Back to resultsEvaluation of the Pharmacokinetics, Safety and Tolerability of Single Dose of PF-06480605 in Chinese Healthy Participants
Primary Purpose
Inflammatory Bowel Disease
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
450mg
150mg
Placebo
Sponsored by
About this trial
This is an interventional other trial for Inflammatory Bowel Disease focused on measuring IBD, PK
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Peking University Third Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cohort 1
Cohort 2
Arm Description
12 participants will be randomly assigned at an allocation ratio of 3:1 to the active treatment 450mg and placebo arms.
12 participants will be randomly assigned at an allocation ratio of 3:1 to the active treatment 150mg and placebo arms.
Outcomes
Primary Outcome Measures
Maximum Observed Plasma Concentration (Cmax)
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Area Under the Curve From Time Zero to End of Dosing Interval (AUC 14 days))
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
Plasma Decay Half-Life (t1/2)
Number of Participants with Adverse Events (AEs)
Number of Participants with abnormal vital signs
Number of Participants with abnormal 12 lead electrocardiograms
Number of Participants with abnormal physical examination findings
Number of Participants with abnormal clinical safety laboratory measurements
Secondary Outcome Measures
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Cmax(dn)
AUCinf(dn)
Apparent Volume of Distribution (Vz/F)
Apparent Oral Clearance (CL/F)
Incidence of the development of ADA and NAb.
Total sTL1A protein concentration in serum.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05107492
Brief Title
Evaluation of the Pharmacokinetics, Safety and Tolerability of Single Dose of PF-06480605 in Chinese Healthy Participants
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
November 19, 2021 (Actual)
Primary Completion Date
April 9, 2022 (Actual)
Study Completion Date
April 9, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 needed) in Chinese healthy adult participants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease
Keywords
IBD, PK
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
12 participants will be randomly assigned at an allocation ratio of 3:1 to the active treatment 450mg and placebo arms.
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
12 participants will be randomly assigned at an allocation ratio of 3:1 to the active treatment 150mg and placebo arms.
Intervention Type
Drug
Intervention Name(s)
450mg
Intervention Description
following a single subcutaneous dose of PF-06480605 450 mg
Intervention Type
Drug
Intervention Name(s)
150mg
Intervention Description
following a single subcutaneous dose of PF-06480605 150 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
following a single subcutaneous dose of placebo
Primary Outcome Measure Information:
Title
Maximum Observed Plasma Concentration (Cmax)
Time Frame
Day 1 to Day 114
Title
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame
Day 1 to Day 114
Title
Area Under the Curve From Time Zero to End of Dosing Interval (AUC 14 days))
Time Frame
Day 1 to Day 14
Title
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
Time Frame
Day 1 to Day 114
Title
Plasma Decay Half-Life (t1/2)
Time Frame
Day 1 to Day 114
Title
Number of Participants with Adverse Events (AEs)
Time Frame
Day 1 to Day 114
Title
Number of Participants with abnormal vital signs
Time Frame
Day 1 to Day 114
Title
Number of Participants with abnormal 12 lead electrocardiograms
Time Frame
Day 1 to Day 114
Title
Number of Participants with abnormal physical examination findings
Time Frame
Day 1 to Day 114
Title
Number of Participants with abnormal clinical safety laboratory measurements
Time Frame
Day 1 to Day 114
Secondary Outcome Measure Information:
Title
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time Frame
Day 1 to Day 114
Title
Cmax(dn)
Time Frame
Day 1 to Day 114
Title
AUCinf(dn)
Time Frame
Day 1 to Day 114
Title
Apparent Volume of Distribution (Vz/F)
Time Frame
Day 1 to Day 114
Title
Apparent Oral Clearance (CL/F)
Time Frame
Day 1 to Day 114
Title
Incidence of the development of ADA and NAb.
Time Frame
Day 1 to Day 114
Title
Total sTL1A protein concentration in serum.
Time Frame
Day 1 to Day 114
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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.
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=B7541013
Description
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Evaluation of the Pharmacokinetics, Safety and Tolerability of Single Dose of PF-06480605 in Chinese Healthy Participants
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