupus Erythematosus, Systemic with a site in United States — 87 open to participants now, 127 under way, 28 of them phase 3. Lupus Erythematosus, Systemic · United States.
Among the 477 studies in Lupus Erythematosus, Systemic with a site in United States, this one is the 200th largest by enrollment of the 407 interventional ones that give a count, is one of 23 that started in 2017, is one of 104 in phase 1, and was the 253rd registered.
1,210 studies on the registry are indexed under Lupus Erythematosus, Systemic; 406 are open to participants now.
Browse Lupus Erythematosus, Systemic studies →87 of the 477 studies in Lupus Erythematosus, Systemic with a site in United States are open now. Recruiting first, the newest first:
National Human Genome Research Institute (NHGRI) · Sites in United States, Peru
Ages 18–115
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · Sites in United States
Ages 9–85 · Healthy volunteers
EMD Serono Research & Development Institute, Inc. · Sites in United States
Ages 18–76
Fate Therapeutics · Sites in United States
Ages 18–70
NYU Langone Health · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 284 Lupus Erythematosus, Systemic studies recruiting now, 93 (33%) set no upper age limit and 161 (57%) stop at 75 or younger; 54 take children under 18; 33 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
477 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 130 · Phase 2 151 · Phase 3 75 · Phase 4 17
First in 1986; this study’s year is marked. 23 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 74 is above the median of 52 across 878 interventional studies indexed under Lupus Erythematosus, Systemic.
Median enrollment 70 across the 407 interventional studies, 223 across the 67 observational. Of the 309 that completed or were terminated, 147 (48%) have results posted.
This tab as a report to print or save as PDF → With an account.
264 of 477 have an industry lead sponsor. The 10 most frequent:
Pfizer is the lead sponsor of 3,337 studies on the registry; 150 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 392 (65%) have results posted.
Pfizer has 9 studies filed under Lupus Erythematosus, Systemic — fewer than ten, so there is no comparison to draw.
33 of the studies in Lupus Erythematosus, Systemic with a site in United States that are under way reach primary completion within a year, 7 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05672576Phase 3Viatris Innovation GmbHA Research Study to Evaluate the Efficacy and Safety of Cenerimod in Subjects Suffering From Systemic Lupus Erythematosus | 2026-12-31 |
| NCT05138133Phase 3AstraZenecaPhase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis | 2027-02-23 |
| NCT05843643Phase 3AbbVieProgram to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus | 2027-03 |
| NCT05639114Phase 3Novartis PharmaceuticalsPhase 3 Study to Evaluate Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 1) | 2027-03-26 |
| NCT05648500Phase 3Viatris Innovation GmbHA Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus | 2027-03-31 |
Add all 33 to your calendar (.ics) → With an account.
Among the 477 studies in Lupus Erythematosus, Systemic with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration
Drug: PF-06835375 · Drug: Placebo
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
Drug: PF-06835375 · Drug: Placebo
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
Drug: PF-06835375 · Drug: Placebo
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
Drug: PF-06835375 · Drug: Placebo
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
Drug: PF-06835375 · Drug: Placebo
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
Drug: PF-06835375 · Drug: Placebo
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
Drug: PF-06835375 · Drug: Placebo
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
Drug: PF-06835375 · Drug: Placebo
Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous administration.
Drug: PF-06835375 · Drug: Placebo
Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.
Drug: PF-06835375 · Drug: Placebo
Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.
Drug: PF-06835375 · Drug: Placebo
Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.
Drug: PF-06835375 · Drug: Placebo
Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.
Drug: PF-06835375 · Drug: Placebo
Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.
Drug: PF-06835375 · Drug: Placebo
Intravenous (IV) or subcutaneous (SC) administration. Subjects will receive one or two doses. Doses will be ascending and determined by emerging data.
Matching placebo for PF-06835375 IV or SC. Subjects will receive one or two doses.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
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.
