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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: IFN-β inhibitor treatment; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital
    • Beijing, Beijing, China, 100089
      • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

1.1. Inclusion Criteria

1. Male and female participants must be 18 to 45 years of age, inclusive, at the time of signing the ICD (informed consent document).
2. 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).
3. BMI (body mass index) of 19 to 27 kg/m2 (inclusive); and a total body weight >50 kg (110 lb).

1.2. Exclusion Criteria

1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
2. 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).
3. History of autoimmune disorders.
4. History of allergic or anaphylactic reaction to a therapeutic drug.
5. History of recent active infections within 28 days prior to the screening visit.
6. Participants with a fever within 7 days prior to dosing.
7. Infected with Mycobacterium TB (tuberculosis)
8. 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.
9. 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.
10. 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.
11. Current use of any prohibited concomitant medication(s) or those unwilling/unable to use a permitted concomitant medication(s).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2022
• Primary Completion (Actual): March 21, 2023
• Study Completion (Actual): March 21, 2023

Study Registration Dates

• First Submitted: February 3, 2022
• First Submitted That Met QC Criteria: February 23, 2022
• First Posted (Actual): February 25, 2022

Study Record Updates

• Last Update Posted (Actual): April 5, 2023
• Last Update Submitted That Met QC Criteria: April 3, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: C0251007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes