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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Inflammatory Bowel Disease

Treatments: Drug: Placebo; Drug: 450mg; Drug: 150mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT05107492

B7541013

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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12 participants in 2 patient groups

Cohort 1

Experimental group

Description:

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

Treatment:

Drug: 450mg

Drug: Placebo

Cohort 2

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: 150mg