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Monoclonal Antibodies

PF-06755347 intravenous healthy participant for Thrombocytopenic Purpura

Phase 1
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up hours 0, 12, 24, 48, 72, 120, 168 for all cohorts. hours 1, 3, 5, & 8 for all i.v. cohorts. hour 36 for i.v. cohorts 1-2. days 15, 22, 29, and 36 for subcutaneous and i.v. cohorts 5 exp & 6. days 5, 11, 50 & 71 for subcutaneous cohorts
Awards & highlights

Study Summary

This trial will test a new drug for safety in healthy adults and adults with ITP. The drug's effects on the body will also be studied.

Eligible Conditions
  • Idiopathic Thrombocytopenic Purpura (ITP)
  • Healthy Subjects
  • Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~hours 0, 12, 24, 48, 72, 120, 168 for all cohorts. hours 1, 3, 5, & 8 for all i.v. cohorts. hour 36 for i.v. cohorts 1-2. days 15, 22, 29, and 36 for subcutaneous and i.v. cohorts 5 exp & 6. days 5, 11, 50 & 71 for subcutaneous cohorts
This trial's timeline: 3 weeks for screening, Varies for treatment, and hours 0, 12, 24, 48, 72, 120, 168 for all cohorts. hours 1, 3, 5, & 8 for all i.v. cohorts. hour 36 for i.v. cohorts 1-2. days 15, 22, 29, and 36 for subcutaneous and i.v. cohorts 5 exp & 6. days 5, 11, 50 & 71 for subcutaneous cohorts for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Abnormal Electrocardiogram (ECG)
Number of Participants With Categorical Vital Signs Data
Number of Participants With Clinical Laboratory Abnormalities
+1 more
Secondary outcome measures
Apparent Clearance (CL)
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
+8 more

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: PF-06755347 subcutaneous healthy participantExperimental Treatment1 Intervention
subcutaneous administration
Group II: PF-06755347 subcutaneous ITPExperimental Treatment1 Intervention
subcutaneous
Group III: PF-06755347 intravenous healthy participantExperimental Treatment1 Intervention
intravenous administration
Group IV: Placebo subcutaneous healthy participantPlacebo Group1 Intervention
subcutaneous administration
Group V: Placebo intravenous healthy participantPlacebo Group1 Intervention
intravenous administration

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor
4,562 Previous Clinical Trials
10,907,063 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,471 Previous Clinical Trials
8,088,459 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to register as a participant in this investigation?

"Eligible candidates for this medical trial will have to be under 55 years old, and must present with polyradiculoneuropathy or chronic inflammatory demyelinating. 67 individuals are being recruited."

Answered by AI

Is enrollment into this experiment accessible to individuals currently?

"The information available on clinicaltrials.gov indicates that enrollment for this study is currently open to all eligible participants. The trial was first listed on July 17th 2017 and the most recent changes were applied November 22nd 2022."

Answered by AI

Is the age limit to participate in this trial above thirty years?

"According to the parameters set forth by this study, enrollees must be aged 18 - 55. If one does not meet these requirements there are 82 trials available for individuals under 18 years old and 498 studies suitable for those over 65."

Answered by AI

What deleterious effects can be anticipated from intravenous administration of PF-06755347?

"Due to the experimental nature of PF-06755347 intravenous, its safety rating has been assigned a score of 1. This reflects the current dearth of data available on efficacy and security levels."

Answered by AI
~8 spots leftby Mar 2025