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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05257798
• Other study ID #: C0251007
• Status: Completed
• Phase: Phase 1
• Start date: February 28, 2022
• Est. completion date: March 21, 2023

Study information

• Verified date: April 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 21, 2023
• Est. primary completion date: March 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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).

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• IFN-ß inhibitor treatment
PF-06823859 (IFN-ß inhibitor) 100 mg/mL solution for injection

Other:
• Placebo
Placebo for PF-06823859, 0 mg/mL solution for injection

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax)		Up to Day 157
Primary	Time to Reach Maximum Observed Plasma Concentration (Tmax)		Up to Day 157
Primary	Area under the concentration-time profile from time 0 to 14 days (AUC14 day) post dose		Up to Day 157
Primary	Area under the concentration-time profile from time 0 to 28 days (AUC28 day) post dose		Up to Day 157
Primary	Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)		Up to Day 157
Primary	Plasma Decay Half-Life (t½)		Up to Day 157
Primary	Assessments of adverse events (AEs) and serious adverse events (SAEs)		Up to Day 157
Secondary	Maximum serum concentration (Cmax dn)		Up to Day 157
Secondary	Area under the serum concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast)		Up to Day 157
Secondary	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
Secondary	Dose normalized Area under the serum concentration-time profile from time zero extrapolated to infinite time (AUCinf dn)		Up to Day 157
Secondary	Clearance (CL)		Up to Day 157
Secondary	Volume of Distribution (Vz)		Up to Day 157
Secondary	Mean residence time (MRT)		Up to Day 157
Secondary	Incidence of the Development of Anti-Drug Antibodies (ADA)		Up to Day 157
Secondary	Incidence of the Development of Neutralizing Antibodies (NAb)		Up to Day 157

External Links

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