Trial Outcomes & Findings for A Study to Learn About The Study Medicine (Called PF-06823859) in Healthy Chinese Participants (NCT NCT05257798)

Results Overview

The Cmax was observed directly from data.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

18 participants

Primary outcome timeframe

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

Results posted on

2024-08-14

Participant Flow

There were 83 participants screened in the study, among whom, 18 participants were assigned to the study treatments.

Participant milestones

Participant milestones
Measure	PF-06823859 900mg Participants received a single intravenous (IV) infusion of PF-06823859 900 mg on Study Day 1	Placebo Participants received a single IV infusion of placebo on Study Day 1
Treatment Phase STARTED	15	3
Treatment Phase COMPLETED	15	3
Treatment Phase NOT COMPLETED	0	0
Follow-up Phase STARTED	15	3
Follow-up Phase COMPLETED	14	3
Follow-up Phase NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	PF-06823859 900mg Participants received a single intravenous (IV) infusion of PF-06823859 900 mg on Study Day 1	Placebo Participants received a single IV infusion of placebo on Study Day 1
Follow-up Phase Lost to Follow-up	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PF-06823859 900mg n=15 Participants Participants received a single intravenous (IV) infusion of PF-06823859 900 mg on Study Day 1.	Placebo n=3 Participants Participants received a single IV infusion of placebo on Study Day 1	Total n=18 Participants Total of all reporting groups
Age, Continuous	33.00 years n=5 Participants	28.00 years n=7 Participants	30.50 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	3 Participants n=7 Participants	16 Participants n=5 Participants
Race/Ethnicity, Customized Chinese	15 Participants n=5 Participants	3 Participants n=7 Participants	18 Participants n=5 Participants

PRIMARY outcome

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

Population: The PK parameter analysis population included all randomized participants who received at least 1 dose of study intervention and at least 1 of the PK parameters was calculated.

The Cmax was observed directly from data.

Outcome measures

Outcome measures
Measure	PF-06823859 900 mg n=10 Participants Participants received a single intravenous (IV) infusion of PF-06823859 900 mg on Study Day 1	Placebo Participants received a single IV infusion of placebo on Study Day 1
Maximum Serum Concentration(Cmax) for PF-06823859	307.4 micrograms/milliliter (ug/mL) Geometric Coefficient of Variation 17	—

PRIMARY outcome

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

Population: The PK parameter analysis population included all randomized participants who received at least 1 dose of study intervention and at least 1 of the PK parameters was calculated.

The Tmax was the time at which Cmax occurs

Outcome measures

Outcome measures
Measure	PF-06823859 900 mg n=10 Participants Participants received a single intravenous (IV) infusion of PF-06823859 900 mg on Study Day 1	Placebo Participants received a single IV infusion of placebo on Study Day 1
Time at Which Cmax Occured (Tmax) for PF-06823859 in Serum	1.52 hour (hr) Interval 1.0 to 12.0	—

PRIMARY outcome

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

Population: The PK parameter analysis population included all randomized participants who received at least 1 dose of study intervention and at least 1 of the PK parameters was calculated.

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

Outcome measures

Outcome measures
Measure	PF-06823859 900 mg n=10 Participants Participants received a single intravenous (IV) infusion of PF-06823859 900 mg on Study Day 1	Placebo Participants received a single IV infusion of placebo on Study Day 1
Area Under the Concentration-time Profile From Time Zero to 14 Days (336 Hours) Post-dose (AUC14day) for PF-06823859 in Serum	48550 ug*hr/mL Geometric Coefficient of Variation 16	—

PRIMARY outcome

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

Population: The PK parameter analysis population included all randomized participants who received at least 1 dose of study intervention and at least 1 of the PK parameters was calculated.

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

Outcome measures

Outcome measures
Measure	PF-06823859 900 mg n=10 Participants Participants received a single intravenous (IV) infusion of PF-06823859 900 mg on Study Day 1	Placebo Participants received a single IV infusion of placebo on Study Day 1
Area Under the Concentration-time Profile From Time Zero to 28 Days (672 Hours) Post-dose (AUC28day) for PF-06823859 in Serum	73240 ug*hr/mL Geometric Coefficient of Variation 17	—

PRIMARY outcome

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

Population: The PK parameter analysis population included all randomized participants who received at least 1 dose of study intervention and at least 1 of the PK parameters was calculated.

