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

NCT05037409 | Completed Phase 1 Results

• 1 other identifier: C0251005
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

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

• Number of Participants With Viral Infection

  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.

  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.

  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.

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

Secondary Outcomes (14)

• Maximum Observed Serum Concentration (Cmax) of PF-06823859

  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

  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

  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

  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

  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

Study Arms (3)

PF-06823859 low

EXPERIMENTAL

Participants will receive single intravenous infusion.

Drug: PF-06823859

PF-06823859 high

EXPERIMENTAL

Participants will receive single intravenous infusion.

Drug: PF-06823859

Placebo

PLACEBO COMPARATOR

Participants will receive single intravenous infusion.

Drug: Placebo

Interventions

PF-06823859 DRUG

low dose or high dose intravenous infusion

PF-06823859 high; PF-06823859 low

Placebo DRUG

Intravenous infusion

Placebo

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Medical Corporation Shinanokai Shinanozaka Clinic

Shinjuku-ku, Tokyo, 160-0017, Japan

Location

Related Links

• To obtain contact information for a study center near you, click here.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: September 8, 2021
• Study Start: September 28, 2021
• Primary Completion: March 27, 2022
• Study Completion: March 27, 2022
• Last Updated: December 15, 2023
• Results First Posted: December 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)