Status:
COMPLETED
A Study to Learn About The Study Medicine (Called PF-06823859) in Healthy Chinese Participants
Lead Sponsor:
Pfizer
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of this clinical trial is to learn if the study medicine (called PF-06823859) is safe and how it is processed in healthy Chinese participants. This study is seeking participants who: * Ar...
Detailed Description
This is a Phase 1, randomized, double blind, sponsor open, placebo controlled study to evaluate the PK, safety, and tolerability following a single dose of PF 06823859 (900 mg) in healthy Chinese part...
Eligibility Criteria
Inclusion
- 1. Inclusion Criteria
- Male and female participants must be 18 to 45 years of age, inclusive, at the time of signing the ICD (informed consent document).
- Male and female Chinese participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and 12 lead ECG (electrocardiogram).
- BMI (body mass index) of 19 to 27 kg/m2 (inclusive); and a total body weight \>50 kg (110 lb).
- 2. Exclusion Criteria
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
- History of HIV (human immunodeficiency virus) infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg (hepatitis B surface antigen), or HCVAb (hepatitis C antibody).
- History of autoimmune disorders.
- History of allergic or anaphylactic reaction to a therapeutic drug.
- History of recent active infections within 28 days prior to the screening visit.
- Participants with a fever within 7 days prior to dosing.
- Infected with Mycobacterium TB (tuberculosis)
- Contact with positive case of COVID (coronavirus disease)-19 or travel to an area defined as high risk by relevant authority in the past 14 days.
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- 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.
- Current use of any prohibited concomitant medication(s) or those unwilling/unable to use a permitted concomitant medication(s).
Exclusion
Key Trial Info
Start Date :
February 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 21 2023
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT05257798
Start Date
February 28 2022
End Date
March 21 2023
Last Update
August 14 2024
Active Locations (2)
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1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100089
2
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191