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HealthyPhase 1NCT05037409

Investigation of Safety, Tolerability, Immunogenicity and Pharmacokinetics of Single-Dose of PF-06823859 in Japanese Healthy Participants

A Phase 1 study testing PF-06823859 in people with Healthy, run by Pfizer at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
PF-06823859
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
13 participants
Where
1 siteJapan
Study dates
28 Sep 2021to 27 Mar 2022
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male and female participants must be 20 to 55 years of age, inclusive, at the time of signing the Informed Consent Document (ICD).
  • Participants must have 4 biologically Japanese grandparents born in Japan.
  • Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and 12 lead electrocardiogram (ECG).
  • Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
  • Body Mass Index (BMI) of 17.5 to 25 kg/m2; and a total body weight >50 kg (110 lb).
  • Informed Consent:
  • Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.

Who cannot join

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
  • History of human immunodeficiency virus (HIV) infection, hepatitis C or syphilis; positive testing for HIV, hepatitis C antibody (HCVAb) or syphilis at screening.
  • Infection with hepatitis b virus (HBV)
  • Clinically significant abnormality, including but not limited to current, active tuberculosis (TB) or previous inactive TB, general infections, heart failure or malignancy, on chest X ray performed at screening or within 12 weeks of screening.
  • History of autoimmune disorders.
  • History of allergic or anaphylactic reaction to a therapeutic drug or any components in the study intervention.
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  • Participants with clinically significant infections, based on which the investigator judges that the participant should not be enrolled in the study, within 28 days prior to the screening visit.
  • Participants with a fever, based on which the investigator judges that the participant should not be enrolled in the study, within the last 7 days prior to dosing.
  • Participants who have evidence of tuberculosis infection.
  • Participants who have been treated or are currently being treated for active or latent tuberculosis infection are to be excluded.
  • Participants with a history of either untreated or inadequately treated latent or active tuberculosis infection are to be excluded.
  • Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions or situations related to COVID-19 pandemic (eg, Contact with positive case, residence, or travel to an area with high incidence) 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.
  • Recent exposure to any live or attenuated live virus vaccines within 6 weeks of admission to central research unit (CRU)
  • The use of COVID-19 vaccines (except for live or attenuated live virus vaccines) are allowed before 14 days prior to Day 1 or after discharge from CRU.
  • Participants who have received PF-0 6823859 or any other interferon (IFN) alpha-or IFN-beta therapy at any time in the past.
  • Previous administration with an investigational drug within 4 months (180 days for biologics) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer).
  • A positive urine drug test.
  • Screening supine blood pressure (BP) ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest. If BP is ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility.
  • Screening pulse rate (PR) >100 bpm. If the PR is greater than 100 beat per minute (bpm), the PR should be repeated 2 more times and the average of the 3 PR values should be used to determine the participant's eligibility.
  • Baseline standard 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.
  • 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:
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT)level ≥1.5 × upper limit of normal (ULN);
  • Total bilirubin level ≥1.5 × ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ ULN.
  • A positive COVID-19 test by polymerase chain reaction (PCR) at screening.
  • History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of screening.
  • Blood donation (excluding plasma donations) of approximately ≥400 mL within 3 months or ≥200 mL within a month prior to dosing. Additionally, approximately ≥400 mL within 4 months for female participants.
  • History of sensitivity to heparin or heparin induced thrombocytopenia only if heparin is planned to flush intravenous catheters.
  • History of substance abuse within 12 months of the screening visit.
  • Pregnant females; breastfeeding females.
  • Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol.
  • Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Medical Corporation Shinanokai Shinanozaka Clinic

    Shinjuku-ku, Tokyo, 160-0017

Other trials in Japan

About this study

Official title: A PHASE 1, RANDOMIZED, DOUBLE BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY AND PHARMACOKINETICS FOLLOWING SINGLE INTRAVENOUS DOSE OF PF-06823859 IN JAPANESE HEALTHY PARTICIPANTS

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.

Read the detailed description

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.

Conditions
Healthy
Being tested
PF-06823859, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-06823859Drug

    low dose or high dose intravenous infusion

  • PlaceboDrug

    Intravenous infusion

Study groups in NCT05037409
Study groupRoleWhat they receive
PF-06823859 lowExperimentalParticipants will receive single intravenous infusion.
Receives: Drug: PF-06823859
PF-06823859 highExperimentalParticipants will receive single intravenous infusion.
Receives: Drug: PF-06823859
PlaceboPlacebo comparatorParticipants will receive single intravenous infusion.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 1 up to maximum of Day 157

  2. 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.

    Measured: Day 1 up to maximum of Day 157

  3. 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.

    Measured: From start of study intervention infusion up to 60 minutes on Day 1

  4. Number of Participants With Viral Infection

    Measured: Day 1 up to maximum of Day 157

  5. 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.

    Measured: Day 1 up to maximum of Day 157

  6. 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.

    Measured: From baseline (pre-dose measurement at Day 1) up to Day 157

  7. 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.

    Measured: From baseline (pre-dose measurement at Day 1) up to Day 157

Secondary outcomes (14)

  1. 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.

    Measured: 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

  2. 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.

    Measured: 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

  3. 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.

    Measured: 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

  4. 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.

    Measured: 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

  5. 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.

    Measured: 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

  6. 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.

    Measured: 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

  7. 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.

    Measured: 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

  8. 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.

    Measured: Pre dose on Day 1; 1, 2, 6, 12, 24, 48, 96 and 336 hours post dose on Day 1

  9. 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.

    Measured: Pre dose on Day 1; 1, 2, 6, 12, 24, 48, 96, 336 and 672 hours post dose on Day 1

  10. 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.

    Measured: 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

  11. 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.

    Measured: 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

  12. 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.

    Measured: 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

  13. 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.

    Measured: 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

  14. 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.

    Measured: Day 1 maximum up to Day 157

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2021
  2. Study start28 Sep 2021
  3. Primary completion27 Mar 2022
  4. Study completion27 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05037409
Sponsor's protocol ID
C0251005
Status last verified
Mar 2023
First submitted
11 Aug 2021
Last updated
15 Dec 2023
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Chen N, Sano Y, Wang X, Hu S, Tabira J, Luo X, Yoshimatsu H, Prybylski J, Chu M, Li H, Takazawa K. Pharmacokinetics, Safety, and Tolerability of Single-Dose Dazukibart in Healthy Adults in China and Japan: Results From 2 Randomized, Double-Blind, Phase 1 Studies. Clin Pharmacol Drug Dev. 2025 Aug;14(8):572-582. doi: 10.1002/cpdd.1522. Epub 2025 May 22.

    PubMed 40401504

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-06823859 in people with Healthy, run by Pfizer at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Day 1 up to maximum of Day 157). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05037409, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023; AzTrials last refreshed its copy on 8 Nov 2026.

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