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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-19

Study Completion Date

2022-04-09

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.

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Detailed Description

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Conditions

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Inflammatory Bowel Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1

12 participants will be randomly assigned at an allocation ratio of 3:1 to the active treatment 450mg and placebo arms.

Group Type EXPERIMENTAL

450mg

Intervention Type DRUG

following a single subcutaneous dose of PF-06480605 450 mg

Placebo

Intervention Type DRUG

following a single subcutaneous dose of placebo

Cohort 2

12 participants will be randomly assigned at an allocation ratio of 3:1 to the active treatment 150mg and placebo arms.

Group Type EXPERIMENTAL

150mg

Intervention Type DRUG

following a single subcutaneous dose of PF-06480605 150 mg

Placebo

Intervention Type DRUG

following a single subcutaneous dose of placebo

Interventions

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450mg

following a single subcutaneous dose of PF-06480605 450 mg

Intervention Type DRUG

150mg

following a single subcutaneous dose of PF-06480605 150 mg

Intervention Type DRUG

Placebo

following a single subcutaneous dose of placebo

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes