Investigation of Safety, Tolerability, Immunogenicity and Pharmacokinetics of Single-Dose of PF-06823859 in Japanese Healthy Participants
Condition: Healthy
Intervention: PF-06823859; Placebo
Intervention description: low dose or high dose intravenous infusion; Intravenous infusion
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 13.0
Sex: All
Minimum age: 20 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Purpose of the study is to evaluate the safety, tolerability, immunogenicity and
      pharmacokinetics (PK) of PF-06823859 following a single intravenous dose of PF-06823859 300
      and 900 mg in Japanese healthy adult participants.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female participants must be 20 to 55 years of age, inclusive, at the time of
             signing the Informed Consent Document (ICD).

          2. Participants must have 4 biologically Japanese grandparents born in Japan.

          3. Male and female participants who are overtly healthy as determined by medical
             evaluation including medical history, physical examination, laboratory tests, and 12
             lead electrocardiogram (ECG).

          4. Participants who are willing and able to comply with all scheduled visits, treatment
             plan, laboratory tests, lifestyle considerations, and other study procedures.

          5. Body Mass Index (BMI) of 17.5 to 25 kg/m2; and a total body weight >50 kg (110 lb).

             Informed Consent:

          6. Capable of giving signed informed consent as described in Appendix 1, which includes
             compliance with the requirements and restrictions listed in the ICD and in this
             protocol.

        Exclusion Criteria:

          1. Evidence or history of clinically significant hematological, renal, endocrine,
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or
             allergic disease (including drug allergies, but excluding untreated, asymptomatic,
             seasonal allergies at the time of dosing).

          2. History of human immunodeficiency virus (HIV) infection, hepatitis C or syphilis;
             positive testing for HIV, hepatitis C antibody (HCVAb) or syphilis at screening.

          3. Infection with hepatitis b virus (HBV)

          4. Clinically significant abnormality, including but not limited to current, active
             tuberculosis (TB) or previous inactive TB, general infections, heart failure or
             malignancy, on chest X ray performed at screening or within 12 weeks of screening.

          5. History of autoimmune disorders.

          6. History of allergic or anaphylactic reaction to a therapeutic drug or any components
             in the study intervention.

          7. Participants with clinically significant infections, based on which the investigator
             judges that the participant should not be enrolled in the study, within 28 days prior
             to the screening visit.

          8. Participants with a fever, based on which the investigator judges that the participant
             should not be enrolled in the study, within the last 7 days prior to dosing.

          9. Participants who have evidence of tuberculosis infection.

               -  Participants who have been treated or are currently being treated for active or
                  latent tuberculosis infection are to be excluded.

               -  Participants with a history of either untreated or inadequately treated latent or
                  active tuberculosis infection are to be excluded.

         10. Other medical or psychiatric condition including recent (within the past year) or
             active suicidal ideation/behavior or laboratory abnormality or other conditions or
             situations related to COVID-19 pandemic (eg, Contact with positive case, residence, or
             travel to an area with high incidence) that may increase the risk of study
             participation or, in the investigator's judgment, make the participant inappropriate
             for the study.

         11. Use of prescription or nonprescription drugs and dietary and herbal supplements within
             7 days or 5 half lives (whichever is longer) prior to the first dose of study
             intervention.

         12. Recent exposure to any live or attenuated live virus vaccines within 6 weeks of
             admission to central research unit (CRU)

               -  The use of COVID-19 vaccines (except for live or attenuated live virus vaccines)
                  are allowed before 14 days prior to Day 1 or after discharge from CRU.

         13. Participants who have received PF-0 6823859 or any other interferon (IFN) alpha-or
             IFN-beta therapy at any time in the past.

         14. Previous administration with an investigational drug within 4 months (180 days for
             biologics) or 5 half lives preceding the first dose of study intervention used in this
             study (whichever is longer).

         15. A positive urine drug test.

         16. Screening supine blood pressure (BP) ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic),
             following at least 5 minutes of supine rest. If BP is ≥140 mm Hg (systolic) or ≥90 mm
             Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP
             values should be used to determine the participant's eligibility.

         17. Screening pulse rate (PR) >100 bpm. If the PR is greater than 100 beat per minute
             (bpm), the PR should be repeated 2 more times and the average of the 3 PR values
             should be used to determine the participant's eligibility.

         18. Baseline standard 12 lead ECG that demonstrates clinically relevant abnormalities that
             may affect participant safety or interpretation of study results.

         19. Participants with ANY of the following abnormalities in clinical laboratory tests at
             screening, as assessed by the study specific laboratory and confirmed by a single
             repeat test, if deemed necessary:

               -  Aspartate aminotransferase (AST) or alanine aminotransferase (ALT)level ≥1.5 ×
                  upper limit of normal (ULN);

               -  Total bilirubin level ≥1.5 × ULN; participants with a history of Gilbert's
                  syndrome may have direct bilirubin measured and would be eligible for this study
                  provided the direct bilirubin level is ≤ ULN.

         20. A positive COVID-19 test by polymerase chain reaction (PCR) at screening.

         21. History of alcohol abuse or binge drinking and/or any other illicit drug use or
             dependence within 6 months of screening.

         22. Blood donation (excluding plasma donations) of approximately ≥400 mL within 3 months
             or ≥200 mL within a month prior to dosing. Additionally, approximately ≥400 mL within
             4 months for female participants.

         23. History of sensitivity to heparin or heparin induced thrombocytopenia only if heparin
             is planned to flush intravenous catheters.

         24. History of substance abuse within 12 months of the screening visit.

         25. Pregnant females; breastfeeding females.

         26. Unwilling or unable to comply with the criteria in the Lifestyle Considerations
             section of this protocol.

         27. Investigator site staff or Pfizer employees directly involved in the conduct of the
             study, site staff otherwise supervised by the investigator, and their respective
             family members.