Investigation of Safety, Tolerability, Immunogenicity and Pharmacokinetics of Single-Dose of PF-06823859 in Japanese Healthy Participants
NCT ID: NCT05037409
Last Updated: 2023-12-15
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE1
13 participants
INTERVENTIONAL
2021-09-28
2022-03-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
TRIPLE
Study Groups
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PF-06823859 low
Participants will receive single intravenous infusion.
PF-06823859
low dose or high dose intravenous infusion
PF-06823859 high
Participants will receive single intravenous infusion.
PF-06823859
low dose or high dose intravenous infusion
Placebo
Participants will receive single intravenous infusion.
Placebo
Intravenous infusion
Interventions
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PF-06823859
low dose or high dose intravenous infusion
Placebo
Intravenous infusion
Eligibility Criteria
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Inclusion Criteria
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
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.
20 Years
55 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Medical Corporation Shinanokai Shinanozaka Clinic
Shinjuku-ku, Tokyo, Japan
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C0251005
Identifier Type: -
Identifier Source: org_study_id