HealthyPhase 1NCT04269538
Evaluation of Safety, Tolerability and Pharmacokinetics of Single Dose of PF-06480605 in Japanese Healthy Participants
A Phase 1 study testing PF-06480605 in people with Healthy, run by Telavant, Inc. at 1 site in Japan.
Trial 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. 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-06480605
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteJapan
- Study dates
- 19 Feb 2020to 11 Nov 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 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.
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.
- 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 all three tests are negative, the participant is eligible for study inclusion.
- 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.
Show all 38Show fewer
- 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:
- If HBVDNA is detected, the participant must be excluded from participation in the study; ii. If HBVDNA is undetectable, the participant is eligible for study inclusion. If the participant is included in the study, for subsequent visits HBVDNA testing must be performed according to the Schedule of Activities.
- If HBsAg is negative, HBcAb is positive, and HBsAb is positive, the participant is required to undergo HBVDNA reflex testing: i. If HBVDNA is detected, the participant must be excluded from participation in the study; ii. If HBVDNA is undetectable, the participant is eligible for study inclusion. If the participant is included in the study, for subsequent visits HBVDNA testing must be performed according to the Schedule of Activities.
- 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.
- If a participant has previously received an adequate course of therapy for either latent (9 months of isoniazid in a locale where rates of primary multi drug resistant TB infection are <5% or an acceptable alternative regimen) or active (acceptable multi drug regimen) TB infection, neither a QFT-G test, a T-Spot test, nor a PPD test need be obtained. Details of the previous course of therapy (eg, medication(s) used, dose, duration of therapy) should be documented in the source documentation.
- A chest radiograph should be obtained if not done within the 3 months prior to Screening. To be considered eligible for the study, the chest radiograph must be negative for active TB infection.
- A participant who is currently being treated for active TB infection must be excluded from the study.
- A participant who is being treated for latent TB infection can only be enrolled with confirmation of current incidence rates of multi drug resistant TB infection, documentation of an adequate treatment regimen, and prior approval of the Sponsor.
- Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this 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 investigational product.
- Recent exposure to live vaccines within 28 days of the screening visit.
- Known exposure to anti-TL1A (PF-06480605) or any type of anti-TL1A therapy.
- Previous administration with an investigational drug within 4 months (or as determined by the local requirement) or 5 half lives preceding the first dose of investigational product 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.
- Baseline 12 lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, baseline corrected QT (QTc) interval >450 msec, complete left bundle branch block [LBBB], signs of an acute or indeterminate age myocardial infarction, ST T interval changes suggestive of myocardial ischemia, second or third degree atrioventricular [AV] block, or serious bradyarrhythmias or tachyarrhythmias). If the baseline uncorrected QT interval is >450 msec, this interval should be rate corrected using the Fridericia method and the resulting QTcF should be used for decision making and reporting. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTc or QRS values should be used to determine the participant's eligibility. Computer interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding participants.
- History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5 (male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule, alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1 ounce (30 mL) of 40% spirit or 3 ounces (90 mL) of wine).
- Blood donation (excluding plasma donations and platelet 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.
- History of substance abuse within 12 months of the screening visit.
- Pregnant females; breastfeeding females.
- Males who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and until discharge from the study.
- Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol.
- Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or Pfizer employees, including their family members, directly involved in the conduct of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A PHASE 1, RANDOMIZED, DOUBLE-BLIND, THIRD-PARTY OPEN, PLACEBO-CONTROLLED, DOSE ESCALATING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS FOLLOWING SINGLE SUBCUTANEOUS DOSE OF PF-06480605 IN JAPANESE HEALTHY PARTICIPANTS
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.
Read the detailed description
Approximately 16 participants are planned to be enrolled into the study. The study consists of 2 cohorts, and approximately 6 participants will be randomized to PF-06480605 and approximately 2 participants will be randomized to placebo in each cohort. Each participant will receive PF-06480605 or placebo subcutaneously.
- Conditions
- Healthy
- Being tested
- PF-06480605, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-06480605Drug
Also called Cohorts 1 and 2 Active
PF-06480605 150 mg and 450 mg SC dosing
PlaceboDrug
Placebo SC dosing
| Study group | Role | What they receive |
|---|---|---|
| SAD Cohorts 1-2 Experimental Arm | Experimental | Experimental Arm Active drug 150 mg and 450 mg SC dosing Receives: Drug: PF-06480605 |
| SAD Cohorts 1-2 Placebo Arm | Placebo comparator | Placebo Arm Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment related adverse events (AEs).
Measured: Day 0-114
Incidence, severity and causal relationship of treatment emergent AEs (TEAEs) and withdrawals due to treatment emergent adverse events.
Measured: Day 0-114
Incidence and magnitude of abnormal laboratory findings.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 0-114
Secondary outcomes (7)
Maximum observed serum concentration (Cmax)
Measured: Day 0-114
Time to reach maximum observed serum concentration (Tmax)
Measured: Day 0-114
Area under the serum concentration-time profile from time zero to 14 days (AUC14 days)
Measured: Day 0-114
Terminal elimination half-life (t1/2)
Measured: Day 0-114
Apparent volume of distribution (Vz/F)
Measured: Day 0-114
Apparent total body clearance (CL/F)
Measured: Day 0-114
Immunogenicity of PF-06480605
Incidence of the development of anti-drug antibody (ADA) and neutralizing antibody (NAb)
Measured: Day 0-114
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start19 Feb 2020
- Primary completion11 Nov 2020
- Study completion11 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Telavant, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04269538
- Sponsor's protocol ID
- B7541006
- Status last verified
- Oct 2023
- First submitted
- 22 Jan 2020
- Last updated
- 19 Oct 2023
- Results posted
- No
- 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
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.
PubMed 40065559
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, RANDOMIZED, DOUBLE-BLIND, THIRD-PARTY OPEN, PLACEBO-CONTROLLED, DOSE ESCALATING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS FOLLOWING SINGLE SUBCUTANEOUS DOSE OF PF-06480605 IN JAPANESE HEALTHY PARTICIPANTS
- ClinicalTrials.gov ID
- NCT04269538
- Acronym / sponsor ID
- B7541006
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Telavant, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- 19 Feb 2020 (actual)
- Primary completion
- 11 Nov 2020 (actual)
- Study completion
- 11 Nov 2020 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Approximately 16 participants are planned to be enrolled into the study. The study consists of 2 cohorts, and approximately 6 participants will be randomized to PF-06480605 and approximately 2 participants will be randomized to placebo in each cohort. Each participant will receive PF-06480605 or placebo subcutaneously.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAD Cohorts 1-2 Experimental Arm | Experimental | Drug: PF-06480605Experimental Arm Active drug 150 mg and 450 mg SC dosing |
| SAD Cohorts 1-2 Placebo Arm | Placebo comparator | Drug: PlaceboPlacebo Arm |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (38 listed)
- 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.
- History of allergic or anaphylactic reaction to a therapeutic drug.
- History of recent active infections within 28 days prior to the screening visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PF-06480605Also: Cohorts 1 and 2 ActivePF-06480605 150 mg and 450 mg SC dosing | Drug | SAD Cohorts 1-2 Experimental Arm |
| PlaceboPlacebo SC dosing | Drug | SAD Cohorts 1-2 Placebo Arm |
Primary outcome
Incidence of treatment related adverse events (AEs).
Time frame: Day 0-114
Incidence, severity and causal relationship of treatment emergent AEs (TEAEs) and withdrawals due to treatment emergent adverse events.
Time frame: Day 0-114
Incidence and magnitude of abnormal laboratory findings.
Time frame: Day 0-114
Incidence of abnormal and clinically relevant changes in pulse rate
Time frame: Day 0-114
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.
Incidence of abnormal and clinically relevant changes in supine blood pressure
Time frame: Day 0-114
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.
Incidence of abnormal and clinically relevant changes in temperature
Time frame: Day 0-114
Temperature will be measured orally. No eating, drinking, or smoking is allowed for 15 minutes prior to the measurement.
Incidence of abnormal and clinically relevant changes in electrocardiogram
Time frame: Day 0-114
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.
7 secondary outcomes
Maximum observed serum concentration (Cmax)
Time frame: Day 0-114
Time to reach maximum observed serum concentration (Tmax)
Time frame: Day 0-114
Area under the serum concentration-time profile from time zero to 14 days (AUC14 days)
Time frame: Day 0-114
Terminal elimination half-life (t1/2)
Time frame: Day 0-114
Apparent volume of distribution (Vz/F)
Time frame: Day 0-114
Apparent total body clearance (CL/F)
Time frame: Day 0-114
Immunogenicity of PF-06480605
Time frame: Day 0-114
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Derived from this study: PubMed 40065559Fukuhara 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.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-06480605 in people with Healthy, run by Telavant, Inc. 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 6 inclusion and 38 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 19 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of treatment related adverse events (AEs). (time frame: Day 0-114). 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 NCT04269538, 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 19 Oct 2023; AzTrials last refreshed its copy on 8 Nov 2026.