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

NCT05257798 | Completed Phase 1 Results FDA Drug

• 1 other identifier: C0251007
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (12)

• Maximum Serum Concentration(Cmax) for PF-06823859

  The Cmax was observed directly from data.

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

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

  The Tmax was the time at which Cmax occurs

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

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

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

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

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

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

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

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

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

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

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

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

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

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

  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.

  From first dose of study drug/Day 1 to Day 157

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

  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.

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

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

  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

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

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

  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.

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

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

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

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

• Number of Participants With Viral Infections

  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.

  From Screening up to Day157

Secondary Outcomes (5)

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

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

• Clearance(CL) for PF-06823859 in Serum

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

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

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

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

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

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

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

Study Arms (2)

PF-06823859

EXPERIMENTAL

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

Drug: IFN-β inhibitor treatment

Placebo

PLACEBO COMPARATOR

Participants will receive placebo via IV.

Other: Placebo

Interventions

IFN-β inhibitor treatment DRUG

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

PF-06823859

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

Peking University Third Hospital

Beijing, Beijing Municipality, 100089, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Related Links

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

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: February 25, 2022
• Study Start: February 28, 2022
• Primary Completion: March 21, 2023
• Study Completion: March 21, 2023
• Last Updated: August 14, 2024
• Results First Posted: August 14, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)