A Phase 1 interventional study of PF-06823859 and Placebo in Healthy, sponsored by Pfizer. Completed at 1 site in Japan. Open to participants aged 20 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-15.
Sponsored by Pfizer · Phase 1, Interventional, and Treatment
Purpose of the study is to evaluate the safety, tolerability, immunogenicity and pharmacokinetics (PK) of PF-06823859 following a single intravenous dose of PF-06823859 300 and 900 mg in Japanese healthy adult participants.
Approximately 12 participants are planned to be enrolled into the study. The study consists of 2 cohorts, and approximately 5 participants will be randomized to PF-06823859 and approximately 1 participant will be randomized to placebo in each cohort.
Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
(BMI) of 17.5 to 25 kg/m2; and a total body weight >50 kg (110 lb).
Informed Consent:
Exclusion Criteria:
Participants who have evidence of tuberculosis infection.
Recent exposure to any live or attenuated within 6 weeks of admission to central research unit (CRU)
Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive single intravenous infusion.
Drug: PF-06823859
Participants will receive single intravenous infusion.
Drug: PF-06823859
Participants will receive single intravenous infusion.
Drug: Placebo
low dose or high dose intravenous infusion
Intravenous infusion
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
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. SAE was any untoward medical occurrence that at any dose resulted in any of following outcomes/deemed significant for any other reason: death; initial /prolonged inpatient hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly/birth defect and suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. TEAEs were the events between first dose of study drug and up to Day 157, that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious (if occurred) and all non-serious adverse events.
Time frame: Day 1 up to maximum of Day 157
Number of Participants With Infusion Related Reaction (IRR)
IRR included AEs potentially related to infusion related reaction and was determined by blind medical review prior to the database release.
Time frame: Day 1 up to maximum of Day 157
Number of Participants With Infusion Site Reaction
Participants were monitored from start of study intervention infusion until the end of infusion to assess the infusion sites for erythema, induration, ecchymosis, pain, and pruritus, or other observed characteristics after study intervention.
Time frame: From start of study intervention infusion up to 60 minutes on Day 1
Number of Participants With Viral Infection
Time frame: Day 1 up to maximum of Day 157
Number of Participants With Laboratory Test Abnormalities
Laboratory test abnormalities included hematology: basophils/leukocytes greater than (\>)1.2\* upper limit of normal (ULN), eosinophils/leukocytes \>1.2\* ULN, monocytes/leukocytes \>1.2\* ULN; clinical chemistry: bilirubin \> 1.5\* ULN, aspartate aminotransferase \>3.0\* ULN, urate \>1.2\* ULN; urinalysis: ketones greater than or equal to (\>=)1, urine hemoglobin \>=1.
Time frame: Day 1 up to maximum of Day 157
Number of Participants With Vital Sign Abnormalities of Pre-defined Criteria
Vital sign abnormalities were categorized as: a) supine systolic blood pressure: minimum: less than (\<) 90 millimeter of mercury (mmHg), maximum decrease from baseline: greater than or equal to (\>=) 30 mmHg, maximum increase from baseline: \>=30 mmHg; b) supine diastolic blood pressure: minimum: \<50 mmHg, maximum decrease from baseline: \>=20 mmHg, maximum increase from baseline: \>=20 mmHg; c) supine pulse rate: minimum \<40 beats per minute (bpm), maximum \>120 bpm. Number of participants with any vital sign abnormality were reported in this outcome measure.
Time frame: From baseline (pre-dose measurement at Day 1) up to Day 157
Number of Participants With Electrocardiogram (ECG) Abnormalities of Pre-defined Criteria
Criteria for ECG abnormalities: maximum PR interval \>=300 milliseconds (msec); maximum increase in PR interval from baseline \>=25 percent (%) for baseline value of \>200 msec; maximum increase in PR interval from baseline \>=50% for baseline value of less than or equal to (\<=) 200 msec; maximum QRS interval \>=140 msec and maximum increase from baseline \>=50%; QT interval of \>=500 msec; QTcF interval (Fridericia's Correction of QTc interval) mild: \>=450 msec to \<480 msec, moderate: \>=480 msec to \<500 msec; increase from baseline \>=30 msec to \<60 msec and severe: \>=500 msec; increase from baseline \>=60 msec.