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

Outcome measures

Outcome measures
Measure	PF-06823859 900 mg n=10 Participants Participants received a single intravenous (IV) infusion of PF-06823859 900 mg on Study Day 1	Placebo Participants received a single IV infusion of placebo on Study Day 1
Area Under the Serum Concentration-time Profile From Time Zero Extrapolated to Infinite Time(AUCinf) for PF-06823859 in Serum.	127100 ug*hr/mL Geometric Coefficient of Variation 23	—

PRIMARY outcome

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

Population: The analysis population included all randomized participants who received at least 1 dose of study intervention and at least 1 of the PK parameters was calculated.

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

Outcome measures

Outcome measures
Measure	PF-06823859 900 mg n=10 Participants Participants received a single intravenous (IV) infusion of PF-06823859 900 mg on Study Day 1	Placebo Participants received a single IV infusion of placebo on Study Day 1
Terminal Half-life (t1/2) for PF-06823859 in Serum.	26.96 day Standard Deviation 2.6945	—

PRIMARY outcome

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

Population: The safety analysis population included all randomized participants who received at least 1 dose of the study intervention.

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.

Outcome measures

Outcome measures
Measure	PF-06823859 900 mg n=15 Participants Participants received a single intravenous (IV) infusion of PF-06823859 900 mg on Study Day 1	Placebo n=3 Participants Participants received a single IV infusion of placebo on Study Day 1
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Participants with TEAEs	14 Participants	2 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Participants with serious TEAEs	0 Participants	0 Participants

PRIMARY outcome

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

Population: The safety analysis population included all randomized participants who received at least 1 dose of the study intervention.

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.

Outcome measures

Outcome measures
Measure	PF-06823859 900 mg n=15 Participants Participants received a single intravenous (IV) infusion of PF-06823859 900 mg on Study Day 1	Placebo n=3 Participants Participants received a single IV infusion of placebo on Study Day 1
Number of Participants With Pre-Specified Categorization for Vital Signs (Diastolic Blood Pressure)	1 Participants	0 Participants

PRIMARY outcome

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

Population: The safety analysis population included all randomized participants who received at least 1 dose of the study intervention.

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

Outcome measures

Outcome measures
Measure	PF-06823859 900 mg n=15 Participants Participants received a single intravenous (IV) infusion of PF-06823859 900 mg on Study Day 1	Placebo n=3 Participants Participants received a single IV infusion of placebo on Study Day 1
Number of Participants With Pre-Specified Categorization for Vital Signs (Systolic Blood Pressure) Systolic Blood Pressure (mmHg) Change >= 30 mmHg increase	1 Participants	0 Participants
Number of Participants With Pre-Specified Categorization for Vital Signs (Systolic Blood Pressure) Systolic Blood Pressure (mmHg) Change >= 30 mmHg decrease	1 Participants	0 Participants

PRIMARY outcome

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

Population: The safety analysis population included all randomized participants who received at least 1 dose of the study intervention.

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.

Outcome measures

Outcome measures
Measure	PF-06823859 900 mg n=15 Participants Participants received a single intravenous (IV) infusion of PF-06823859 900 mg on Study Day 1	Placebo n=3 Participants Participants received a single IV infusion of placebo on Study Day 1
Number of Participants With Pre-Specified Categorization (Maximum Change From Baseline) for ECG Data	0 Participants	0 Participants

PRIMARY outcome

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

Population: The safety analysis population included all randomized participants who received at least 1 dose of the study intervention.

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

Outcome measures

Outcome measures
Measure	PF-06823859 900 mg n=15 Participants Participants received a single intravenous (IV) infusion of PF-06823859 900 mg on Study Day 1	Placebo n=3 Participants Participants received a single IV infusion of placebo on Study Day 1
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality). URINE Erythrocytes (Scalar) >= 20	2 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality). URINE Hemoglobin >= 1	2 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality). Ery. Mean Corpuscular HGB Concentration (g/L) < 0.9 ✖ Lower Limit Normal (LLN)	1 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality). Lymphocytes (10^9/L) > 1.2 ✖ Upper Limit Normal (ULN)	1 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality). Basophils (10^9/L) > 1.2 ✖ ULN	1 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality). Eosinophils (10^9/L) > 1.2 ✖ ULN	1 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality). Prothrombin Time (s) > 1.1 ✖ ULN	1 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality). Bilirubin (micromol/L) > 1.5 ✖ ULN	1 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality). Urate (mmol/L) > 1.2 ✖ ULN	1 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality). pH (Scalar) >8	1 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality). URINE Leukocytes (Scalar) >= 20	2 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality). Ketones >= 1	1 Participants	0 Participants

PRIMARY outcome

Timeframe: From Screening up to Day157

Population: The safety analysis population included all randomized participants who received at least 1 dose of the study intervention.

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.

Outcome measures

Outcome measures
Measure	PF-06823859 900 mg n=15 Participants Participants received a single intravenous (IV) infusion of PF-06823859 900 mg on Study Day 1	Placebo n=3 Participants Participants received a single IV infusion of placebo on Study Day 1
Number of Participants With Viral Infections	3 Participants	0 Participants

SECONDARY outcome

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

Population: The PK parameter analysis population included all randomized participants who received at least 1 dose of study intervention and at least 1 of the PK parameters was calculated.

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

Outcome measures

Outcome measures
Measure	PF-06823859 900 mg n=10 Participants Participants received a single intravenous (IV) infusion of PF-06823859 900 mg on Study Day 1	Placebo Participants received a single IV infusion of placebo on Study Day 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	124700 ug*hr/mL Geometric Coefficient of Variation 23	—

SECONDARY outcome

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

Population: The PK parameter analysis population included all randomized participants who received at least 1 dose of study intervention and at least 1 of the PK parameters was calculated.

The CL was clearance.

Outcome measures

Outcome measures
Measure	PF-06823859 900 mg n=10 Participants Participants received a single intravenous (IV) infusion of PF-06823859 900 mg on Study Day 1	Placebo Participants received a single IV infusion of placebo on Study Day 1
Clearance(CL) for PF-06823859 in Serum	0.007084 L/hr Geometric Coefficient of Variation 23	—

SECONDARY outcome

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

Population: The PK parameter analysis population included all randomized participants who received at least 1 dose of study intervention and at least 1 of the PK parameters was calculated.

The Vss was volume of distribution.

Outcome measures

Outcome measures
Measure	PF-06823859 900 mg n=10 Participants Participants received a single intravenous (IV) infusion of PF-06823859 900 mg on Study Day 1	Placebo Participants received a single IV infusion of placebo on Study Day 1
Volume of Distribution at Steady State (Vss) for PF-06823859 in Serum	5.800 L Geometric Coefficient of Variation 18	—

SECONDARY outcome

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

Population: The PK parameter analysis population included all randomized participants who received at least 1 dose of study intervention and at least 1 of the PK parameters was calculated.

The MRT was mean residence time.

Outcome measures

Outcome measures
Measure	PF-06823859 900 mg n=10 Participants Participants received a single intravenous (IV) infusion of PF-06823859 900 mg on Study Day 1	Placebo Participants received a single IV infusion of placebo on Study Day 1
Mean Residence Time (MRT) for PF-06823859 in Serum	34.13 Day Geometric Coefficient of Variation 17	—

SECONDARY outcome

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

Population: The immunogenicity analysis population included all randomized participants who received at least 1 dose of study intervention with at least 1 post-treatment anti-drug antibody determination.

The percentage of participants with positive ADA was summarized.

Outcome measures

Outcome measures
Measure	PF-06823859 900 mg n=15 Participants Participants received a single intravenous (IV) infusion of PF-06823859 900 mg on Study Day 1	Placebo Participants received a single IV infusion of placebo on Study Day 1
Number of Participants With Positive Anti-drug Antibody (ADA) of PF-06823859	0 Participants	—