Time frame: 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)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
| Milestone | Placebo IV SAD | PF-06835375 0.03 mg IV SAD | PF-06835375 0.1 mg IV SAD | PF-06835375 0.3 mg IV SAD | PF-06835375 1 mg IV SAD | PF-06835375 3 mg IV SAD | PF-06835375 6 mg IV SAD | Placebo SC MAD | PF-06835375 0.3 mg SC MAD | PF-06835375 1 mg SC MAD | PF-06835375 3 mg SC MAD | PF-06835375 6 mg SC MAD | PF-06835375 10 mg SC MAD |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 8 | 3 | 3 | 3 | 3 | 6 | 5 | 11 | 6 | 6 | 7 | 6 | 6 |
| Completed | 8 | 3 | 3 | 3 | 3 | 6 | 5 | 9 | 6 | 6 | 4 | 5 | 5 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 3 | 1 | 1 |
| Withdrew: Other | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Adverse event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 0 |
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.
| Participants | Placebo IV SAD | PF-06835375 0.03 mg IV SAD | PF-06835375 0.1 mg IV SAD | PF-06835375 0.3 mg IV SAD | PF-06835375 1 mg IV SAD | PF-06835375 3 mg IV SAD | PF-06835375 6 mg IV SAD | Placebo SC MAD | PF-06835375 0.3 mg SC MAD | PF-06835375 1 mg SC MAD | PF-06835375 3 mg SC MAD | PF-06835375 6 mg SC MAD | PF-06835375 10 mg SC MAD |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Number of Participants With Dose-Limiting Toxicity (DLT) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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.
| Participants | Placebo IV SAD | PF-06835375 0.03 mg IV SAD | PF-06835375 0.1 mg IV SAD | PF-06835375 0.3 mg IV SAD | PF-06835375 1 mg IV SAD | PF-06835375 3 mg IV SAD | PF-06835375 6 mg IV SAD | Placebo SC MAD | PF-06835375 0.3 mg SC MAD | PF-06835375 1 mg SC MAD | PF-06835375 3 mg SC MAD | PF-06835375 6 mg SC MAD | PF-06835375 10 mg SC MAD |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mild (all causalities) | 3 | 0 | 1 | 0 | 0 | 3 | 0 | 4 | 2 | 1 | 1 | 1 | 3 |
| Moderate (all causalities) | 4 | 2 | 2 | 2 | 3 | 3 | 4 | 5 | 2 | 3 | 4 | 3 | 3 |
| Severe (all causalities) | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Mild (treatment-related) | 2 | 0 | 1 | 0 | 0 | 4 | 1 | 3 | 3 | 0 | 2 | 1 | 1 |
| Moderate (treatment-related) | 1 | 0 | 0 | 0 | 2 | 2 | 1 | 0 | 0 | 1 | 3 | 1 | 1 |
| Severe (treatment-related) | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
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.
| Participants | Placebo IV SAD | PF-06835375 0.03 mg IV SAD | PF-06835375 0.1 mg IV SAD | PF-06835375 0.3 mg IV SAD | PF-06835375 1 mg IV SAD | PF-06835375 3 mg IV SAD | PF-06835375 6 mg IV SAD | Placebo SC MAD | PF-06835375 0.3 mg SC MAD | PF-06835375 1 mg SC MAD | PF-06835375 3 mg SC MAD | PF-06835375 6 mg SC MAD | PF-06835375 10 mg SC MAD |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Number of Participants with all-causality TEAEs | 8 | 3 | 3 | 2 | 3 | 6 | 5 | 9 | 4 | 4 | 5 | 4 | 6 |
| Number of Participants with all-causality SAEs | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Number of Participants with treatment-related TEAEs | 3 | 0 | 1 | 0 | 2 | 6 | 3 | 3 | 3 | 1 | 5 | 2 | 2 |
| Number of Participants with treatment-related SAEs | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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.
| Participants | Placebo IV SAD | PF-06835375 0.03 mg IV SAD | PF-06835375 0.1 mg IV SAD | PF-06835375 0.3 mg IV SAD | PF-06835375 1 mg IV SAD | PF-06835375 3 mg IV SAD | PF-06835375 6 mg IV SAD | Placebo SC MAD | PF-06835375 0.3 mg SC MAD | PF-06835375 1 mg SC MAD | PF-06835375 3 mg SC MAD | PF-06835375 6 mg SC MAD | PF-06835375 10 mg SC MAD |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Number of Participants With Permanent Discontinuation Due to TEAEs | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
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).
| Participants | Placebo IV SAD | PF-06835375 0.03 mg IV SAD | PF-06835375 0.1 mg IV SAD | PF-06835375 0.3 mg IV SAD | PF-06835375 1 mg IV SAD | PF-06835375 3 mg IV SAD | PF-06835375 6 mg IV SAD | Placebo SC MAD | PF-06835375 0.3 mg SC MAD | PF-06835375 1 mg SC MAD | PF-06835375 3 mg SC MAD | PF-06835375 6 mg SC MAD | PF-06835375 10 mg SC MAD |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Elevated creatine phosphokinase (CPK) | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Elevated liver enzymes (AST and ALT increased) | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Elevated liver function tests (AST and ALT increased) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
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.
| Participants | Placebo IV SAD | PF-06835375 0.03 mg IV SAD | PF-06835375 0.1 mg IV SAD | PF-06835375 0.3 mg IV SAD | PF-06835375 1 mg IV SAD | PF-06835375 3 mg IV SAD | PF-06835375 6 mg IV SAD | Placebo SC MAD | PF-06835375 0.3 mg SC MAD | PF-06835375 1 mg SC MAD | PF-06835375 3 mg SC MAD | PF-06835375 6 mg SC MAD | PF-06835375 10 mg SC MAD |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sitting Systolic BP <90 mmHg | 2 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 1 | 1 | 0 | 0 |
| Maximum Increase from Baseline in Sitting Systolic BP >= 30 mmHg | 4 | 1 | 1 | 1 | 2 | 3 | 1 | 1 | 2 | 2 | 3 | 0 | 1 |
| Maximum Decrease from Baseline in Sitting Systolic BP >= 30 mmHg | 1 | 2 | 1 | 1 | 1 | 1 | 1 | 3 | 0 | 2 | 2 | 2 | 1 |
| Sitting Diastolic BP <50 mmHg | 1 | 1 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 |
| Maximum Increase from Baseline in Sitting Diastolic BP >= 20 mmHg | 3 | 1 | 0 | 0 | 1 | 1 | 1 | 1 | 2 | 2 | 0 | 1 | 2 |
| Maximum Decrease from Baseline in Sitting Diastolic BP >= 20 mmHg | 2 | 0 | 0 | 2 | 2 | 4 | 2 | 4 | 1 | 1 | 2 | 2 | 2 |
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.
| Participants | Placebo IV SAD | PF-06835375 0.03 mg IV SAD | PF-06835375 0.1 mg IV SAD | PF-06835375 0.3 mg IV SAD | PF-06835375 1 mg IV SAD | PF-06835375 3 mg IV SAD | PF-06835375 6 mg IV SAD | Placebo SC MAD | PF-06835375 0.3 mg SC MAD | PF-06835375 1 mg SC MAD | PF-06835375 3 mg SC MAD | PF-06835375 6 mg SC MAD | PF-06835375 10 mg SC MAD |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Maximum QRS (ms) >=140 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 450<= Maximum QTcB Interval (ms) <480 | 4 | 1 | 2 | 0 | 2 | 1 | 3 | 6 | 1 | 1 | 3 | 2 | 3 |
| 480<= Maximum QTcB Interval (ms) <500 | 0 | 1 | 0 | 1 | 1 | 0 | 0 | 2 | 0 | 1 | 1 | 0 | 0 |
| Maximum QTcB Interval (ms) >=500 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 |
| 30<= QTcB Maximum Increase From Baseline (ms) <60 | 4 | 0 | 0 | 0 | 0 | 2 | 4 | 3 | 2 | 1 | 0 | 2 | 3 |
| 450<= Maximum QTcF Interval (ms) <480 | 2 | 2 | 1 | 1 | 1 | 0 | 1 | 4 | 0 | 0 | 3 | 0 | 0 |
| 30<= QTcF Maximum Increase From Baseline (ms) <60 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 |
| 480<= Maximum QTcF Interval (ms) <500 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 |
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.
| Participants | Placebo IV SAD | PF-06835375 0.03 mg IV SAD | PF-06835375 0.1 mg IV SAD | PF-06835375 0.3 mg IV SAD | PF-06835375 1 mg IV SAD | PF-06835375 3 mg IV SAD | PF-06835375 6 mg IV SAD | Placebo SC MAD | PF-06835375 0.3 mg SC MAD | PF-06835375 1 mg SC MAD | PF-06835375 3 mg SC MAD | PF-06835375 6 mg SC MAD | PF-06835375 10 mg SC MAD |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Number of Participants with all-causality Infections and Infestations | 4 | 2 | 3 | 0 | 2 | 1 | 3 | 3 | 2 | 3 | 2 | 0 | 2 |
| Number of Participants with treatment-related Infections and Infestations | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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.
| Percentage of decrease from baseline | Placebo IV SAD | PF-06835375 0.03 mg IV SAD | PF-06835375 0.1 mg IV SAD | PF-06835375 0.3 mg IV SAD | PF-06835375 1 mg IV SAD | PF-06835375 3 mg IV SAD | PF-06835375 6 mg IV SAD | Placebo SC MAD | PF-06835375 0.3 mg SC MAD | PF-06835375 1 mg SC MAD | PF-06835375 3 mg SC MAD | PF-06835375 6 mg SC MAD | PF-06835375 10 mg SC MAD |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| B Cell Maximum Decrease (%) From Baseline Over Time Following Single and Multiple Doses of PF-06835375 | 37.693 ± 43.0477 | 67.283 ± 29.3555 | 84.978 ± 5.9053 | 94.052 ± 2.4246 | 98.546 ± 0.1627 | 98.588 ± 1.0295 | 99.326 ± 0.3272 | 41.854 ± 52.5341 | 91.056 ± 12.6425 | 99.650 ± 0.4036 | 99.287 ± 0.6300 | 99.278 ± 1.4476 | 99.134 ± 0.9983 |
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.
| Percentage of decrease from baseline | Placebo IV SAD | PF-06835375 0.03 mg IV SAD | PF-06835375 0.1 mg IV SAD | PF-06835375 0.3 mg IV SAD | PF-06835375 1 mg IV SAD | PF-06835375 3 mg IV SAD | PF-06835375 6 mg IV SAD | Placebo SC MAD | PF-06835375 0.3 mg SC MAD | PF-06835375 1 mg SC MAD | PF-06835375 3 mg SC MAD | PF-06835375 6 mg SC MAD | PF-06835375 10 mg SC MAD |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| cTfh Cell Depletion Maximum Decrease (%) From Baseline Over Time Following Single and Multiple Doses of PF-06835375 | 45.227 ± 48.6385 | 62.360 ± 23.1206 | 84.994 ± 11.2007 | 89.324 ± 6.3399 | 98.675 ± 1.2762 | 97.283 ± 3.0481 | 97.789 ± 3.1257 | 58.116 ± 52.5069 | 89.540 ± 14.8599 | 95.442 ± 5.3905 | 96.683 ± 1.8503 | 97.721 ± 1.6523 | 98.118 ± 0.8825 |
Cmax is maximum observed serum concentration. Cmax for PF-06835375 was observed directly from data.
| nanogram/milliliter (ng/mL) | PF-06835375 0.03 mg IV SAD | PF-06835375 0.1 mg IV SAD | PF-06835375 0.3 mg IV SAD | PF-06835375 1 mg IV SAD | PF-06835375 3 mg IV SAD | PF-06835375 6 mg IV SAD |
|---|---|---|---|---|---|---|
| Maximum Observed Serum Concentration (Cmax) of PF-06835375 in Part A (SAD) | NA ± NA | NA ± NA | 103.0 ± 197 | 208.7 ± 28 | 994.7 ± 29 | 2645 ± 13 |
Tmax is the time for Cmax. Tmax for PF-06835375 was observed directly from data as time of first occurrence.
| hour (hr) | PF-06835375 0.03 mg IV SAD | PF-06835375 0.1 mg IV SAD | PF-06835375 0.3 mg IV SAD | PF-06835375 1 mg IV SAD | PF-06835375 3 mg IV SAD | PF-06835375 6 mg IV SAD |
|---|---|---|---|---|---|---|
| Time to Reach Cmax (Tmax) of PF-06835375 in Part A (SAD) | NA (NA to NA) | NA (NA to NA) | 2.17 (2.15 to 2.20) | 2.08 (2.07 to 4.15) | 2.24 (2.17 to 4.12) | 3.96 (2.00 to 8.12) |
AUCinf is the area under the serum concentration-time profile from time zero extrapolated to infinite time.
| nanogram*hour/milliliter (ng*hr/mL) | PF-06835375 0.03 mg IV SAD | PF-06835375 0.1 mg IV SAD | PF-06835375 0.3 mg IV SAD | PF-06835375 1 mg IV SAD | PF-06835375 3 mg IV SAD | PF-06835375 6 mg IV SAD |
|---|---|---|---|---|---|---|
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-06835375 in Part A (SAD) | NA ± NA | — | 1573 ± 2409 | 7467 ± 84 | 88190 ± 35 | 288000 ± 30 |
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.
| ng*hr/mL | PF-06835375 0.03 mg IV SAD | PF-06835375 0.1 mg IV SAD | PF-06835375 0.3 mg IV SAD | PF-06835375 1 mg IV SAD | PF-06835375 3 mg IV SAD | PF-06835375 6 mg IV SAD |
|---|---|---|---|---|---|---|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06835375 in Part A (SAD) | NA ± NA | NA ± NA | 1380 ± 2950 | 7327 ± 85 | 87120 ± 36 | 287400 ± 30 |
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.
| ng/mL | PF-06835375 1 mg SC MAD | PF-06835375 3 mg SC MAD | PF-06835375 6 mg SC MAD | PF-06835375 10 mg SC MAD |
|---|---|---|---|---|
| Day 1 | 5.743 ± 148 | 34.82 ± 79 | 77.72 ± 150 | 257.8 ± 204 |
| Day 29 | 26.92 ± 68 | 89.68 ± 93 | 209.6 ± 115 | 262.1 ± 224 |
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.
| hr | PF-06835375 1 mg SC MAD | PF-06835375 3 mg SC MAD | PF-06835375 6 mg SC MAD | PF-06835375 10 mg SC MAD |
|---|---|---|---|---|
| Day 1 | 170 (67.4 to 170) | 168 (72.7 to 361) | 169 (73.3 to 192) | 144 (47.7 to 172) |
| Day 29 | 169 (168 to 169) | 169 (123 to 337) | 171 (120 to 336) | 121 (7.55 to 169) |
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.
| ng*hr/mL | PF-06835375 1 mg SC MAD | PF-06835375 3 mg SC MAD | PF-06835375 6 mg SC MAD | PF-06835375 10 mg SC MAD |
|---|---|---|---|---|
| Day 1 | 1964 ± 130 | 11010 ± 84 | 28070 ± 251 | 70630 ± 202 |
| Day 29 | 9309 ± 62 | 25610 ± 125 | 76450 ± 142 | 88540 ± 154 |
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.
| ng*hr/mL | PF-06835375 1 mg SC MAD | PF-06835375 3 mg SC MAD | PF-06835375 6 mg SC MAD | PF-06835375 10 mg SC MAD |
|---|---|---|---|---|
| AUClast of PF-06835375 Following Multiple Doses in Part B (MAD) | 9346 ± 61 | 22050 ± 146 | 84370 ± 160 | 96610 ± 141 |
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.
| ng/mL | PF-06835375 1 mg SC MAD | PF-06835375 3 mg SC MAD | PF-06835375 6 mg SC MAD | PF-06835375 10 mg SC MAD |
|---|---|---|---|---|
| Minimum Observed Serum Trough Concentration (Cmin) of PF-06835375 Following Multiple Doses in Part B (MAD) | NA ± NA | 6.075 ± 80 | 11.81 ± 434 | 9.410 ± 199 |
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.
| ratio | PF-06835375 1 mg SC MAD | PF-06835375 3 mg SC MAD | PF-06835375 6 mg SC MAD | PF-06835375 10 mg SC MAD |
|---|---|---|---|---|
| Observed Accumulation Ratio (Rac) of PF-06835375 Following Multiple Doses in Part B (MAD) | NA ± NA | 2.410 ± 74 | 2.977 ± 79 | 2.001 ± 209 |
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.
| ratio | PF-06835375 1 mg SC MAD | PF-06835375 3 mg SC MAD | PF-06835375 6 mg SC MAD | PF-06835375 10 mg SC MAD |
|---|---|---|---|---|
| Peak-to-trough Fluctuation (PTF) of PF-06835375 Following Multiple Doses in Part B (MAD) | NA ± NA | 2.037 ± 26 | 1.687 ± 31 | 1.830 ± 35 |
To evaluate the immunogenicity as measured by presence of ADA and NAb in participants treated with PF-06835375.
| Participants | PF-06835375 0.03 mg IV SAD | PF-06835375 0.1 mg IV SAD | PF-06835375 0.3 mg IV SAD | PF-06835375 1 mg IV SAD | PF-06835375 3 mg IV SAD | PF-06835375 6 mg IV SAD | PF-06835375 0.3 mg SC MAD | PF-06835375 1 mg SC MAD | PF-06835375 3 mg SC MAD | PF-06835375 6 mg SC MAD | PF-06835375 10 mg SC MAD |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Number of ADA or NAb evaluable participants with positive ADA | 0 | 0 | 1 | 1 | 3 | 2 | 3 | 3 | 1 | 1 | 2 |
| Number of ADA or NAb evaluable participants with positive NAb | 0 | 0 | 1 | 1 | 3 | 2 | 2 | 1 | 1 | 1 | 2 |
Collected over 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). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo IV SAD | 0/8 (0%) | 1/8 (12.5%) | 8/8 (100%) |
| PF-06835375 0.03 mg IV SAD | 0/3 (0%) | 1/3 (33.3%) | 3/3 (100%) |
| PF-06835375 0.1 mg IV SAD | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| PF-06835375 0.3 mg IV SAD | 0/3 (0%) | 1/3 (33.3%) | 2/3 (66.7%) |
| PF-06835375 1 mg IV SAD | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| PF-06835375 3 mg IV SAD | 0/6 (0%) | 0/6 (0%) | 6/6 (100%) |
| PF-06835375 6 mg IV SAD | 0/5 (0%) | 0/5 (0%) | 5/5 (100%) |
| Placebo SC MAD | 0/11 (0%) | 0/11 (0%) | 9/11 (81.8%) |
| PF-06835375 0.3 mg SC MAD | 0/6 (0%) | 0/6 (0%) | 4/6 (66.7%) |
| PF-06835375 1 mg SC MAD | 0/6 (0%) | 0/6 (0%) | 4/6 (66.7%) |
| PF-06835375 3 mg SC MAD | 0/7 (0%) | 0/7 (0%) | 5/7 (71.4%) |
| PF-06835375 6 mg SC MAD | 0/6 (0%) | 0/6 (0%) | 4/6 (66.7%) |
| PF-06835375 10 mg SC MAD | 0/6 (0%) | 0/6 (0%) | 6/6 (100%) |
| Event | Placebo IV SAD | PF-06835375 0.03 mg IV SAD | PF-06835375 0.1 mg IV SAD | PF-06835375 0.3 mg IV SAD | PF-06835375 1 mg IV SAD | PF-06835375 3 mg IV SAD | PF-06835375 6 mg IV SAD | Placebo SC MAD | PF-06835375 0.3 mg SC MAD | PF-06835375 1 mg SC MAD | PF-06835375 3 mg SC MAD | PF-06835375 6 mg SC MAD | PF-06835375 10 mg SC MAD |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Chest painGeneral disorders | 0/8 | 1/3 | 0/3 | 0/3 | 0/3 | 0/6 | 0/5 | 0/11 | 0/6 | 0/6 | 0/7 | 0/6 | 0/6 |
| HypertensionVascular disorders | 0/8 | 0/3 | 0/3 | 1/3 | 0/3 | 0/6 | 0/5 | 0/11 | 0/6 | 0/6 | 0/7 | 0/6 | 0/6 |
| Acute myocardial infarctionCardiac disorders | 1/8 | 0/3 | 0/3 | 0/3 | 0/3 | 0/6 | 0/5 | 0/11 | 0/6 | 0/6 | 0/7 | 0/6 | 0/6 |
| Arteriosclerosis coronary arteryCardiac disorders | 1/8 | 0/3 | 0/3 | 0/3 | 0/3 | 0/6 | 0/5 | 0/11 | 0/6 | 0/6 | 0/7 | 0/6 | 0/6 |
| Back painMusculoskeletal and connective tissue disorders | 1/8 | 0/3 | 0/3 | 0/3 | 0/3 | 0/6 | 0/5 | 0/11 | 0/6 | 0/6 | 0/7 | 0/6 | 0/6 |
| Neck painMusculoskeletal and connective tissue disorders | 1/8 | 0/3 | 0/3 | 0/3 | 0/3 | 0/6 | 0/5 | 0/11 | 0/6 | 0/6 | 0/7 | 0/6 | 0/6 |
| Event | Placebo IV SAD | PF-06835375 0.03 mg IV SAD | PF-06835375 0.1 mg IV SAD | PF-06835375 0.3 mg IV SAD | PF-06835375 1 mg IV SAD | PF-06835375 3 mg IV SAD | PF-06835375 6 mg IV SAD | Placebo SC MAD | PF-06835375 0.3 mg SC MAD | PF-06835375 1 mg SC MAD | PF-06835375 3 mg SC MAD | PF-06835375 6 mg SC MAD | PF-06835375 10 mg SC MAD |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PyrexiaGeneral disorders | 1/8 | 0/3 | 0/3 | 0/3 | 2/3 | 1/6 | 1/5 | 1/11 | 1/6 | 1/6 | 3/7 | 0/6 | 0/6 |
| HeadacheNervous system disorders | 1/8 | 0/3 | 1/3 | 0/3 | 1/3 | 4/6 | 2/5 | 2/11 | 2/6 | 1/6 | 1/7 | 1/6 | 2/6 |
| Urinary tract infectionInfections and infestations | 0/8 | 1/3 | 2/3 | 0/3 | 1/3 | 0/6 | 1/5 | 0/11 | 1/6 | 2/6 | 0/7 | 0/6 | 1/6 |
| LymphopeniaBlood and lymphatic system disorders | 0/8 | 0/3 | 0/3 | 0/3 | 0/3 | 0/6 | 2/5 | 0/11 | 0/6 | 0/6 | 0/7 | 0/6 | 0/6 |
| Viral upper respiratory tract infectionInfections and infestations | 0/8 | 0/3 | 0/3 | 0/3 | 0/3 | 0/6 | 2/5 | 0/11 | 0/6 | 1/6 | 0/7 | 0/6 | 0/6 |
| PalpitationsCardiac disorders | 0/8 | 0/3 | 0/3 | 0/3 | 0/3 | 2/6 | 0/5 | 0/11 | 0/6 | 0/6 | 0/7 | 0/6 | 0/6 |
| Abdominal painGastrointestinal disorders | 0/8 | 1/3 | 0/3 | 0/3 | 0/3 | 0/6 | 0/5 | 0/11 | 0/6 | 0/6 | 0/7 | 1/6 | 0/6 |
| DiarrhoeaGastrointestinal disorders | 1/8 | 1/3 | 1/3 | 1/3 | 0/3 | 0/6 | 0/5 | 0/11 | 0/6 | 0/6 | 1/7 | 1/6 | 1/6 |
| NauseaGastrointestinal disorders | 1/8 | 1/3 | 0/3 | 0/3 | 1/3 | 2/6 | 0/5 | 0/11 | 1/6 | 1/6 | 1/7 | 0/6 | 0/6 |
| VomitingGastrointestinal disorders | 1/8 | 0/3 | 0/3 | 0/3 | 1/3 | 0/6 | 0/5 | 0/11 | 1/6 | 0/6 | 1/7 | 0/6 | 0/6 |
Baseline analysis population included all enrolled participants who received at least one dose of study treatment.
| Age, Continuous(Years) | Placebo IV SAD | PF-06835375 0.03 mg IV SAD | PF-06835375 0.1 mg IV SAD | PF-06835375 0.3 mg IV SAD | PF-06835375 1 mg IV SAD | PF-06835375 3 mg IV SAD | PF-06835375 6 mg IV SAD | Placebo SC MAD | PF-06835375 0.3 mg SC MAD | PF-06835375 1 mg SC MAD | PF-06835375 3 mg SC MAD | PF-06835375 6 mg SC MAD | PF-06835375 10 mg SC MAD | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean | 50.00 ± 11.58 | 53.33 ± 11.02 | 47.33 ± 15.53 | 57.33 ± 6.03 | 54.00 ± 10.15 | 52.33 ± 13.95 | 54.00 ± 5.66 | 48.64 ± 13.60 | 52.00 ± 10.56 | 54.17 ± 7.70 | 53.57 ± 8.20 | 61.67 ± 10.80 | 58.50 ± 9.25 | 53.26 ± 10.71 |
| Age, Customized(Participants) | Placebo IV SAD | PF-06835375 0.03 mg IV SAD | PF-06835375 0.1 mg IV SAD | PF-06835375 0.3 mg IV SAD | PF-06835375 1 mg IV SAD | PF-06835375 3 mg IV SAD | PF-06835375 6 mg IV SAD | Placebo SC MAD | PF-06835375 0.3 mg SC MAD | PF-06835375 1 mg SC MAD | PF-06835375 3 mg SC MAD | PF-06835375 6 mg SC MAD | PF-06835375 10 mg SC MAD | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| <18 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 18-44 | 3 | 1 | 1 | 0 | 0 | 1 | 0 | 4 | 2 | 0 | 1 | 1 | 1 | 15 |
| 45-64 | 4 | 2 | 2 | 3 | 2 | 4 | 5 | 6 | 4 | 6 | 5 | 2 | 3 | 48 |
| >=65 | 1 | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 1 | 3 | 2 | 10 |
| Sex: Female, Male(Participants) | Placebo IV SAD | PF-06835375 0.03 mg IV SAD | PF-06835375 0.1 mg IV SAD | PF-06835375 0.3 mg IV SAD | PF-06835375 1 mg IV SAD | PF-06835375 3 mg IV SAD | PF-06835375 6 mg IV SAD | Placebo SC MAD | PF-06835375 0.3 mg SC MAD | PF-06835375 1 mg SC MAD | PF-06835375 3 mg SC MAD | PF-06835375 6 mg SC MAD | PF-06835375 10 mg SC MAD | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Female | 7 | 3 | 3 | 2 | 3 | 6 | 5 | 11 | 5 | 4 | 7 | 5 | 4 | 65 |
| Male | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 2 | 0 | 1 | 2 | 8 |
| Ethnicity (NIH/OMB)(Participants) | Placebo IV SAD | PF-06835375 0.03 mg IV SAD | PF-06835375 0.1 mg IV SAD | PF-06835375 0.3 mg IV SAD | PF-06835375 1 mg IV SAD | PF-06835375 3 mg IV SAD | PF-06835375 6 mg IV SAD | Placebo SC MAD | PF-06835375 0.3 mg SC MAD | PF-06835375 1 mg SC MAD | PF-06835375 3 mg SC MAD | PF-06835375 6 mg SC MAD | PF-06835375 10 mg SC MAD | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 0 | 0 | 0 | 3 | 0 | 2 | 1 | 1 | 2 | 0 | 0 | 10 |
| Not Hispanic or Latino | 7 | 3 | 3 | 3 | 3 | 3 | 5 | 9 | 5 | 5 | 5 | 6 | 6 | 63 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Placebo IV SAD | PF-06835375 0.03 mg IV SAD | PF-06835375 0.1 mg IV SAD | PF-06835375 0.3 mg IV SAD | PF-06835375 1 mg IV SAD | PF-06835375 3 mg IV SAD | PF-06835375 6 mg IV SAD | Placebo SC MAD | PF-06835375 0.3 mg SC MAD | PF-06835375 1 mg SC MAD | PF-06835375 3 mg SC MAD | PF-06835375 6 mg SC MAD | PF-06835375 10 mg SC MAD | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 3 | 1 | 1 | 2 | 1 | 2 | 1 | 1 | 0 | 1 | 0 | 1 | 1 | 15 |
| White | 4 | 2 | 2 | 1 | 2 | 4 | 4 | 9 | 6 | 4 | 6 | 5 | 5 | 54 |
| More than one race | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — 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.
Ran from Nov 2017 to primary completion in Feb 2022, 50 months.
Results were first posted in Oct 2023, 1 year 8 months after primary completion.
Of 108 industry-sponsored phase 1 interventional studies under Lupus Erythematosus, Systemic, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 35. This study's 50 months is above that.
Counting every sponsor, half of 147 studies reached it within 28 months; a quarter within 16 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Lupus Erythematosus, Systemic →