Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03275740
Registration number
NCT03275740
Ethics application status
Date submitted
6/07/2017
Date registered
8/09/2017
Titles & IDs
Public title
A First in HumanTrial to Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-06755347
Query!
Scientific title
A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO -CONTROLLED, FIRST-IN-HUMAN TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF PF 06755347 AFTER SINGLE ASCENDING INTRAVENOUS AND SUBCUTANEOUS DOSING IN HEALTHY ADULT MALE PARTICIPANTS AND OPEN-LABEL AFTER SINGLE SUBCUTANEOUS DOSING IN MALE AND FEMALE PARTICIPANTS WITH PERSISTENT OR CHRONIC PRIMARY IMMUNE THROMBOCYTOPENIA
Query!
Secondary ID [1]
0
0
2018-003315-21
Query!
Secondary ID [2]
0
0
B7801001
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Healthy
0
0
Query!
Primary Immune Thrombocytopenia
0
0
Query!
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
0
0
Query!
Condition category
Condition code
Neurological
0
0
0
0
Query!
Other neurological disorders
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Other inflammatory or immune system disorders
Query!
Neurological
0
0
0
0
Query!
Neurodegenerative diseases
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Autoimmune diseases
Query!
Blood
0
0
0
0
Query!
Haematological diseases
Query!
Blood
0
0
0
0
Query!
Other blood disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - PF-06755347 intravenous healthy participant
Treatment: Drugs - Placebo intravenous healthy participant
Treatment: Drugs - PF-06755347 subcutaneous healthy participant
Treatment: Drugs - Placebo subcutaneous healthy participant
Treatment: Drugs - PF-06755347 subcutaneous ITP
Experimental: PF-06755347 intravenous healthy participant - intravenous administration
Placebo comparator: Placebo intravenous healthy participant - intravenous administration
Experimental: PF-06755347 subcutaneous healthy participant - subcutaneous administration
Placebo comparator: Placebo subcutaneous healthy participant - subcutaneous administration
Experimental: PF-06755347 subcutaneous ITP - subcutaneous
Treatment: Drugs: PF-06755347 intravenous healthy participant
Single doses of PF-06755347 will be administered intravenously dose levels 1, 2, 3, 4, 5, and 6.
Treatment: Drugs: Placebo intravenous healthy participant
Placebo comparator
Treatment: Drugs: PF-06755347 subcutaneous healthy participant
single doses of PF-06755347 will be administered subcutaneously at dose levels of SC1, SC2, SC3, SC4, and SC5.
Treatment: Drugs: Placebo subcutaneous healthy participant
placebo comparator
Treatment: Drugs: PF-06755347 subcutaneous ITP
single doses of PF-06755347 will be administered subcutaneously at 2 dose levels tested in healthy participants
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs
Query!
Assessment method [1]
0
0
Adverse event (AE) was any untoward medical occurrence in the participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Serious AE was any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, or was considered to be an important medical event. Any events occurring following start of treatment or increasing in severity were counted as treatment-emergent. AEs included both serious and non-serious AEs.
Query!
Timepoint [1]
0
0
Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
Query!
Primary outcome [2]
0
0
Number of Participants With Laboratory Test Abnormalities
Query!
Assessment method [2]
0
0
Laboratory test included: hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, absolute and percent total neutrophils, eosinophils, monocytes, basophils and lymphocytes),chemistry (blood urea nitrogen/urea and creatinine, fasting glucose, calcium, sodium, potassium, chloride, total carbon dioxide, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin and total protein),urinalysis(pH, qualitative glucose, qualitative protein, qualitative blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy, urinary albumin to creatinine ratio and urinary protein to creatinine ratio) and other tests. Abnormality was determined by the investigator. Only lab abnormalities with at least 1 occurrence in participants are reported.
Query!
Timepoint [2]
0
0
Baseline, Study Days 1, 2, 4, 6, 8, 11, 15, 22, 29 and 36 for IV treatment cohorts, and Baseline, Study Days 1, 2, 3, 4, 6, 8, 11, 15, 22, 29, 36, 50 and 71 for SC treatment cohorts.