Adverse Events

PF-06823859 900mg

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER

Measure	PF-06823859 900mg n=15 participants at risk Participants received a single intravenous (IV) infusion of PF-06823859 900 mg on Study Day 1.	Placebo n=3 participants at risk Participants received a single IV infusion of placebo on Study Day 1
Gastrointestinal disorders Abdominal pain	13.3% 2/15 • From screening up to Day 157 Serious adverse events(SAE) and non-serious AEs were recorded on the case report form.	0.00% 0/3 • From screening up to Day 157 Serious adverse events(SAE) and non-serious AEs were recorded on the case report form.
Gastrointestinal disorders Change of bowel habit	6.7% 1/15 • From screening up to Day 157 Serious adverse events(SAE) and non-serious AEs were recorded on the case report form.	0.00% 0/3 • From screening up to Day 157 Serious adverse events(SAE) and non-serious AEs were recorded on the case report form.
Gastrointestinal disorders Diarrhoea	13.3% 2/15 • From screening up to Day 157 Serious adverse events(SAE) and non-serious AEs were recorded on the case report form.	0.00% 0/3 • From screening up to Day 157 Serious adverse events(SAE) and non-serious AEs were recorded on the case report form.
Gastrointestinal disorders Regurgitation	6.7% 1/15 • From screening up to Day 157 Serious adverse events(SAE) and non-serious AEs were recorded on the case report form.	0.00% 0/3 • From screening up to Day 157 Serious adverse events(SAE) and non-serious AEs were recorded on the case report form.
Gastrointestinal disorders Toothache	6.7% 1/15 • From screening up to Day 157 Serious adverse events(SAE) and non-serious AEs were recorded on the case report form.	0.00% 0/3 • From screening up to Day 157 Serious adverse events(SAE) and non-serious AEs were recorded on the case report form.
Immune system disorders Hypersensitivity	6.7% 1/15 • From screening up to Day 157 Serious adverse events(SAE) and non-serious AEs were recorded on the case report form.	0.00% 0/3 • From screening up to Day 157 Serious adverse events(SAE) and non-serious AEs were recorded on the case report form.
Infections and infestations COVID-19	20.0% 3/15 • From screening up to Day 157 Serious adverse events(SAE) and non-serious AEs were recorded on the case report form.	0.00% 0/3 • From screening up to Day 157 Serious adverse events(SAE) and non-serious AEs were recorded on the case report form.
Infections and infestations Ear infection	6.7% 1/15 • From screening up to Day 157 Serious adverse events(SAE) and non-serious AEs were recorded on the case report form.	0.00% 0/3 • From screening up to Day 157 Serious adverse events(SAE) and non-serious AEs were recorded on the case report form.
Infections and infestations Nasopharyngitis	20.0% 3/15 • From screening up to Day 157 Serious adverse events(SAE) and non-serious AEs were recorded on the case report form.	33.3% 1/3 • From screening up to Day 157 Serious adverse events(SAE) and non-serious AEs were recorded on the case report form.
Infections and infestations Suspected COVID-19	6.7% 1/15 • From screening up to Day 157 Serious adverse events(SAE) and non-serious AEs were recorded on the case report form.	33.3% 1/3 • From screening up to Day 157 Serious adverse events(SAE) and non-serious AEs were recorded on the case report form.
Investigations Blood bilirubin increased	6.7% 1/15 • From screening up to Day 157 Serious adverse events(SAE) and non-serious AEs were recorded on the case report form.	0.00% 0/3 • From screening up to Day 157 Serious adverse events(SAE) and non-serious AEs were recorded on the case report form.
Investigations Urinary occult blood positive	6.7% 1/15 • From screening up to Day 157 Serious adverse events(SAE) and non-serious AEs were recorded on the case report form.	0.00% 0/3 • From screening up to Day 157 Serious adverse events(SAE) and non-serious AEs were recorded on the case report form.
Metabolism and nutrition disorders Hyperuricaemia	6.7% 1/15 • From screening up to Day 157 Serious adverse events(SAE) and non-serious AEs were recorded on the case report form.	0.00% 0/3 • From screening up to Day 157 Serious adverse events(SAE) and non-serious AEs were recorded on the case report form.
Musculoskeletal and connective tissue disorders Arthralgia	6.7% 1/15 • From screening up to Day 157 Serious adverse events(SAE) and non-serious AEs were recorded on the case report form.	0.00% 0/3 • From screening up to Day 157 Serious adverse events(SAE) and non-serious AEs were recorded on the case report form.
Nervous system disorders Headache	13.3% 2/15 • From screening up to Day 157 Serious adverse events(SAE) and non-serious AEs were recorded on the case report form.	0.00% 0/3 • From screening up to Day 157 Serious adverse events(SAE) and non-serious AEs were recorded on the case report form.
Respiratory, thoracic and mediastinal disorders Cough	6.7% 1/15 • From screening up to Day 157 Serious adverse events(SAE) and non-serious AEs were recorded on the case report form.	0.00% 0/3 • From screening up to Day 157 Serious adverse events(SAE) and non-serious AEs were recorded on the case report form.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	13.3% 2/15 • From screening up to Day 157 Serious adverse events(SAE) and non-serious AEs were recorded on the case report form.	0.00% 0/3 • From screening up to Day 157 Serious adverse events(SAE) and non-serious AEs were recorded on the case report form.
Skin and subcutaneous tissue disorders Rash	13.3% 2/15 • From screening up to Day 157 Serious adverse events(SAE) and non-serious AEs were recorded on the case report form.	0.00% 0/3 • From screening up to Day 157 Serious adverse events(SAE) and non-serious AEs were recorded on the case report form.