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

  • STATUS
    Recruiting
  • End date
    Jun 2, 2023
  • participants needed
    67
  • sponsor
    Pfizer
Updated on 26 March 2022
platelet count
cancer
corticosteroids
heart failure
thrombocytopenia
malignancy
arthritis
administered intravenously
lupus
scleroderma
igiv
progressive systemic sclerosis
graves
splenectomy
immune globulin
Accepts healthy volunteers

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.

Details
Condition Healthy, Primary Immune Thrombocytopenia, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Treatment Placebo Comparator, PF-06755347, PF-06755347 intravenous, Placebo intravenous, PF-06755347 subcutaneous, Placebo subcutaneous, PF-06755347 intravenous healthy participant, Placebo intravenous healthy participant, PF-06755347 subcutaneous healthy participant, Placebo subcutaneous healthy participant, PF-06755347 subcutaneous ITP
Clinical Study IdentifierNCT03275740
SponsorPfizer
Last Modified on26 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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

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
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)
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
Subjects with a history of allergic or anaphylactic reaction to any drug including immunoglobulin
Subjects with a history of thromboembolic events
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