Query!
Primary outcome [3]
0
0
Number of Participants With Vital Signs Meeting Categorical Criteria
Query!
Assessment method [3]
0
0
Supine blood pressure and pulse rate were measured. Categorical classes for vital signs of potential clinical concerns were defined as followed: systolic blood pressure (SBP) \<90 millimeters of mercury (mmHg); diastolic blood pressure (DBP) \<50 mmHg; pulse rate \<40 beats per minute (bpm); pulse rate \>120 bpm, and increase from baseline in SBP =30 mmHg; decrease from baseline in SBP =30 mmHg; increase from baseline in DBP =20 mmHg; decrease from baseline in DBP =20 mmHg. Baseline was defined as the mean of the replicated predose (0 hour) measurement on Day 1.
Query!
Timepoint [3]
0
0
Baseline, Study Days 1, 2, 4, 6, 8, 11, 15, 22, 29 and 36 for IV treatment cohorts, and Baseline, Study Days 1, 2, 3, 4, 6, 8, 11, 15, 22, 29, 36, 50 and 71 for SC treatment cohorts.
Query!
Primary outcome [4]
0
0
Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria
Query!
Assessment method [4]
0
0
Number of participants with ECG findings meeting the following criteria: time between the onset of atrial depolarization and onset of ventricular depolarization (PR interval) =300 msec; time from ECG Q-wave to the end of the S wave corresponding to ventricular depolarization (QRS duration) =140 msec; correct time from ECG Q-wave to the end of the T wave corresponding to electrical systole for heart rate using Fridericia's formula (QTcF interval): =450 to \<480 msec; QTcF interval =480 to \<500 msec; QTcF interval: =500 msec; PR interval percent change from baseline (=25/50%): =25% if baseline \>200 msec or = 50% if baseline =200 msec; QRS duration percent change from baseline =50%; QTcF interval change from baseline: \>30 to =60 msec; QTcF interval change from baseline \>60 msec. Baseline was defined as the average of the triplicate predose recordings collected at 0 hour on Day 1.
Query!
Timepoint [4]
0
0
Baseline (Study Day 1, predose), Study Days 1 (postdose), 2, 4, 6, 8, 11, 22, 36 (end of study visit for IV treatment cohorts) and 71 (end of study visit for SC treatment cohorts).
Query!
Secondary outcome [1]
0
0
Maximum Plasma Concentration (Cmax) of PF-06755347 Following Single IV Dose
Query!
Assessment method [1]
0
0
Cmax was the highest concentration observed directly from data
Query!
Timepoint [1]
0
0
Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6.
Query!
Secondary outcome [2]
0
0
Cmax of PF-06755347 Following Single SC Dose
Query!
Assessment method [2]
0
0
Cmax was the highest concentration observed directly from data
Query!
Timepoint [2]
0
0
Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.
Query!
Secondary outcome [3]
0
0
Dose Normalized Cmax (Cmax(dn)) of PF-06755347 Following Single IV Dose
Query!
Assessment method [3]
0
0
Cmax(dn) = Cmax/Dose
Query!
Timepoint [3]
0
0
Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6.
Query!
Secondary outcome [4]
0
0
Cmax(dn) of PF-06755347 Following Single SC Dose
Query!
Assessment method [4]
0
0
Cmax(dn) = Cmax/Dose
Query!
Timepoint [4]
0
0
Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.
Query!
Secondary outcome [5]
0
0
Time for Cmax (Tmax) of PF-06755347 Following Single IV Dose
Query!
Assessment method [5]
0
0
Tmax was the time to reach maximum observed plasma concentration, which was observed directly from data as time of first occurrence.
Query!
Timepoint [5]
0
0
Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6.
Query!
Secondary outcome [6]
0
0
Tmax of PF-06755347 Following Single SC Dose
Query!
Assessment method [6]
0
0
Tmax was the time to reach maximum observed plasma concentration, which was observed directly from data as time of first occurrence.
Query!
Timepoint [6]
0
0
Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.
Query!
Secondary outcome [7]
0
0
Area Under the Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06755347 Following Single IV Dose
Query!
Assessment method [7]
0
0
AUClast was determined using linear/Log trapezoidal method
Query!
Timepoint [7]
0
0
Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6.
Query!
Secondary outcome [8]
0
0
AUClast of PF-06755347 Following Single SC Dose
Query!
Assessment method [8]
0
0
AUClast was determined using linear/Log trapezoidal method
Query!
Timepoint [8]
0
0
Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.
Query!
Secondary outcome [9]
0
0
Dose Normalized AUClast (AUClast(dn)) of PF-06755347 Following Single IV Dose
Query!
Assessment method [9]
0
0
AUClast(dn) = AUClast/Dose
Query!
Timepoint [9]
0
0
Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6.
Query!
Secondary outcome [10]
0
0
AUClast(dn) of PF-06755347 Following Single SC Dose
Query!
Assessment method [10]
0
0
AUClast(dn) = AUClast/Dose
Query!
Timepoint [10]
0
0
Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.
Query!
Secondary outcome [11]
0
0
Area Under the Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06755347 Following Single IV Dose
Query!
Assessment method [11]
0
0
AUClast + (Clast\*/kel), where Clast\* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Query!
Timepoint [11]
0
0
Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6.
Query!
Secondary outcome [12]
0
0
AUCinf of PF-06755347 Following Single SC Dose
Query!
Assessment method [12]
0
0
AUClast + (Clast\*/kel), where Clast\* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Query!
Timepoint [12]
0
0
Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.
Query!
Secondary outcome [13]
0
0
Dose Normalized AUCinf (AUCinf(dn)) of PF-06755347 Following Single IV Dose
Query!
Assessment method [13]
0
0
AUCinf(dn) = AUCinf/Dose
Query!
Timepoint [13]
0
0
Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6.
Query!
Secondary outcome [14]
0
0
AUCinf(dn) of PF-06755347 Following Single SC Dose
Query!
Assessment method [14]
0
0
AUCinf(dn) = AUCinf/Dose
Query!
Timepoint [14]
0
0
Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.
Query!
Secondary outcome [15]
0
0
Terminal Half-life (t½) of PF-06755347 Following Single IV Dose
Query!
Assessment method [15]
0
0
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. t½ = Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Query!
Timepoint [15]
0
0
Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6.
Query!
Secondary outcome [16]
0
0
t½ of PF-06755347 Following Single SC Dose
Query!
Assessment method [16]
0
0
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. t½ = Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Query!
Timepoint [16]
0
0
Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.
Query!
Secondary outcome [17]
0
0
Clearance (CL) of PF-06755347 Following Single IV Dose
Query!
Assessment method [17]
0
0
CL = Dose/AUCinf Steady state total body clearance equals infusion rate (zero order) divided by steady state plasma concentration of study drug.
Query!
Timepoint [17]
0
0
Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6.
Query!
Secondary outcome [18]
0
0
Apparent Clearance (CL/F) of PF-06755347 Following Single SC Dose
Query!
Assessment method [18]
0
0
CL/F = Dose/AUCinf Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Query!
Timepoint [18]
0
0
Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.
Query!
Secondary outcome [19]
0
0
Number of Participants With Positive Anti-Drug Antibody to PF-06755347
Query!
Assessment method [19]
0
0
Human serum samples were analyzed for the presence or absence of anti-PF-06755347 antibodies (ADA) following a tiered approach of screening, confirmation and titer determination, using an electrochemiluminescent (ECL) immunoassay. Baseline was the measurement on Day -1.
Query!
Timepoint [19]
0
0
Baseline, Study Days 8, 15, and 36 for all treatment cohorts plus Day 71 for SC treatment cohorts
Query!
Secondary outcome [20]
0
0
Change From Baseline in Interferon Gamma (IFN-? ) at Scheduled Timepoints
Query!
Assessment method [20]
0
0
IFN-? was one of the 3 cytokine biomarkers explored in the study. Baseline was defined as the average of measurement on Day -1 and pre-dose (0 hours) measurement on Day 1.
Query!
Timepoint [20]
0
0
Day -1, hours 0, 5, 12, 24, 48, 72 for all treatment cohorts. Hours 1 (or end of infusion), 8, and 120 and Days 11 and 29 for IV treatment cohorts; Days 5, 8, 15, 36 and 71 for SC treatment cohorts.
Query!
Secondary outcome [21]
0
0
Change From Baseline in Tumor Necrosis Factor Alpha (TNFa) at Scheduled Timepoints
Query!
Assessment method [21]
0
0
TNFa was one of the 3 cytokine biomarkers explored in the study. Baseline was defined as the average of measurement on Day -1 and pre-dose (0 hours) measurement on Day 1.
Query!
Timepoint [21]
0
0
Day -1, hours 0, 5, 12, 24, 48, 72 for all treatment cohorts. Hours 1 (or end of infusion), 8, and 120 and Days 11 and 29 for IV treatment cohorts; Days 5, 8, 15, 36 and 71 for SC treatment cohorts.
Query!
Secondary outcome [22]
0
0
Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints
Query!
Assessment method [22]
0
0
IL-6 was one of the 3 cytokine biomarkers explored in the study. Baseline was defined as the average of measurement on Day -1 and pre-dose (0 hours) measurement on Day 1.
Query!
Timepoint [22]
0
0
Day -1, hours 0, 5, 12, 24, 48, 72 for all treatment cohorts. Hours 1 (or end of infusion), 8, and 120 and Days 11 and 29 for IV treatment cohorts; Days 5, 8, 15, 36 and 71 for SC treatment cohorts.
Query!
Secondary outcome [23]
0
0
Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints
Query!
Assessment method [23]
0
0
C3a was one of the 3 complement components/biomarkers explored in the study. Baseline was defined as the average of measurement on Day -1 and pre-dose (0 hours) measurement on Day 1.
Query!
Timepoint [23]
0
0
Day -1, hours 0, 5, 12, 24, 48, 72 for all treatment cohorts. Hours 1 (or end of infusion), 8, and 120 and Days 11 and 29 for IV treatment cohorts; Days 5, 8, 15, 36 and 71 for SC treatment cohorts.
Query!
Secondary outcome [24]
0
0
Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints
Query!
Assessment method [24]
0
0
C5a was one of the 3 complement components/biomarkers explored in the study. Baseline was defined as the average of measurement on Day -1 and pre-dose (0 hours) measurement on Day 1.
Query!
Timepoint [24]
0
0
Day -1, hours 0, 5, 12, 24, 48, 72 for all treatment cohorts. Hours 1 (or end of infusion), 8, and 120 and Days 11 and 29 for IV treatment cohorts; Days 5, 8, 15, 36 and 71 for SC treatment cohorts.
Query!
Secondary outcome [25]
0
0
Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints
Query!
Assessment method [25]
0
0
Bb was one of the complement components/biomarkers explored in the study. Baseline was defined as the average of measurement on Day -1 and pre-dose (0 hours) measurement on Day 1.
Query!
Timepoint [25]
0
0
Day -1, hours 0, 5, 12, 24, 48, 72 for all treatment cohorts. Hours 1 (or end of infusion), 8, and 120 and Days 11 and 29 for IV treatment cohorts; Days 5, 8, 15, 36 and 71 for SC treatment cohorts.
Query!
Eligibility
Key inclusion criteria
Inclusion Criteria Healthy male participants:
* at the time of screening, are between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including oral temperature, blood pressure (BP) and pulse rate measurement, pulse oximetry, 12 lead ECG or clinical laboratory tests.
* Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
* Chest X ray with no evidence of current, active tuberculosis (TB) or previous inactive TB, general infections, heart failure, malignancy, or other clinically significant abnormalities taken at Screening or within 3 months prior to Screening and read by a qualified radiologist.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
55
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
Exclusion Criteria for Healthy male participants:
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Participants with a history of autoimmune disorders and other conditions that compromise or impair the immune system (including but not limited to: Crohns Disease, rheumatoid arthritis, scleroderma, systemic lupus erythematosus, Graves disease, and asthma) or have a current positive result for the following; rheumatoid factor, anti-nuclear antibody, or abnormal free triiodothyronine (T3), free thyroxine (T4), thyroid stimulating hormone (TSH), or thyroid stimulating antibody (TSAb) suggestive of thyroid disease.
* Subjects with a history of allergic or anaphylactic reaction to any drug including immunoglobulin.
* History of active infections within 28 days prior to the screening visit.
* Subjects with a history of or current positive results for any of the following serological tests: Hepatitis B surface antigen (HepBsAg), Hepatitis B core antibody (HepBcAb), Hepatitis C antibody (HCVAb) or human immunodeficiency virus (HIV).
* Subjects with a history of thromboembolic events.
* History of TB or active, latent or inadequately treated TB infection. All positive TB test result(s) are exclusionary
* Male subjects with partners currently pregnant; male subjects able to father children who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study.
* Inclusion Criteria for ITP participants:
Female participants may be of childbearing potential or non-childbearing potential.
-Diagnosis of Primary ITP. ITP must be diagnosed in accordance with established guidelines. ITP duration-Persistent (>3 months and =12 months) OR Chronic (>12 months).
AND
* Platelet count 30-75 x 10E9/L (inclusive) with criteria achieved on 2 qualifying counts at least 5 days apart and within approx. 10 days of dosing
* Participants must have received and responded to IVIg or corticosteroids as treatment for ITP (response is defined as achievement of platelet count >50 x 109/L and doubling of platelet count from baseline).
--Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
* BMI of 17.5 to 30.5 kg/m2 and a total body weight >40 kg (88 lbs).
Exclusion Criteria for ITP participants
* History of clinically significant hematological (other than ITP), renal, endocrine, metabolic, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Chest X-ray with evidence of current, active TB, previous inactive TB, general infections, heart failure, malignancy, or other clinically significant abnormalities.
Chest x-ray must be taken at Screening or within 3 months prior to Screening and read by a qualified radiologist.
* Any bleeding event requiring medical evaluation or treatment in the 4 weeks prior to screening or current bleeding event that requires treatment.
* Scheduled or anticipated invasive procedures (eg, surgery, dental procedures) within 28 days following PF-06755347 dosing.
* Splenectomy within =180 days prior to PF-06755347 dosing or splenectomy planned during the period of the study.
* History of any active autoimmune disorder (other than ITP) or other conditions that may compromise or impair the immune system (including but not limited to: Crohn's Disease, rheumatoid arthritis, scleroderma, systemic lupus erythematosus, Graves' disease, and asthma).
* History of allergic or anaphylactic reaction to any drug including immunoglobulin.
* History of active infections within 28 days prior to the screening visit.
* History of Hepatitis B, Hepatitis C or HIV or current positive results for any of the following serological tests - HBsAg, HBcAb, HCVAb or HIV.
* History of thromboembolic events
* Hemoglobin <9 g/dL.
* Positive Direct Coombs test
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Other
Query!
Other design features
Query!
Phase
Phase 1
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Stopped early
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
17/07/2017
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
6/01/2023
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
58
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Connecticut
Query!
Country [2]
0
0
Belgium
Query!
State/province [2]
0
0
Brussels
Query!
Country [3]
0
0
New Zealand
Query!
State/province [3]
0
0
Christchurch
Query!
Country [4]
0
0
Spain
Query!
State/province [4]
0
0
Madrid
Query!
Country [5]
0
0
Spain
Query!
State/province [5]
0
0
Sevilla
Query!
Country [6]
0
0
United Kingdom
Query!
State/province [6]
0
0
London
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Pfizer
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This phase 1 single ascending dose study will provide a first in human assessment of safety and tolerability of PF-06755347 in healthy adult males as well as adult males and females with Immune Thrombocytopenia (ITP). Pharmacokinetics and pharmacodynamics will also be evaluated.
Query!
Trial website
https://clinicaltrials.gov/study/NCT03275740
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Pfizer CT.gov Call Center
Query!
Address
0
0
Pfizer
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
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.
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/40/NCT03275740/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/40/NCT03275740/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03275740