Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05257798 | A Study to Learn About The Study Medicine (Called PF-06823859) in Healthy Chinese Participants | PHASE1 | COMPLETED | 18 | — | — | Feb 28, 2022 | Mar 21, 2023 | Aug 14, 2024 | 2 | China |
The Cmax was observed directly from data.
The Tmax was the time at which Cmax occurs
The AUC14day was area under the concentration-time profile from time zero to 14 days post-dose (336 hours)
The AUC28day was area under the concentration-time profile from time zero to 28 days post-dose (672 hours)
The AUCinf was area under the serum concentration-time profile from time zero extrapolated to infinite time
The t1/2 was terminal half-life (time required for the plasma concentration to decline by 50%).
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.
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.
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
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.
Safety laboratory assessments included urinalysis, hematology, chemistry and other. All the safety laboratory samples were collected following at least a 4-hour fast.
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.
| Arm | Type | Description |
|---|---|---|
| PF-06823859 | EXPERIMENTAL | Participants will receive 900 mg of PF-06823859 via intravaneous (IV). |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo via IV. |
| Name | Type | Description |
|---|---|---|
| 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 |
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 exami...