Time frame: From baseline (pre-dose measurement at Day 1) up to Day 157
Maximum Observed Serum Concentration (Cmax) of PF-06823859
Cmax was defined as the maximum observed serum concentration of PF-06823859. Cmax was analyzed and reported consolidated for all the time-points through Day 1 to Day 157.
Time frame: Pre dose on Day 1; 1, 2, 6, 12, 24, 48 and 96 hours post-dose on Day 1; Anytime during site visit at Day 15, 29, 43, 57, 71, 99, 127, 157
Dose Normalized Cmax (Cmax [dn]) of PF-06823859
Cmax was maximum observed serum concentration. Cmax (dn) was calculated as Cmax/dose. Cmax (dn) was analyzed and reported consolidated for all the time-points through Day 1 to Day 157.
Time frame: Pre dose on Day 1; 1, 2, 6, 12, 24, 48 and 96 hours post-dose on Day 1; Anytime during site visit at Day 15, 29, 43, 57, 71, 99, 127, 157
Time to Reach Maximum Observed Serum Concentration (Tmax) of PF-06823859
Tmax was defined as the time to reach maximum observed serum concentration of PF-06823859 and was observed directly from data. Tmax was analyzed and reported consolidated for all the time-points through Day 1 to Day 157.
Time frame: Pre dose on Day 1; 1, 2, 6, 12, 24, 48 and 96 hours post-dose on Day 1; Anytime during site visit at Day 15, 29, 43, 57, 71, 99, 127, 157
Area Under the Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06823859
AUCinf was calculated as AUClast + (Clast\*/kel), where Clast\* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel = terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Area under the curve from time zero to last quantifiable concentration (AUClast) was determined using the linear/log trapezoidal rule. AUCinf was analyzed and reported consolidated for all the time-points through Day 1 to Day 157.
Time frame: Pre dose on Day 1; 1, 2, 6, 12, 24, 48 and 96 hours post-dose on Day 1; Anytime during site visit at Day 15, 29, 43, 57, 71, 99, 127, 157
Dose Normalized AUCinf (AUCinf [dn]) of PF-06823859
AUCinf (dn) was calculated as AUCinf/dose. Where AUCinf was calculated as AUClast + (Clast\*/kel), where Clast\* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel = terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. AUClast was determined using the linear/log trapezoidal rule. AUCinf \[dn\] was analyzed and reported consolidated for all the time-points through Day 1 to Day 157.
Time frame: Pre dose on Day 1; 1, 2, 6, 12, 24, 48 and 96 hours post-dose on Day 1; Anytime during site visit at Day 15, 29, 43, 57, 71, 99, 127, 157
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06823859
AUClast was determined using the linear/log trapezoidal rule. AUClast was analyzed and reported consolidated for all the time-points through Day 1 to Day 157.
Time frame: Pre dose on Day 1; 1, 2, 6, 12, 24, 48 and 96 hours post-dose on Day 1; Anytime during site visit at Day 15, 29, 43, 57, 71, 99, 127, 157
Dose Normalized AUClast (AUClast [dn]) of PF-06823859
AUClast(dn) was calculated as AUClast/dose. AUClast(dn) was analyzed and reported consolidated for all the time-points through Day 1 to Day 157.
Time frame: Pre dose on Day 1; 1, 2, 6, 12, 24, 48 and 96 hours post-dose on Day 1; Anytime during site visit at Day 15, 29, 43, 57, 71, 99, 127, 157
Area Under the Curve From Time Zero to 14 Days (336 Hours) Post-Dose (AUC14day) of PF-06823859
AUC14day = area under the serum concentration-time profile from time 0 to 14 days post-dose. AUC14day was determined using the linear/log trapezoidal rule. AUC14day was analyzed and reported consolidated for all the time-points through Day 1 to Day 14.
Time frame: Pre dose on Day 1; 1, 2, 6, 12, 24, 48, 96 and 336 hours post dose on Day 1
Area Under the Curve From Time Zero to 28 Days (672 Hours) Post-Dose (AUC28day) of PF-06823859
AUC28day = area under the serum concentration-time profile from time 0 to 28 days post-dose. AUC28day was determined using the linear/log trapezoidal rule. AUC28day was analyzed and reported consolidated for all the time-points through Day 1 to Day 28.
Time frame: Pre dose on Day 1; 1, 2, 6, 12, 24, 48, 96, 336 and 672 hours post dose on Day 1
Terminal Half-Life (t1/2) of PF-06823859
Terminal half-life (t1/2) is the time for the serum concentration of a drug to decrease by half of its initial concentration. T1/2 was determined using loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. T1/2 was analyzed and reported consolidated for all the time-points through Day 1 to Day 157.
Time frame: Pre dose on Day 1; 1, 2, 6, 12, 24, 48 and 96 hours post-dose on Day 1; Anytime during site visit at Day 15, 29, 43, 57, 71, 99, 127, 157
Systemic Clearance (CL) of PF-06823859
CL was calculated as Dose divided by AUCinf. AUCinf was calculated as AUClast + (Clast\*/kel), where Clast\* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel = terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. AUClast was determined using the linear/log trapezoidal rule. CL was analyzed and reported consolidated for all the time-points through Day 1 to Day 157.
Time frame: Pre dose on Day 1; 1, 2, 6, 12, 24, 48 and 96 hours post-dose on Day 1; Anytime during site visit at Day 15, 29, 43, 57, 71, 99, 127, 157
Steady-State Volume of Distribution (Vss) of PF-06823859
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Vss was calculated as CL\*Mean residence time (MRT). MRT was calculated as AUMCinf/AUCinf - DOF/2, where AUMCinf is the area under the moment curve from time 0 extrapolated to infinity and DOF is the duration of the IV infusion. Vss was analyzed and reported consolidated for all the time-points through Day 1 to Day 157.
Time frame: Pre dose on Day 1; 1, 2, 6, 12, 24, 48 and 96 hours post-dose on Day 1; Anytime during site visit at Day 15, 29, 43, 57, 71, 99, 127, 157
Mean Residence Time (MRT) of PF-06823859
MRT was calculated as AUMCinf/AUCinf - DOF/2, where AUMCinf is the area under the moment curve from time 0 extrapolated to infinity and DOF is the duration of the IV infusion. MRT was analyzed and reported consolidated for all the time-points through Day 1 to Day 157.
Time frame: Pre dose on Day 1; 1, 2, 6, 12, 24, 48 and 96 hours post-dose on Day 1; Anytime during site visit at Day 15, 29, 43, 57, 71, 99, 127, 157
Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibodies (NAb) for PF-06823859
A participant was ADA positive if (1) baseline ADA titer was missing or negative and participant had \>= 1 post-treatment positive titer (treatment-induced), or (2) positive ADA titer at baseline and had a \>= 0.602 unit increase in titer from baseline in \>= 1 post-treatment sample (treatment-boosted). A participant was NAb positive, if baseline was missing or negative and participant had \>= 1 post-treatment positive. NAb-negative participants included participants who were ADA negative or ADA-positive participants tested post-treatment negative in the NAb assay. Participants who were NAb positive at baseline and had \>= 1 post-treatment positive were handled as NAb negative.
Time frame: Day 1 maximum up to Day 157
| Milestone | Cohort 1: PF-06823859 300 mg | Cohort 2: PF-06823859 900 mg | Placebo |
|---|---|---|---|
| Started | 5 | 6 | 2 |
| Treated | 5 | 5 | 2 |
| Completed | 5 | 5 | 2 |
| Not completed | 0 | 1 | 0 |
| Withdrew: Failure to comply with site instruction | 0 | 1 | 0 |
| Milestone | Cohort 1: PF-06823859 300 mg | Cohort 2: PF-06823859 900 mg | Placebo |
|---|---|---|---|
| Started | 5 | 5 | 2 |
| Completed | 5 | 5 | 2 |
| Not completed | 0 | 0 | 0 |
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. SAE was any untoward medical occurrence that at any dose resulted in any of following outcomes/deemed significant for any other reason: death; initial /prolonged inpatient hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly/birth defect and suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. TEAEs were the events between first dose of study drug and up to Day 157, that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious (if occurred) and all non-serious adverse events.
| Participants | Cohort 1: PF-06823859 300 mg | Cohort 2: PF-06823859 900 mg | Placebo |
|---|---|---|---|
| TEAEs | 4 | 1 | 0 |
| SAEs | 0 | 0 | 0 |
IRR included AEs potentially related to infusion related reaction and was determined by blind medical review prior to the database release.
| Participants | Cohort 1: PF-06823859 300 mg | Cohort 2: PF-06823859 900 mg | Placebo |
|---|---|---|---|
| Number of Participants With Infusion Related Reaction (IRR) | 0 | 0 | 0 |
Participants were monitored from start of study intervention infusion until the end of infusion to assess the infusion sites for erythema, induration, ecchymosis, pain, and pruritus, or other observed characteristics after study intervention.
| Participants | Cohort 1: PF-06823859 300 mg | Cohort 2: PF-06823859 900 mg | Placebo |
|---|---|---|---|
| Number of Participants With Infusion Site Reaction | 0 | 0 | 0 |
| Participants | Cohort 1: PF-06823859 300 mg | Cohort 2: PF-06823859 900 mg | Placebo |
|---|---|---|---|
| Number of Participants With Viral Infection | 0 | 1 | 0 |
Laboratory test abnormalities included hematology: basophils/leukocytes greater than (\>)1.2\* upper limit of normal (ULN), eosinophils/leukocytes \>1.2\* ULN, monocytes/leukocytes \>1.2\* ULN; clinical chemistry: bilirubin \> 1.5\* ULN, aspartate aminotransferase \>3.0\* ULN, urate \>1.2\* ULN; urinalysis: ketones greater than or equal to (\>=)1, urine hemoglobin \>=1.
| Participants | Cohort 1: PF-06823859 300 mg | Cohort 2: PF-06823859 900 mg | Placebo |
|---|---|---|---|
| Number of Participants With Laboratory Test Abnormalities | 2 | 4 | 1 |
Vital sign abnormalities were categorized as: a) supine systolic blood pressure: minimum: less than (\<) 90 millimeter of mercury (mmHg), maximum decrease from baseline: greater than or equal to (\>=) 30 mmHg, maximum increase from baseline: \>=30 mmHg; b) supine diastolic blood pressure: minimum: \<50 mmHg, maximum decrease from baseline: \>=20 mmHg, maximum increase from baseline: \>=20 mmHg; c) supine pulse rate: minimum \<40 beats per minute (bpm), maximum \>120 bpm. Number of participants with any vital sign abnormality were reported in this outcome measure.
| Participants | Cohort 1: PF-06823859 300 mg | Cohort 2: PF-06823859 900 mg | Placebo |
|---|---|---|---|
| Number of Participants With Vital Sign Abnormalities of Pre-defined Criteria | 0 | 0 | 0 |
Criteria for ECG abnormalities: maximum PR interval \>=300 milliseconds (msec); maximum increase in PR interval from baseline \>=25 percent (%) for baseline value of \>200 msec; maximum increase in PR interval from baseline \>=50% for baseline value of less than or equal to (\<=) 200 msec; maximum QRS interval \>=140 msec and maximum increase from baseline \>=50%; QT interval of \>=500 msec; QTcF interval (Fridericia's Correction of QTc interval) mild: \>=450 msec to \<480 msec, moderate: \>=480 msec to \<500 msec; increase from baseline \>=30 msec to \<60 msec and severe: \>=500 msec; increase from baseline \>=60 msec.
| Participants | Cohort 1: PF-06823859 300 mg | Cohort 2: PF-06823859 900 mg | Placebo |
|---|---|---|---|
| Number of Participants With Electrocardiogram (ECG) Abnormalities of Pre-defined Criteria | 0 | 0 | 0 |
Cmax was defined as the maximum observed serum concentration of PF-06823859. Cmax was analyzed and reported consolidated for all the time-points through Day 1 to Day 157.
| Microgram per milliliter | Cohort 1: PF-06823859 300 mg | Cohort 2: PF-06823859 900 mg |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) of PF-06823859 | 134.4 ± 16 | 350.1 ± 10 |
Cmax was maximum observed serum concentration. Cmax (dn) was calculated as Cmax/dose. Cmax (dn) was analyzed and reported consolidated for all the time-points through Day 1 to Day 157.
| Microgram per milliliter per milligram | Cohort 1: PF-06823859 300 mg | Cohort 2: PF-06823859 900 mg |
|---|---|---|
| Dose Normalized Cmax (Cmax [dn]) of PF-06823859 | 0.4483 ± 16 | 0.3890 ± 10 |
Tmax was defined as the time to reach maximum observed serum concentration of PF-06823859 and was observed directly from data. Tmax was analyzed and reported consolidated for all the time-points through Day 1 to Day 157.
