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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Other: Placebo; Drug: IFN-β inhibitor treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT05257798

C0251007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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18 participants in 2 patient groups, including a placebo group

PF-06823859

Experimental group

Description:

Participants will receive 900 mg of PF-06823859 via intravaneous (IV).

Treatment:

Drug: IFN-β inhibitor treatment

Placebo

Placebo Comparator group

Description:

Participants will receive placebo via IV.

Treatment:

Other: Placebo