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Completed

NCT Number: NCT05257798

A Study to Learn About The Study Medicine (Called 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.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peking University Third Hospital, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

IFN-β inhibitor treatment

Drug

PF-06823859 (IFN-β inhibitor) 100 mg/mL solution for injection

Placebo

Other

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

Primary outcomes

  1. Maximum Serum Concentration(Cmax) for PF-06823859

    Time frame: Days 1 (pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157.

    The Cmax was observed directly from data.

  2. Time at Which Cmax Occured (Tmax) for PF-06823859 in Serum

    Time frame: Days 1 (pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157.

    The Tmax was the time at which Cmax occurs

  3. Area Under the Concentration-time Profile From Time Zero to 14 Days (336 Hours) Post-dose (AUC14day) for PF-06823859 in Serum

    Time frame: Days 1 (pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157.

    The AUC14day was area under the concentration-time profile from time zero to 14 days post-dose (336 hours)

  4. Area Under the Concentration-time Profile From Time Zero to 28 Days (672 Hours) Post-dose (AUC28day) for PF-06823859 in Serum

    Time frame: Days 1(pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157.

    The AUC28day was area under the concentration-time profile from time zero to 28 days post-dose (672 hours)

  5. Area Under the Serum Concentration-time Profile From Time Zero Extrapolated to Infinite Time(AUCinf) for PF-06823859 in Serum.

    Time frame: Days 1(pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157.

    The AUCinf was area under the serum concentration-time profile from time zero extrapolated to infinite time

  6. Terminal Half-life (t1/2) for PF-06823859 in Serum.

    Time frame: Days 1(pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157.

    The t1/2 was terminal half-life (time required for the plasma concentration to decline by 50%).

  7. Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    Time frame: From first dose of study drug/Day 1 to Day 157

    An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious AE (SAE) was defined as any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; or other serious situations such as important medical events. TEAEs were events between first dose of study drug and up to follow-up visit that were absent before treatment or that worsened after treatment. AEs presented below were TEAEs. The investigator was required to use clinical judgment to assess the potential relationship between investigational product and each AE, to define an treatment-related AE.

  8. Number of Participants With Pre-Specified Categorization for Vital Signs (Diastolic Blood Pressure)

    Time frame: Days 1 (pre-dose),5,29,57,100,127 and 157.

    Vital signs measurements included supine blood pressure, diastolic blood pressure, pulse rate and temperature. For diastolic blood pressure, the reporting criteria is increase or decrease from baseline of >= 20mmHg or absolute value < 50 mmHg.

  9. Number of Participants With Pre-Specified Categorization for Vital Signs (Systolic Blood Pressure)

    Time frame: Days 1 (pre-dose),5,29,57,100,127 and 157.

    Vital signs measurements included supine blood pressure, diastolic blood pressure, pulse rate and temperature. For systolic blood pressure, the reporting criteria is increase or decrease from baseline of >= 30 mm Hg or absolute value of <90 mmHg

  10. Number of Participants With Pre-Specified Categorization (Maximum Change From Baseline) for ECG Data

    Time frame: Days -1, 5,29,57,100,127 and 157.

    Standard 12 lead ECGs utilizing limb leads (with a 10 second rhythm strip) were collected at pre-specified times using an ECG machine that automatically calculates the heart rate and measures PR, QT, and QTc intervals and QRS complex. For Safely QTc assessments, absolute value of >450msec and < 480msec is defined as mild prolongation; absolute value between 480-500msec or an increase from baseline of 30 -60msec are defined as moderate prolongation; an absolute value of > 500msec or increase from baseline of >60 msec are defined as severe prolongation.

  11. Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality).

    Time frame: Days -1, 2, 5,8,15,29,57,100,127 and 157.

    Safety laboratory assessments included urinalysis, hematology, chemistry and other. All the safety laboratory samples were collected following at least a 4-hour fast.

  12. Number of Participants With Viral Infections

    Time frame: From Screening up to Day157

    Viral infections surveillance was conducted throughout the study for cytomegalovirus (CMV), Epstein Barr virus (EBV), herpes simplex virus type 1 (HSV-1),herpes simplex virus type 2 (HSV-2), varicella zoster virus (VZV)， Human Herpes Virus 6 (HHV6) and COVID-19.

Secondary outcomes

  1. Area Under the Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (Clast) (AUClast) for PF-06823859 in Serum

    Time frame: Days 1(pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157.

    The AUClast was area under the serum concentration-time profile from time zero to the time of the last quantifiable concentration (Clast)

  2. Clearance(CL) for PF-06823859 in Serum

    Time frame: Days 1(pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157.

    The CL was clearance.

  3. Volume of Distribution at Steady State (Vss) for PF-06823859 in Serum

    Time frame: Days 1(pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157.

    The Vss was volume of distribution.

  4. Mean Residence Time (MRT) for PF-06823859 in Serum

    Time frame: Days 1(pre-dose, 1, 2, 6, 12 hours post dose), 2,3,5,15,29,43,57,71,100,127 and 157.

    The MRT was mean residence time.

  5. Number of Participants With Positive Anti-drug Antibody (ADA) of PF-06823859

    Time frame: Days 1 (pre-dose), 15,29, 57, 71, 100, 127 and 157.

    The percentage of participants with positive ADA was summarized.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 25, 2022
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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