A Study to Learn About The Study Medicine (Called PF-06823859) in Healthy Chinese Participants

Study Overview
=================
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: Are between 18 to 45 years of age, inclusive, at the time of signing the Informed Consent Document (ICD). Are Chinese participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and 12 lead ECG (electrocardiogram). Have a BMI (body mass index) of 19 to 27 kg/m2 (inclusive); and a total body weight >50 kg (110 lb). All participants in this study will receive PF-06823859 or a placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. PF-06823859 will be given as an infusion directly into a vein. We will compare the experiences of people receiving PF-06823859 to those of people who do not. This will help us determine if PF-06823859 is safe and how it behaves inside the human body. Participants will take part in this study for up to 157 days. During this time, they will receive PF-06823859 or placebo and be observed for any effects.

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 participants.

Official Title
-----------------
A PHASE 1, RANDOMIZED, DOUBLE-BLIND, THIRD-PARTY OPEN, PLACEBO CONTROLLED, STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY, AND TOLERABILITY FOLLOWING A SINGLE DOSE OF PF-06823859 IN HEALTHY CHINESE PARTICIPANTS

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: IFN-β inhibitor treatment
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
1.1. 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). 1.2. 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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-06823859<br>Participants will receive 900 mg of PF-06823859 via intravaneous (IV). | Drug: IFN-β inhibitor treatment<br>* PF-06823859 (IFN-β inhibitor) 100 mg/mL solution for injection<br>|
| Placebo Comparator: Placebo<br>Participants will receive placebo via IV. | Other: Placebo<br>* Placebo for PF-06823859, 0 mg/mL solution for injection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) |  | Up to Day 157 | 
| Time to Reach Maximum Observed Plasma Concentration (Tmax) |  | Up to Day 157 | 
| Area under the concentration-time profile from time 0 to 14 days (AUC14 day) post dose |  | Up to Day 157 | 
| Area under the concentration-time profile from time 0 to 28 days (AUC28 day) post dose |  | Up to Day 157 | 
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) |  | Up to Day 157 | 
| Plasma Decay Half-Life (t½) |  | Up to Day 157 | 
| Assessments of adverse events (AEs) and serious adverse events (SAEs) |  | Up to Day 157 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum serum concentration (Cmax dn) |  | Up to Day 157 | 
| Area under the serum concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast) |  | Up to Day 157 | 
| Dose normalized Area under the serum concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast dn) |  | Up to Day 157 | 
| Dose normalized Area under the serum concentration-time profile from time zero extrapolated to infinite time (AUCinf dn) |  | Up to Day 157 | 
| Clearance (CL) |  | Up to Day 157 | 
| Volume of Distribution (Vz) |  | Up to Day 157 | 
| Mean residence time (MRT) |  | Up to Day 157 | 
| Incidence of the Development of Anti-Drug Antibodies (ADA) |  | Up to Day 157 | 
| Incidence of the Development of Neutralizing Antibodies (NAb) |  | Up to Day 157 |