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Completed

NCT Number: NCT05107492

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

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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Key information

Conditions

Inflammatory Bowel Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

450mg

Drug

following a single subcutaneous dose of PF-06480605 450 mg

150mg

Drug

following a single subcutaneous dose of PF-06480605 150 mg

Placebo

Drug

following a single subcutaneous dose of placebo

Primary outcomes

  1. Maximum Observed Concentration (Cmax) of PF-06480605

    Time frame: 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

    Cmax is the maximum observed plasma concentration.

  2. Time for Cmax (Tmax) of PF-06480605

    Time frame: 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

    Tmax is the time for Cmax.

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

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

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

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

    Time frame: 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

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

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

    Time frame: 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

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

Secondary outcomes

  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Time frame: Day 1 to Day 114

    An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious AE (SAE) was defined as any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; or other serious situations such as important medical events. TEAEs were events between first dose of study drug and before the end of study (up to follow-up visits). AEs presented below were TEAEs. The investigator was required to use clinical judgment to assess the potential relationship between investigational product and each AE, to define an treatment-related AE.

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

    Time frame: From Baseline (BL) to Day 114

    Vital signs abnormalities included: supine diastolic blood pressure (BP) increase and decrease from BL of >=20mmHg or absolute value <50mmHg; systolic BP increase and decrease from BL of >=30mmHg or absolute value <90mmHg; pulse rate <40 or >120bpm.

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

    Time frame: From BL to Day 114

    ECG assessments included PR, QT, and QTc intervals and QRS complex. ECG abnormalities included PR interval BL >200msec and max >=25% increase from BL, or BL <=200msec and max >=50% increase from BL, or absolute value >=300msec; QRS interval percent change from BL >=50% or absolute value >=140msec, QTcF change from BL >=30msec, or absolute value >450msec.

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

    Time frame: From BL to Day 114

    Safety laboratory assessments included clinical chemistry, hematology, urinalysis, and other tests. Abnormality was determined at the investigator's discretion. Laboratory test abnormalities reported by at least 1 participant are reported in this outcome measure.

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

    Time frame: 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

    AUClast is area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration

  6. Apparent Volume of Distribution (Vz/F) of PF-06480605

    Time frame: 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

    Vz/F is the apparent volume of distribution, defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.

  7. Apparent Oral Clearance (CL/F) of PF-06480605

    Time frame: 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

    CL/F is the apparent oral clearance, which is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

  8. Number of Participants With Positivie Anti-drug Antibody (ADA) Against PF-06480605

    Time frame: On Days 1 (prior to dose), 15, 29, 57, 85 and 114

    Summary of ADA incidence by visit is presented. ADA positive was defined as titer >=60.

  9. Number of Participants With Neutralizing Antibody (NAb) Against PF-06480605

    Time frame: On Days 1 (prior to dose), 15, 29, 57, 85 and 114

    Summary of NAb incidence by visit is presented. NAb positive was defined as titer >=5. ADA-positive participants (defined as titer >=60) were analyzed for NAb.

  10. Total Soluble Tumor Necrosis Factor Like Ligand 1A (sTL1A) Protein Concentration in Serum

    Time frame: On Days 1 (prior to dose), 2, 5, 15, 29, 57, 85 and 114

    The total sTL1A protein concentration in serum is summarized by time.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 4, 2021
Registry last updated
Mar 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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