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
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- Healthy
- Sponsor
- Pfizer
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Time at Which Cmax Occured (Tmax) for PF-06823859 in Serum
- Status
- Completed
- Last Updated
- last year
Overview
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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Placebo
Participants will receive placebo via IV.
Intervention: Placebo
PF-06823859
Participants will receive 900 mg of PF-06823859 via intravaneous (IV).
Intervention: IFN-β inhibitor treatment
Outcomes
Primary Outcomes
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
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.
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.
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)
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.
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.
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.
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)
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%).
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.
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
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
Secondary Outcomes
- 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.)
- Number of Participants With Positive Anti-drug Antibody (ADA) of PF-06823859(Days 1 (pre-dose), 15,29, 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.)
- 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.)