| Hours | Cohort 1: PF-06823859 300 mg | Cohort 2: PF-06823859 900 mg |
|---|---|---|
| Time to Reach Maximum Observed Serum Concentration (Tmax) of PF-06823859 | 2.000 (1.00 to 6.00) | 2.000 (1.00 to 2.00) |
AUCinf was calculated as AUClast + (Clast\*/kel), where Clast\* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel = terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Area under the curve from time zero to last quantifiable concentration (AUClast) was determined using the linear/log trapezoidal rule. AUCinf was analyzed and reported consolidated for all the time-points through Day 1 to Day 157.
| Microgram*hour per milliliter | Cohort 1: PF-06823859 300 mg | Cohort 2: PF-06823859 900 mg |
|---|---|---|
| Area Under the Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06823859 | 68070 ± 12 | 178000 ± 16 |
AUCinf (dn) was calculated as AUCinf/dose. Where AUCinf was calculated as AUClast + (Clast\*/kel), where Clast\* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel = terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. AUClast was determined using the linear/log trapezoidal rule. AUCinf \[dn\] was analyzed and reported consolidated for all the time-points through Day 1 to Day 157.
| Microgram*hour/milliliter/milligram | Cohort 1: PF-06823859 300 mg | Cohort 2: PF-06823859 900 mg |
|---|---|---|
| Dose Normalized AUCinf (AUCinf [dn]) of PF-06823859 | 227.1 ± 12 | 197.8 ± 16 |
AUClast was determined using the linear/log trapezoidal rule. AUClast was analyzed and reported consolidated for all the time-points through Day 1 to Day 157.
| Microgram*hour per milliliter | Cohort 1: PF-06823859 300 mg | Cohort 2: PF-06823859 900 mg |
|---|---|---|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06823859 | 66120 ± 12 | 173000 ± 14 |
AUClast(dn) was calculated as AUClast/dose. AUClast(dn) was analyzed and reported consolidated for all the time-points through Day 1 to Day 157.
| Microgram*hour/milliliter/milligram | Cohort 1: PF-06823859 300 mg | Cohort 2: PF-06823859 900 mg |
|---|---|---|
| Dose Normalized AUClast (AUClast [dn]) of PF-06823859 | 220.4 ± 12 | 192.2 ± 14 |
AUC14day = area under the serum concentration-time profile from time 0 to 14 days post-dose. AUC14day was determined using the linear/log trapezoidal rule. AUC14day was analyzed and reported consolidated for all the time-points through Day 1 to Day 14.
| Microgram*hour per milliliter | Cohort 1: PF-06823859 300 mg | Cohort 2: PF-06823859 900 mg |
|---|---|---|
| Area Under the Curve From Time Zero to 14 Days (336 Hours) Post-Dose (AUC14day) of PF-06823859 | 22170 ± 10 | 61170 ± 8 |
AUC28day = area under the serum concentration-time profile from time 0 to 28 days post-dose. AUC28day was determined using the linear/log trapezoidal rule. AUC28day was analyzed and reported consolidated for all the time-points through Day 1 to Day 28.
| Microgram*hour per milliliter | Cohort 1: PF-06823859 300 mg | Cohort 2: PF-06823859 900 mg |
|---|---|---|
| Area Under the Curve From Time Zero to 28 Days (672 Hours) Post-Dose (AUC28day) of PF-06823859 | 35040 ± 10 | 95250 ± 10 |
Terminal half-life (t1/2) is the time for the serum concentration of a drug to decrease by half of its initial concentration. T1/2 was determined using loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. T1/2 was analyzed and reported consolidated for all the time-points through Day 1 to Day 157.
| Days | Cohort 1: PF-06823859 300 mg | Cohort 2: PF-06823859 900 mg |
|---|---|---|
| Terminal Half-Life (t1/2) of PF-06823859 | 32.42 ± 0.70852 | 31.42 ± 4.9505 |
CL was calculated as Dose divided by AUCinf. AUCinf was calculated as AUClast + (Clast\*/kel), where Clast\* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel = terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. AUClast was determined using the linear/log trapezoidal rule. CL was analyzed and reported consolidated for all the time-points through Day 1 to Day 157.
| Liter per hour | Cohort 1: PF-06823859 300 mg | Cohort 2: PF-06823859 900 mg |
|---|---|---|
| Systemic Clearance (CL) of PF-06823859 | 0.004406 ± 12 | 0.005061 ± 16 |
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Vss was calculated as CL\*Mean residence time (MRT). MRT was calculated as AUMCinf/AUCinf - DOF/2, where AUMCinf is the area under the moment curve from time 0 extrapolated to infinity and DOF is the duration of the IV infusion. Vss was analyzed and reported consolidated for all the time-points through Day 1 to Day 157.
| Liter | Cohort 1: PF-06823859 300 mg | Cohort 2: PF-06823859 900 mg |
|---|---|---|
| Steady-State Volume of Distribution (Vss) of PF-06823859 | 4.304 ± 10 | 4.737 ± 7 |
MRT was calculated as AUMCinf/AUCinf - DOF/2, where AUMCinf is the area under the moment curve from time 0 extrapolated to infinity and DOF is the duration of the IV infusion. MRT was analyzed and reported consolidated for all the time-points through Day 1 to Day 157.
| Days | Cohort 1: PF-06823859 300 mg | Cohort 2: PF-06823859 900 mg |
|---|---|---|
| Mean Residence Time (MRT) of PF-06823859 | 40.69 ± 8 | 38.99 ± 15 |
A participant was ADA positive if (1) baseline ADA titer was missing or negative and participant had \>= 1 post-treatment positive titer (treatment-induced), or (2) positive ADA titer at baseline and had a \>= 0.602 unit increase in titer from baseline in \>= 1 post-treatment sample (treatment-boosted). A participant was NAb positive, if baseline was missing or negative and participant had \>= 1 post-treatment positive. NAb-negative participants included participants who were ADA negative or ADA-positive participants tested post-treatment negative in the NAb assay. Participants who were NAb positive at baseline and had \>= 1 post-treatment positive were handled as NAb negative.
| Participants | Cohort 1: PF-06823859 300 mg | Cohort 2: PF-06823859 900 mg |
|---|---|---|
| Positive ADA | 1 | 1 |
| Positive NAb | 1 | 1 |
Collected over Day 1 up to maximum of Day 157. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1: PF-06823859 300 mg | 0/5 (0%) | 0/5 (0%) | 4/5 (80%) |
| Cohort 2: PF-06823859 900 mg | 0/5 (0%) | 0/5 (0%) | 1/5 (20%) |
| Placebo | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Event | Cohort 1: PF-06823859 300 mg | Cohort 2: PF-06823859 900 mg | Placebo |
|---|---|---|---|
| Abdominal pain lowerGastrointestinal disorders | 1/5 | 0/5 | 0/2 |
| Vaccination site painGeneral disorders | 1/5 | 0/5 | 0/2 |
| NasopharyngitisInfections and infestations | 0/5 | 1/5 | 0/2 |
| Road traffic accidentInjury, poisoning and procedural complications | 1/5 | 0/5 | 0/2 |
| Thermal burnInjury, poisoning and procedural complications | 1/5 | 0/5 | 0/2 |
| Alanine aminotransferase increasedInvestigations | 0/5 | 1/5 | 0/2 |
| Aspartate aminotransferase increasedInvestigations | 0/5 | 1/5 | 0/2 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/5 | 1/5 | 0/2 |
| Intervertebral disc protrusionMusculoskeletal and connective tissue disorders | 1/5 | 0/5 | 0/2 |
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
| Age, Continuous(Years) | Cohort 1: PF-06823859 300 mg | Cohort 2: PF-06823859 900 mg | Placebo | Total |
|---|---|---|---|---|
| Mean | 38.80 ± 14.24 | 33.80 ± 13.95 | 35.50 ± 13.44 | 36.17 ± 12.91 |
| Sex: Female, Male(Participants) | Cohort 1: PF-06823859 300 mg | Cohort 2: PF-06823859 900 mg | Placebo | Total |
|---|---|---|---|---|
| Female | 1 | 1 | 2 | 4 |
| Male | 4 | 4 | 0 | 8 |
| Ethnicity (NIH/OMB)(Participants) | Cohort 1: PF-06823859 300 mg | Cohort 2: PF-06823859 900 mg | Placebo | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 5 | 5 | 2 | 12 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Cohort 1: PF-06823859 300 mg | Cohort 2: PF-06823859 900 mg | Placebo | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 5 | 5 | 2 | 12 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 0 | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Ran from Sep 2021 to primary completion in Mar 2022, 5 months.
Results were first posted in Dec 2023, 1 year 8 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Dazukibart