Clinical trial NCT05107492: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Inflammatory Bowel Disease
Keywords: IBD
PK
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-11-04
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Maximum Observed Concentration (Cmax) of PF-06480605
timeFrame: 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
measure: Time for Cmax (Tmax) of PF-06480605
timeFrame: 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
measure: Area Under the Curve From Time 0 to End of Dosing Interval (AUC14day) of PF-06480605
timeFrame: At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, and 336 hours post dose on Day 1
measure: Area Under the Plasma Concentration Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06480605
timeFrame: 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
measure: Terminal Half-life (t1/2) of PF-06480605
timeFrame: 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:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: Day 1 to Day 114
measure: Number of Participants With Change From Baseline in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria
timeFrame: From Baseline (BL) to Day 114
measure: Number of Participants With Change From Baseline in Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria
timeFrame: From BL to Day 114
measure: Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality)
timeFrame: From BL to Day 114
measure: Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06480605
timeFrame: 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
measure: Apparent Volume of Distribution (Vz/F) of PF-06480605
timeFrame: 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
measure: Apparent Oral Clearance (CL/F) of PF-06480605
timeFrame: 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
measure: Number of Participants With Positivie Anti-drug Antibody (ADA) Against PF-06480605
timeFrame: On Days 1 (prior to dose), 15, 29, 57, 85 and 114
measure: Number of Participants With Neutralizing Antibody (NAb) Against PF-06480605
timeFrame: On Days 1 (prior to dose), 15, 29, 57, 85 and 114
measure: Total Soluble Tumor Necrosis Factor Like Ligand 1A (sTL1A) Protein Concentration in Serum
timeFrame: On Days 1 (prior to dose), 2, 5, 15, 29, 57, 85 and 114
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: