HealthyPhase 1NCT03275740

A First in HumanTrial to Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-06755347

A Phase 1 study testing PF-06755347 intravenous healthy participant, PF-06755347 subcutaneous healthy participant and PF-06755347 subcutaneous ITP in people with Healthy and Primary Immune Thrombocytopenia, run by Pfizer at 6 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy, Primary Immune Thrombocytopenia, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
What is being tested?: PF-06755347 intravenous healthy participant, PF-06755347 subcutaneous healthy participant and PF-06755347 subcutaneous ITP
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 58 participants
Where: 6 sitesin 5 countries
Study dates: 17 Jul 2017to 6 Jan 2023
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.
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

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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).

Who cannot join

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.

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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.
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

Trial locations and contacts

6 sites in 5 countries.

Country

City, postcode or hospital

6 sites in 5 countries

Spain2 sites

Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario Virgen del Rocío
Seville, 41013

Other trials in Spain

United States1 site

Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, 06511

Other trials in United States

Belgium1 site

Pfizer Clinical Research Unit
Brussels, B-1070

Other trials in Belgium

New Zealand1 site

NZCR (New Zealand Clinical Research) OPCO Limited
Christchurch, 8011

Other trials in New Zealand

United Kingdom1 site

Hammersmith Medicines Research (HMR)
London, NW10 7EW

Other trials in United Kingdom

About this study

Official 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

Conditions: Healthy, Primary Immune Thrombocytopenia, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Being tested: PF-06755347 intravenous healthy participant, Placebo intravenous healthy participant, PF-06755347 subcutaneous healthy participant, Placebo subcutaneous healthy participant, PF-06755347 subcutaneous ITP
Medical subject headings: Purpura, Thrombocytopenic, Idiopathic, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PF-06755347 intravenous healthy participantDrug
Single doses of PF-06755347 will be administered intravenously dose levels 1, 2, 3, 4, 5, and 6.
Placebo intravenous healthy participantDrug
Placebo comparator
PF-06755347 subcutaneous healthy participantDrug
single doses of PF-06755347 will be administered subcutaneously at dose levels of SC1, SC2, SC3, SC4, and SC5.
Placebo subcutaneous healthy participantDrug
placebo comparator
PF-06755347 subcutaneous ITPDrug
single doses of PF-06755347 will be administered subcutaneously at 2 dose levels tested in healthy participants

Study groups in NCT03275740
Study group	Role	What they receive
PF-06755347 intravenous healthy participant	Experimental	intravenous administration Receives: Drug: PF-06755347 intravenous healthy participant
Placebo intravenous healthy participant	Placebo comparator	intravenous administration Receives: Drug: Placebo intravenous healthy participant
PF-06755347 subcutaneous healthy participant	Experimental	subcutaneous administration Receives: Drug: PF-06755347 subcutaneous healthy participant
Placebo subcutaneous healthy participant	Placebo comparator	subcutaneous administration Receives: Drug: Placebo subcutaneous healthy participant
PF-06755347 subcutaneous ITP	Experimental	subcutaneous Receives: Drug: PF-06755347 subcutaneous ITP

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs
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.
Measured: Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
Number of Participants With Laboratory Test Abnormalities
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.
Measured: 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.
Number of Participants With Vital Signs Meeting Categorical Criteria
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.
Measured: 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.
Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria
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.
Measured: 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).

Secondary outcomes (25)

Maximum Plasma Concentration (Cmax) of PF-06755347 Following Single IV Dose
Cmax was the highest concentration observed directly from data
Measured: 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.
Cmax of PF-06755347 Following Single SC Dose
Cmax was the highest concentration observed directly from data
Measured: Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.
Dose Normalized Cmax (Cmax(dn)) of PF-06755347 Following Single IV Dose
Cmax(dn) = Cmax/Dose
Measured: 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.
Cmax(dn) of PF-06755347 Following Single SC Dose
Cmax(dn) = Cmax/Dose
Measured: Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.
Time for Cmax (Tmax) of PF-06755347 Following Single IV Dose
Tmax was the time to reach maximum observed plasma concentration, which was observed directly from data as time of first occurrence.
Measured: 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.
Tmax of PF-06755347 Following Single SC Dose
Tmax was the time to reach maximum observed plasma concentration, which was observed directly from data as time of first occurrence.
Measured: Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.
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
AUClast was determined using linear/Log trapezoidal method
Measured: 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.
AUClast of PF-06755347 Following Single SC Dose
AUClast was determined using linear/Log trapezoidal method
Measured: Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.
Dose Normalized AUClast (AUClast(dn)) of PF-06755347 Following Single IV Dose
AUClast(dn) = AUClast/Dose
Measured: 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.
AUClast(dn) of PF-06755347 Following Single SC Dose
AUClast(dn) = AUClast/Dose
Measured: Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.
Area Under the Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06755347 Following Single IV Dose
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.
Measured: 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.
AUCinf of PF-06755347 Following Single SC Dose
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.
Measured: Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.
Dose Normalized AUCinf (AUCinf(dn)) of PF-06755347 Following Single IV Dose
AUCinf(dn) = AUCinf/Dose
Measured: 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.
AUCinf(dn) of PF-06755347 Following Single SC Dose
AUCinf(dn) = AUCinf/Dose
Measured: Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.
Terminal Half-life (t½) of PF-06755347 Following Single IV Dose
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.
Measured: 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.
t½ of PF-06755347 Following Single SC Dose
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.
Measured: Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.
Clearance (CL) of PF-06755347 Following Single IV Dose
CL = Dose/AUCinf Steady state total body clearance equals infusion rate (zero order) divided by steady state plasma concentration of study drug.
Measured: 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.
Apparent Clearance (CL/F) of PF-06755347 Following Single SC Dose
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.
Measured: Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.
Number of Participants With Positive Anti-Drug Antibody to PF-06755347
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.
Measured: Baseline, Study Days 8, 15, and 36 for all treatment cohorts plus Day 71 for SC treatment cohorts
Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints
IFN-γ 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.
Measured: 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.
Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints
TNFα 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.
Measured: 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.
Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints
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.
Measured: 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.
Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints
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.
Measured: 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.
Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints
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.
Measured: 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.
Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints
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.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Jul 20176 Jan 2023

First posted8 Sep 2017
Study start17 Jul 2017
Primary completion6 Jan 2023
Study completion6 Jan 2023

Why it stopped: The Sponsor has decided to terminate the above referenced clinical study for business reasons. There were no safety concerns that led to this decision and there was no impact to participant safety.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Model description: single ascending dose study
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03275740
Sponsor's protocol ID: B7801001
Other IDs: 2018-003315-21, 2018
Status last verified: Jan 2024
First submitted: 6 Jul 2017
Last updated: 5 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT03275740
Acronym / sponsor ID: B7801001
Conditions: Healthy, Primary Immune Thrombocytopenia, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: The Sponsor has decided to terminate the above referenced clinical study for business reasons. There were no safety concerns that led to this decision and there was no impact to participant safety.
Enrolment: 58 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 17 Jul 2017 (actual)
Primary completion: 6 Jan 2023 (actual)
Study completion: 6 Jan 2023 (actual)
First posted: 8 Sep 2017 (actual)
Results: Posted 5 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 5
Model description: single ascending dose study

Arm	Type	Receives
PF-06755347 intravenous healthy participant	Experimental	Drug: PF-06755347 intravenous healthy participantintravenous administration
Placebo intravenous healthy participant	Placebo comparator	Drug: Placebo intravenous healthy participantintravenous administration
PF-06755347 subcutaneous healthy participant	Experimental	Drug: PF-06755347 subcutaneous healthy participantsubcutaneous administration
Placebo subcutaneous healthy participant	Placebo comparator	Drug: Placebo subcutaneous healthy participantsubcutaneous administration
PF-06755347 subcutaneous ITP	Experimental	Drug: PF-06755347 subcutaneous ITPsubcutaneous

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

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.
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).

Key exclusion criteria (21 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PF-06755347 intravenous healthy participantSingle doses of PF-06755347 will be administered intravenously dose levels 1, 2, 3, 4, 5, and 6.	Drug	PF-06755347 intravenous healthy participant
Placebo intravenous healthy participantPlacebo comparator	Drug	Placebo intravenous healthy participant
PF-06755347 subcutaneous healthy participantsingle doses of PF-06755347 will be administered subcutaneously at dose levels of SC1, SC2, SC3, SC4, and SC5.	Drug	PF-06755347 subcutaneous healthy participant
Placebo subcutaneous healthy participantplacebo comparator	Drug	Placebo subcutaneous healthy participant
PF-06755347 subcutaneous ITPsingle doses of PF-06755347 will be administered subcutaneously at 2 dose levels tested in healthy participants	Drug	PF-06755347 subcutaneous ITP

Primary outcome

Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs
Time frame: Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
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.
Number of Participants With Laboratory Test Abnormalities
Time frame: 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.
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.
Number of Participants With Vital Signs Meeting Categorical Criteria
Time frame: 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.
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.
Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria
Time frame: 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).
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.

25 secondary outcomes

Maximum Plasma Concentration (Cmax) of PF-06755347 Following Single IV Dose
Time frame: 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.
Cmax of PF-06755347 Following Single SC Dose
Time frame: Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.
Dose Normalized Cmax (Cmax(dn)) of PF-06755347 Following Single IV Dose
Time frame: 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.
Cmax(dn) of PF-06755347 Following Single SC Dose
Time frame: Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.
Time for Cmax (Tmax) of PF-06755347 Following Single IV Dose
Time frame: 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.
Tmax of PF-06755347 Following Single SC Dose
Time frame: Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.
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
Time frame: 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.
AUClast of PF-06755347 Following Single SC Dose
Time frame: Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.
Dose Normalized AUClast (AUClast(dn)) of PF-06755347 Following Single IV Dose
Time frame: 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.
AUClast(dn) of PF-06755347 Following Single SC Dose
Time frame: Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.
Area Under the Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06755347 Following Single IV Dose
Time frame: 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.
AUCinf of PF-06755347 Following Single SC Dose
Time frame: Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.
Dose Normalized AUCinf (AUCinf(dn)) of PF-06755347 Following Single IV Dose
Time frame: 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.
AUCinf(dn) of PF-06755347 Following Single SC Dose
Time frame: Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.
Terminal Half-life (t½) of PF-06755347 Following Single IV Dose
Time frame: 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.
t½ of PF-06755347 Following Single SC Dose
Time frame: Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.
Clearance (CL) of PF-06755347 Following Single IV Dose
Time frame: 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.
Apparent Clearance (CL/F) of PF-06755347 Following Single SC Dose
Time frame: Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.
Number of Participants With Positive Anti-Drug Antibody to PF-06755347
Time frame: Baseline, Study Days 8, 15, and 36 for all treatment cohorts plus Day 71 for SC treatment cohorts
Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints
Time frame: 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.
Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints
Time frame: 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.
Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints
Time frame: 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.
Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints
Time frame: 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.
Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints
Time frame: 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.
Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints
Time frame: 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.

Results and safety

Results posted to the registry on 5 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1: PF-06755347 0.01 mg/kg IV	3	3
Cohort 2: PF-06755347 0.03 mg/kg IV	3	3
Cohort 3: PF-06755347 0.1 mg/kg IV	3	3
Cohort 4: PF-06755347 0.3 mg/kg IV	3	3
Cohort 5: PF-06755347 1 mg/kg IV	3	2
Cohort 6: PF-06755347 0.7 mg/kg IV	3	2
Cohort 7: PF-06755347 25 mg SC	3	3
Cohort 8: PF-06755347 50 mg SC	6	6
Cohort 9: PF-06755347 100 mg SC	6	5
Cohort 10: PF-06755347 200 mg SC	6	5
Cohort 11: PF-06755347 300 mg SC	3	3
Placebo	16	16

Primary outcome: Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs

Time frame: Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).. Count of participants. Unit: Participants

Measure	Cohort 1: PF-06755347 0.01 mg/kg IV n = 3	Cohort 2: PF-06755347 0.03 mg/kg IV n = 3	Cohort 3: PF-06755347 0.1 mg/kg IV n = 3	Cohort 4: PF-06755347 0.3 mg/kg IV n = 3	Cohort 5: PF-06755347 1 mg/kg IV n = 3	Cohort 6: PF-06755347 0.7 mg/kg IV n = 3	Cohort 7: PF-06755347 25 mg SC n = 3	Cohort 8: PF-06755347 50 mg SC n = 6	Cohort 9: PF-06755347 100 mg SC n = 6	Cohort 10: PF-06755347 200 mg SC n = 6	Cohort 11: PF-06755347 300 mg SC n = 3	Placebo n = 16
All-causality TEAEs	3	2	3	3	3	3	3	6	6	5	3	10
Serious TEAEs	0	0	0	0	0	1	0	0	0	0	0	0
Treatment-related TEAEs	2	2	2	2	3	3	2	5	6	4	3	7
Discontinuations from study due to TEAEs	0	0	0	0	1	0	0	0	0	0	0	0

Population analysed: All participants who received at least 1 dose of study medication.

Primary outcome: Number of Participants With Laboratory Test Abnormalities

Time frame: 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.. Count of participants. Unit: Participants

Measure	Cohort 4: PF-06755347 0.3 mg/kg IV n = 3	Cohort 5: PF-06755347 1 mg/kg IV n = 3	Cohort 6: PF-06755347 0.7 mg/kg IV n = 3	Cohort 8: PF-06755347 50 mg SC n = 6	Cohort 9: PF-06755347 100 mg SC n = 6	Cohort 10: PF-06755347 200 mg SC n = 6	Cohort 11: PF-06755347 300 mg SC n = 3	Placebo n = 16
Mean Platelet Volume > 1.1 x upper limit of normal (ULN)	1	1	0	0	1	0	0	3
Ery. Mean Corpuscular Volume <0.9 x lower limit of normal (LLN)	0	0	0	1	0	1	0	0
Leukocytes <0.6 x LLN	0	0	2	0	0	0	0	0
Lymphocytes <0.8 x LLN	0	1	1	1	1	0	1	1
Ery. Mean Corpuscular Hemoglobin < 0.9 x LLN	0	0	0	0	0	1	0

Primary outcome: Number of Participants With Vital Signs Meeting Categorical Criteria

Measure	Cohort 1: PF-06755347 0.01 mg/kg IV n = 3	Cohort 2: PF-06755347 0.03 mg/kg IV n = 3	Cohort 3: PF-06755347 0.1 mg/kg IV n = 3	Cohort 4: PF-06755347 0.3 mg/kg IV n = 3	Cohort 5: PF-06755347 1 mg/kg IV n = 3	Cohort 6: PF-06755347 0.7 mg/kg IV n = 3	Cohort 7: PF-06755347 25 mg SC n = 3	Cohort 8: PF-06755347 50 mg SC n = 6	Cohort 9: PF-06755347 100 mg SC n = 6	Cohort 10: PF-06755347 200 mg SC n = 6	Cohort 11: PF-06755347 300 mg SC n = 3	Placebo n = 16
Pulse rate <40 bpm	0	0	0	0	0	0	0	0	6	5	3	0
Pulse rate >120 bpm	0	0	0	0	1	0	0	0	0	0	0	0
DBP <50 mmHg	0	0	0	0	0	1	0	0	0	0	0	1
DBP: increase from baseline ≥20 mmHg	0	0	0	0	2	0	0	0	3	1	1	0
DBP: decrease from baseline ≥20 mmHg	1	0	0	0	0	0	0	0	0	0	0	0
SBP <90 mmHg

Primary outcome: Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria

Time frame: 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).. Count of participants. Unit: Participants

Measure	Cohort 1: PF-06755347 0.01 mg/kg IV n = 3	Cohort 2: PF-06755347 0.03 mg/kg IV n = 3	Cohort 3: PF-06755347 0.1 mg/kg IV n = 3	Cohort 4: PF-06755347 0.3 mg/kg IV n = 3	Cohort 5: PF-06755347 1 mg/kg IV n = 3	Cohort 6: PF-06755347 0.7 mg/kg IV n = 3	Cohort 7: PF-06755347 25 mg SC n = 3	Cohort 8: PF-06755347 50 mg SC n = 6	Cohort 9: PF-06755347 100 mg SC n = 6	Cohort 10: PF-06755347 200 mg SC n = 6	Cohort 11: PF-06755347 300 mg SC n = 3	Placebo n = 16
PR interval ≥300 msec	0	0	0	0	0	0	0	0	0	0	0	0
PR interval: percent change from baseline ≥25/50%	0	0	0	0	0	0	0	0	0	0	0	0
QRS duration ≥140 msec	0	0	0	0	0	0	0	0	0	0	0	0
QRS duration: percent change from baseline ≥50%	0	0	0	0	0	0	0	0	0	0	0	0
QTcF interval: ≥450 to <480 msec	0	0	0	0	0	0	0	0	0	0	0

25 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1: PF-06755347 0.01 mg/kg IV	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Cohort 2: PF-06755347 0.03 mg/kg IV	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3
Cohort 3: PF-06755347 0.1 mg/kg IV	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Cohort 4: PF-06755347 0.3 mg/kg IV	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Cohort 5: PF-06755347 1 mg/kg IV	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Cohort 6: PF-06755347 0.7 mg/kg IV	1 of 3 (33.3%)	2 of 3 (66.7%)	0 of 3
Cohort 7: PF-06755347 25 mg SC	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Cohort 8: PF-06755347 50 mg SC	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Cohort 9: PF-06755347 100 mg SC	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Cohort 10: PF-06755347 200 mg SC	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Cohort 11: PF-06755347 300 mg SC	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Placebo	0 of 16 (0%)	10 of 16 (62.5%)	0 of 16

Limitations and caveats (from the sponsor): The study was terminated due to sponsor's business decision.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

6 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Spain, United States, Belgium, New Zealand, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs (time frame: Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03275740.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.