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

  • STATUS
    Recruiting
  • End date
    Mar 31, 2023
  • participants needed
    67
  • sponsor
    Pfizer
Updated on 29 September 2021
cancer
heart failure
malignancy
administered intravenously

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 male subjects. The pharmacokinetics and pharmacodynamics will also be evaluated.

Details
Condition IDIOPATHIC THROMBOCYTOPENIC PURPURA, Autoimmune disease, Chronic inflammatory demyelinating polyradiculoneuropathy, Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Primary Immune Thrombocytopenia, Idiopathic Thrombocytopenic Purpura (ITP), Thrombocytopenic
Treatment Placebo Comparator, PF-06755347, PF-06755347 intravenous, Placebo intravenous, PF-06755347 subcutaneous, Placebo subcutaneous
Clinical Study IdentifierNCT03275740
SponsorPfizer
Last Modified on29 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Healthy male participants who, 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

Exclusion Criteria

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 or current positive result for anti-cardiolipin antibody
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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