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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Inflammatory Bowel Disease

Intervention / Treatment
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* Drug: 450mg
* Drug: 150mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>12 participants will be randomly assigned at an allocation ratio of 3:1 to the active treatment 450mg and placebo arms. | Drug: 450mg<br>* following a single subcutaneous dose of PF-06480605 450 mg<br>Drug: Placebo<br>* following a single subcutaneous dose of placebo<br>|
| Experimental: Cohort 2<br>12 participants will be randomly assigned at an allocation ratio of 3:1 to the active treatment 150mg and placebo arms. | Drug: 150mg<br>* following a single subcutaneous dose of PF-06480605 150 mg<br>Drug: Placebo<br>* following a single subcutaneous dose of placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) |  | Day 1 to Day 114 | 
| Time to Reach Maximum Observed Plasma Concentration (Tmax) |  | Day 1 to Day 114 | 
| Area Under the Curve From Time Zero to End of Dosing Interval (AUC 14 days)) |  | Day 1 to Day 14 | 
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) |  | Day 1 to Day 114 | 
| Plasma Decay Half-Life (t1/2) |  | Day 1 to Day 114 | 
| Number of Participants with Adverse Events (AEs) |  | Day 1 to Day 114 | 
| Number of Participants with abnormal vital signs |  | Day 1 to Day 114 | 
| Number of Participants with abnormal 12 lead electrocardiograms |  | Day 1 to Day 114 | 
| Number of Participants with abnormal physical examination findings |  | Day 1 to Day 114 | 
| Number of Participants with abnormal clinical safety laboratory measurements |  | Day 1 to Day 114 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) |  | Day 1 to Day 114 | 
| Cmax(dn) |  | Day 1 to Day 114 | 
| AUCinf(dn) |  | Day 1 to Day 114 | 
| Apparent Volume of Distribution (Vz/F) |  | Day 1 to Day 114 | 
| Apparent Oral Clearance (CL/F) |  | Day 1 to Day 114 | 
| Incidence of the development of ADA and NAb. |  | Day 1 to Day 114 | 
| Total sTL1A protein concentration in serum. |  | Day 1 to Day 114 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IBD, PK