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Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Recifercept in Healthy Chinese Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05061277
Recruitment Status : Withdrawn (Pfizer has decided to cancel study C4181006 due to strategic considerations. This decision is not due to any specific reasons or requests from any regulatory authorities. No participants have been enrolled in this study.)
First Posted : September 29, 2021
Last Update Posted : April 18, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
The purpose of this study is to evaluate the pharmacokinetic (PK), safety, tolerability and immunogenicity of a single subcutaneous (SC) dose of the lyophilized formulation of recifercept in healthy Chinese participants.

Condition or disease Intervention/treatment Phase
Healthy Drug: Recifercept Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A PHASE 1, OPEN-LABEL, SINGLE SUBCUTANEOUS DOSE STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF LYOPHILIZED FORMULATION OF RECIFERCEPT IN HEALTHY CHINESE PARTICIPANTS
Estimated Study Start Date : October 25, 2023
Estimated Primary Completion Date : December 12, 2023
Estimated Study Completion Date : June 16, 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: Recifercept
A 300 mg single subcutaneous (SC) dose of recifercept for the treatment phase of study
 Drug: Recifercept
A lyophilized powder for solution for injection
Other Name: PF-07256472


Outcome Measures
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Primary Outcome Measures :
  1. Maximum Observed Concentration (Cmax) [ Time Frame: 0, 2, 4, 6, 12, 24, 48, 72, 120, 168, 216, 264, 312, 504 hours post-dose ]
  2. Time for Cmax (Tmax) [ Time Frame: 0, 2, 4, 6, 12, 24, 48, 72, 120, 168, 216, 264, 312, 504 hours post-dose ]
  3. Area Under the Serum Concentration Time Profile from Time Zero to 168 hrs (AUC0-168) [ Time Frame: 0, 2, 4, 6, 12, 24, 48, 72, 120, 168 hours post-dose ]
  4. Area Under the Serum Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) [ Time Frame: 0, 2, 4, 6, 12, 24, 48, 72, 120, 168, 216, 264, 312, 504 hours post-dose ]
  5. Area Under the Serum Concentration Time Profile from Time 0 Extrapolated to Infinite Time (AUCinf) [ Time Frame: 0, 2, 4, 6, 12, 24, 48, 72, 120, 168, 216, 264, 312, 504 hours post-dose ]
  6. Terminal Elimination Half-Life (t½) [ Time Frame: 0, 2, 4, 6, 12, 24, 48, 72, 120, 168, 216, 264, 312, 504 hours post-dose ]
  7. Apparent Clearance (CL/F) [ Time Frame: 0, 2, 4, 6, 12, 24, 48, 72, 120, 168, 216, 264, 312, 504 hours post-dose ]
  8. Apparent Volume of Distribution (Vz/F) [ Time Frame: 0, 2, 4, 6, 12, 24, 48, 72, 120, 168, 216, 264, 312, 504 hours post-dose ]

Secondary Outcome Measures :
  1. Incidence of Participants With Positive Anti-Drug Antibodies (ADA) [ Time Frame: 0, 168, 312, 504, 672 hours post-dose and maybe months 4 and/or month 7 post-dose ]
  2. Incidence of Participants With Positive Neutralizing Antibodies (NAb) [ Time Frame: Maybe 0, 168, 312, 504, 672 hours post-dose and maybe months 4 and/or month 7 post-dose ]
  3. Incidence of Adverse Events (AEs) [ Time Frame: Since inform consent form (ICD) is signed till up to about Day 29, or maybe till Month 4 or Month 7 post-dose, or when terminated/withdrawal from study ]
  4. Incidence of Clinical Laboratory Test Abnormalitiests [ Time Frame: Baseline to approximately Day 22, or up to approximately Month 4 or Month 7 post-dose, or when terminated/withwal from study ]
  5. Incidence of Participants With Clinically Relevant Changes in Vital Signs [ Time Frame: Baseline, within -3 hours pre-dose, and at 4, 24, 48, 72 hours post-dose, or up to approximately Month 4 or Month 7 post-dose, or when terminated/withdrawal from study ]
  6. Incidence of Participants With Clinically Relevant Changes in 12-lead Electrocardiogram (ECG) [ Time Frame: Baseline, within -3 hours pre-dose, and at 4, 24, 48, 72 hours post-dose, or up to approximately Month 4 or Month 7 post-dose, or when terminated/withdrawal from study ]
  7. Incidence of Participants With Infusion Site Reactions [ Time Frame: From time of signing inform concent form (ICD) to approximately Day 29, or up to approximately Month 4 or Month 7 post-dose, or when terminated/withdrawal from study ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Chinese male and female participants of nonchildbearing potential must be 21 to 55 years of age, inclusive at the time of signing the ICD.
  • Chinese male and female participants who are overtly healthy as determined by medical evaluation.
  • Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
  • Participants must be of Chinese ethnicity (individuals currently residing in mainland China who were born in China and have both parents of Chinese descent).
  • Body mass index (BMI) of 19.0 to 27.5 kg/m2; and a total body weight >50 kg and ≤ 120 kg.
  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.

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).
  • Any condition possibly affecting drug absorption (eg, skin inflammation at infusion site, acne, rash, scarring, tattoos, erythema, sunburn, deep tanning, etc).
  • History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), or serological reaction of syphilis. Prior hepatitis B vaccination is allowed.
  • Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
  • Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half lives (whichever is longer) prior to the dose of study intervention.
  • Previous administration with an investigational drug/medical device within 30 days (or as determined by the local requirement) or 5 half lives preceding the dose of study intervention used in this study (whichever is longer).
  • A positive urine drug test.
  • Screening supine blood pressure (BP) ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest. Pulse rate > 100 beats/minute. Oral temperature (or ear temperature) > 37.5 ℃.
  • Baseline 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, baseline corrected QT (QTc) interval >450 msec, complete LBBB, signs of an acute or indeterminate age myocardial infarction, ST T interval changes suggestive of myocardial ischemia, second or third degree AV block, or serious bradyarrhythmias or tachyarrhythmias).

  • Participants with ANY of the following abnormalities in clinical laboratory tests at Screening, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary:

    • aspartate aminotransferase (AST) or aspartate aminotransferase (ALT) level ≥ 1.5 × upper limit of normal (ULN);
    • Total bilirubin level ≥1.5 × ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is≤ ULN.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05061277


Locations
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China, Shanghai
Huashan Hospital Fudan University
Shanghai, Shanghai, China, 200040
Huashan Hospital Fudan University
Shanghai, Shanghai, China, 201107
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05061277    
Other Study ID Numbers: C4181006
First Posted: September 29, 2021    Key Record Dates
Last Update Posted: April 18, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes