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

NCT05107492 | Completed Phase 1 Results

• 1 other identifier: B7541013
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Disease

Keywords

IBD; PK

Outcome Measures

Primary Outcomes (5)

• Maximum Observed Concentration (Cmax) of PF-06480605

  Cmax is the maximum observed plasma concentration.

  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

• Time for Cmax (Tmax) of PF-06480605

  Tmax is the time for Cmax.

  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

• Area Under the Curve From Time 0 to End of Dosing Interval (AUC14day) of PF-06480605

  AUC14day is area under the curve from time 0 to end of dosing interval (Day 14, 336 hours).

  At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, and 336 hours post dose on Day 1

• Area Under the Plasma Concentration Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06480605

  AUCinf is area under the plasma concentration time profile from time 0 extrapolated to infinite time.

  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

• Terminal Half-life (t1/2) of PF-06480605

  t1/2 is the terminal half-life (time required for the plasma concentration to decline by 50%)

  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 (10)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  Day 1 to Day 114

• Number of Participants With Change From Baseline in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria

  From Baseline (BL) to Day 114

• Number of Participants With Change From Baseline in Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria

  From BL to Day 114

• Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality)

  From BL to Day 114

• Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06480605

  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

Study Arms (2)

Cohort 1

EXPERIMENTAL

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

Drug: 450mg; Drug: Placebo

Cohort 2

EXPERIMENTAL

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

Drug: 150mg; Drug: Placebo

Interventions

450mg DRUG

following a single subcutaneous dose of PF-06480605 450 mg

Cohort 1

150mg DRUG

following a single subcutaneous dose of PF-06480605 150 mg

Cohort 2

Placebo DRUG

following a single subcutaneous dose of placebo

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: November 4, 2021
• Study Start: November 19, 2021
• Primary Completion: April 9, 2022
• Study Completion: April 9, 2022
• Last Updated: March 21, 2024
• Results First Posted: March 21, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)