Evaluation of Safety, Tolerability and Pharmacokinetics of Single Dose of PF-06480605 in Japanese Healthy Participants

NCT04269538 | Completed Phase 1

• 1 other identifier: B7541006
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 1, randomized, double-blind, third-party open (ie, participant-blind, investigator-blind and sponsor-open), placebo-controlled, dose escalating clinical study to evaluate the safety, tolerability, immunogenicity, PK and PD of PF-06480605 in Japanese healthy adult participants.

Conditions

Healthy

Outcome Measures

Primary Outcomes (7)

• Incidence of treatment related adverse events (AEs).

  Day 0-114

• Incidence, severity and causal relationship of treatment emergent AEs (TEAEs) and withdrawals due to treatment emergent adverse events.

  Day 0-114

• Incidence and magnitude of abnormal laboratory findings.

  Day 0-114

• Incidence of abnormal and clinically relevant changes in pulse rate

  The use of an automated device for measuring pulse rate is acceptable; however, when done manually, pulse rate will be measured in the brachial/radial artery for at least 30 seconds.

  Day 0-114

• Incidence of abnormal and clinically relevant changes in supine blood pressure

  The use of an automated device for measuring blood pressure is acceptable; however, when done manually, pulse rate will be measured in the brachial/radial artery for at least 30 seconds.

  Day 0-114

• Incidence of abnormal and clinically relevant changes in temperature

  Temperature will be measured orally. No eating, drinking, or smoking is allowed for 15 minutes prior to the measurement.

  Day 0-114

• Incidence of abnormal and clinically relevant changes in electrocardiogram

  12-Lead electrocardiograms should be collected using an electrocardiogram machine that automatically calculates the heart rate and measures PR, QT, and QTc intervals and QRS complex. All scheduled ECGs should be performed after the participant has rested quietly for at least 10 minutes in a supine position.

  Day 0-114

Secondary Outcomes (7)

• Maximum observed serum concentration (Cmax)

  Day 0-114

• Time to reach maximum observed serum concentration (Tmax)

  Day 0-114

• Area under the serum concentration-time profile from time zero to 14 days (AUC14 days)

  Day 0-114

• Terminal elimination half-life (t1/2)

  Day 0-114

• Apparent volume of distribution (Vz/F)

  Day 0-114

Study Arms (2)

SAD Cohorts 1-2 Experimental Arm

EXPERIMENTAL

Experimental Arm Active drug 150 mg and 450 mg SC dosing

Drug: PF-06480605

SAD Cohorts 1-2 Placebo Arm

PLACEBO COMPARATOR

Placebo Arm

Drug: Placebo

Interventions

PF-06480605 DRUG

PF-06480605 150 mg and 450 mg SC dosing

Also known as: Cohorts 1 and 2 Active

SAD Cohorts 1-2 Experimental Arm

Placebo DRUG

Placebo SC dosing

SAD Cohorts 1-2 Placebo Arm

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 four Japanese grandparents born in Japan.
• Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, cardiac tests and laboratory tests.
• 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).
• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent document (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.
• Infection with hepatitis B (HBV) according to the following algorithm using the results of positive testing for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) and hepatitis B surface antibody (HBsAb) at screening.
• If HBsAg is positive, the participant must be excluded from participation in the study.
• If HBsAg is negative, HBcAb is positive, and HBsAb is negative, the participant must be excluded from participation in the study.
• If HBsAg is negative, HBcAb is negative, HBsAb is positive, and prior HBV vaccination is unequivocally documented, the participant is eligible for the study and does not require hepatitis B DNA (HBVDNA) monitoring during the study.
• If HBsAg is negative, HBcAb is negative, HBsAb is positive, and no unequivocal documentation of prior HBV vaccination is available, the participant is required to undergo HBVDNA reflex testing:
• History of allergic or anaphylactic reaction to a therapeutic drug.
• History of recent active infections within 28 days prior to the screening visit.
• Participants with a fever within 48 hours prior to dosing.
• History of tuberculosis or active, latent or inadequately treated tuberculosis infection as defined by the following:
• Have evidence of untreated or inadequately treated active or latent Mycobacterium tuberculosis (TB) infection as evidenced by the following:
• A positive QuantiFERON TB Gold In Tube (QFT-G) test or positive or borderline T-SPOT.TB (T Spot) test performed within the 12 weeks prior to Day 1. If the laboratory reports the test as indeterminate, the test should be repeated. If the result of the repeat test is indeterminate, a purified protein derivative (PPD) test may be substituted for the QFT-G test or T-Spot test only with approval from the Pfizer Medical Monitor on a case by case basis.
• Chest radiograph with changes suggestive of active TB infection within 3 months prior to Screening. Chest radiograph should be performed according to local standards of care or country specific guidelines.
• History of either untreated or inadequately treated latent or active TB infection.

Sponsors & Collaborators

• Telavant, Inc.: lead
• Pfizer: collaborator

Study Sites (1)

P-one Clinic

Hachioji-shi, Tokyo, 192-0071, Japan

Location

Related Publications (1)

• Fukuhara K, Neelakantan S, Furihata K, Yuasa H, Shi N, Yamamoto Y, Hung KE. Japanese Phase 1 Study for Global Development of Anti-TL1A Antibody PF-06480605: A Randomized, Placebo-Controlled, Single-Ascending Dose Study. Clin Transl Sci. 2025 Mar;18(3):e70187. doi: 10.1111/cts.70187.

  PMID: 40065559 DERIVED

Related Links

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

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: January 22, 2020
• First Posted: February 17, 2020
• Study Start: February 19, 2020
• Primary Completion: November 11, 2020
• Study Completion: November 11, 2020
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)