Inflammatory Bowel DiseasePhase 1NCT05107492
Evaluation of the Pharmacokinetics, Safety and Tolerability of Single Dose of PF-06480605 in Chinese Healthy Participants
A Phase 1 study testing 450mg and 150mg in people with Inflammatory Bowel Disease, run by Pfizer at 1 site in China.
Trial summary
This is a Phase 1, single-center, randomized, double-blind, third-party open (ie, participant blind, investigator blind and sponsor open), placebo controlled study to investigate PK, safety, tolerability, immunogenicity, and PD of PF 06480605 following a single subcutaneous dose of PF-06480605 450 mg and 150 mg (if… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Disease
- What is being tested?
- 450mg and 150mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 19 Nov 2021to 9 Apr 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female participants must be 18 to 45 years of age, inclusive, at the time of signing the ICD.
- Male and female Chinese participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital sign and 12-lead ECG
- BMI of 19 to 27 kg/m2; and a total body weight >50 kg.
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 HIV infection, hepatitis B, hepatitis C or syphilis; positive testing for HIV, hepatitis B, HCVAb or serological reaction of syphilis.
- 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 TB or active or latent or inadequately treated infection.
- Recent exposure to live vaccines within 28 days of the screening visit.
- A positive pregnancy test.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
Official title: A PHASE 1, RANDOMIZED, DOUBLE-BLIND, THIRD-PARTY OPEN, PLACEBO-CONTROLLED STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY FOLLOWING SINGLE SUBCUTANEOUS DOSE OF PF-06480605 IN CHINESE HEALTHY PARTICIPANTS
This is a Phase 1, single-center, randomized, double-blind, third-party open (ie, participant blind, investigator blind and sponsor open), placebo controlled study to investigate PK, safety, tolerability, immunogenicity, and PD of PF 06480605 following a single subcutaneous dose of PF-06480605 450 mg and 150 mg (if needed) in Chinese healthy adult participants.
- Conditions
- Inflammatory Bowel Disease
- Being tested
- 450mg, 150mg, Placebo
- Keywords
- IBD, PK
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
450mgDrug
following a single subcutaneous dose of PF-06480605 450 mg
150mgDrug
following a single subcutaneous dose of PF-06480605 150 mg
PlaceboDrug
following a single subcutaneous dose of placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 12 participants will be randomly assigned at an allocation ratio of 3:1 to the active treatment 450mg and placebo arms. Receives: Drug: 450mg; Drug: Placebo |
| Cohort 2 | Experimental | 12 participants will be randomly assigned at an allocation ratio of 3:1 to the active treatment 150mg and placebo arms. Receives: Drug: 150mg; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Concentration (Cmax) of PF-06480605
Cmax is the maximum observed plasma concentration.
Measured: At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1
Time for Cmax (Tmax) of PF-06480605
Tmax is the time for Cmax.
Measured: At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1
Area Under the Curve From Time 0 to End of Dosing Interval (AUC14day) of PF-06480605
AUC14day is area under the curve from time 0 to end of dosing interval (Day 14, 336 hours).
Measured: At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, and 336 hours post dose on Day 1
Area Under the Plasma Concentration Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06480605
AUCinf is area under the plasma concentration time profile from time 0 extrapolated to infinite time.
Measured: At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1
Terminal Half-life (t1/2) of PF-06480605
t1/2 is the terminal half-life (time required for the plasma concentration to decline by 50%)
Measured: At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1
Secondary outcomes (10)
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An 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. A serious AE (SAE) was defined as any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; or other serious situations such as important medical events. TEAEs were events between first dose of study drug and before the end of study (up to follow-up visits). AEs presented below were TEAEs. The investigator was required to use clinical judgment to assess the potential relationship between investigational product and each AE, to define an treatment-related AE.
Measured: Day 1 to Day 114
Number of Participants With Change From Baseline in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria
Vital signs abnormalities included: supine diastolic blood pressure (BP) increase and decrease from BL of >=20mmHg or absolute value <50mmHg; systolic BP increase and decrease from BL of >=30mmHg or absolute value <90mmHg; pulse rate <40 or >120bpm.
Measured: From Baseline (BL) to Day 114
Number of Participants With Change From Baseline in Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria
ECG assessments included PR, QT, and QTc intervals and QRS complex. ECG abnormalities included PR interval BL >200msec and max >=25% increase from BL, or BL <=200msec and max >=50% increase from BL, or absolute value >=300msec; QRS interval percent change from BL >=50% or absolute value >=140msec, QTcF change from BL >=30msec, or absolute value >450msec.
Measured: From BL to Day 114
Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Safety laboratory assessments included clinical chemistry, hematology, urinalysis, and other tests. Abnormality was determined at the investigator's discretion. Laboratory test abnormalities reported by at least 1 participant are reported in this outcome measure.
Measured: From BL to Day 114
Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06480605
AUClast is area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration
Measured: At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1
Apparent Volume of Distribution (Vz/F) of PF-06480605
Vz/F is the apparent volume of distribution, defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Measured: At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1
Apparent Oral Clearance (CL/F) of PF-06480605
CL/F is the apparent oral clearance, which is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Measured: At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1
Number of Participants With Positivie Anti-drug Antibody (ADA) Against PF-06480605
Summary of ADA incidence by visit is presented. ADA positive was defined as titer >=60.
Measured: On Days 1 (prior to dose), 15, 29, 57, 85 and 114
Number of Participants With Neutralizing Antibody (NAb) Against PF-06480605
Summary of NAb incidence by visit is presented. NAb positive was defined as titer >=5. ADA-positive participants (defined as titer >=60) were analyzed for NAb.
Measured: On Days 1 (prior to dose), 15, 29, 57, 85 and 114
Total Soluble Tumor Necrosis Factor Like Ligand 1A (sTL1A) Protein Concentration in Serum
The total sTL1A protein concentration in serum is summarized by time.
Measured: On Days 1 (prior to dose), 2, 5, 15, 29, 57, 85 and 114
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start19 Nov 2021
- Primary completion9 Apr 2022
- Study completion9 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05107492
- Sponsor's protocol ID
- B7541013
- Status last verified
- Sep 2023
- First submitted
- 3 Nov 2021
- Last updated
- 21 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. 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 STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY FOLLOWING SINGLE SUBCUTANEOUS DOSE OF PF-06480605 IN CHINESE HEALTHY PARTICIPANTS
- ClinicalTrials.gov ID
- NCT05107492
- Acronym / sponsor ID
- B7541013
- Conditions
- Inflammatory Bowel Disease
- Keywords
- IBD, PK
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 19 Nov 2021 (actual)
- Primary completion
- 9 Apr 2022 (actual)
- Study completion
- 9 Apr 2022 (actual)
- First posted
- 4 Nov 2021 (actual)
- Results
- Posted 21 Mar 2024
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, single-center, randomized, double-blind, third-party open (ie, participant blind, investigator blind and sponsor open), placebo controlled study to investigate PK, safety, tolerability, immunogenicity, and PD of PF 06480605 following a single subcutaneous dose of PF-06480605 450 mg and 150 mg (if needed) in Chinese healthy adult participants.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: 450mg, Drug: Placebo12 participants will be randomly assigned at an allocation ratio of 3:1 to the active treatment 450mg and placebo arms. |
| Cohort 2 | Experimental | Drug: 150mg, Drug: Placebo12 participants will be randomly assigned at an allocation ratio of 3:1 to the active treatment 150mg and placebo arms. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male and female participants must be 18 to 45 years of age, inclusive, at the time of signing the ICD.
- Male and female Chinese participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital sign and 12-lead ECG
- BMI of 19 to 27 kg/m2; and a total body weight >50 kg.
Key exclusion criteria (8 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 HIV infection, hepatitis B, hepatitis C or syphilis; positive testing for HIV, hepatitis B, HCVAb or serological reaction of syphilis.
- 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.
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 |
|---|---|---|
| 450mgfollowing a single subcutaneous dose of PF-06480605 450 mg | Drug | Cohort 1 |
| 150mgfollowing a single subcutaneous dose of PF-06480605 150 mg | Drug | Cohort 2 |
| Placebofollowing a single subcutaneous dose of placebo | Drug | Cohort 1, Cohort 2 |
Primary outcome
Maximum Observed Concentration (Cmax) of PF-06480605
Time frame: At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1
Cmax is the maximum observed plasma concentration.
Time for Cmax (Tmax) of PF-06480605
Time frame: At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1
Tmax is the time for Cmax.
Area Under the Curve From Time 0 to End of Dosing Interval (AUC14day) of PF-06480605
Time frame: At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, and 336 hours post dose on Day 1
AUC14day is area under the curve from time 0 to end of dosing interval (Day 14, 336 hours).
Area Under the Plasma Concentration Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06480605
Time frame: At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1
AUCinf is area under the plasma concentration time profile from time 0 extrapolated to infinite time.
Terminal Half-life (t1/2) of PF-06480605
Time frame: At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1
t1/2 is the terminal half-life (time required for the plasma concentration to decline by 50%)
10 secondary outcomes
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Day 1 to Day 114
Number of Participants With Change From Baseline in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria
Time frame: From Baseline (BL) to Day 114
Number of Participants With Change From Baseline in Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria
Time frame: From BL to Day 114
Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Time frame: From BL to Day 114
Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06480605
Time frame: At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1
Apparent Volume of Distribution (Vz/F) of PF-06480605
Time frame: At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1
Apparent Oral Clearance (CL/F) of PF-06480605
Time frame: At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1
Number of Participants With Positivie Anti-drug Antibody (ADA) Against PF-06480605
Time frame: On Days 1 (prior to dose), 15, 29, 57, 85 and 114
Number of Participants With Neutralizing Antibody (NAb) Against PF-06480605
Time frame: On Days 1 (prior to dose), 15, 29, 57, 85 and 114
Total Soluble Tumor Necrosis Factor Like Ligand 1A (sTL1A) Protein Concentration in Serum
Time frame: On Days 1 (prior to dose), 2, 5, 15, 29, 57, 85 and 114
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 450mg and 150mg in people with Inflammatory Bowel Disease, run by Pfizer at 1 site in China.
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 3 inclusion and 8 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 21 Mar 2024. 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 China. 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. 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 21 Mar 2024). 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?
Maximum Observed Concentration (Cmax) of PF-06480605 (time frame: At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Mar 2024.