Study To Evaluate The Pharmacokinetic, Safety And Tolerability Of Single Or Multiple Subcutaneous Doses of Recifercept

NCT04543344

Last updated date
Study Location
Brussels Clinical Research Unit
Brussels, Bruxelles-capitale, Région DE, B-1070, Belgium
Contact
1-800-718-1021

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1-800-718-1021

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male participants and female participants of nonchildbearing potential

- Participants who are overtly healthy

- Capable of giving signed informed consent

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or
allergic disease


- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more
within 60 days prior to dosing

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study To Evaluate The Pharmacokinetic, Safety And Tolerability Of Single Or Multiple Subcutaneous Doses of Recifercept
Official Title  ICMJE A Phase 1, Randomized, Parallel-Group Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Single or Multiple Subcutaneous Doses of Lyophilized Formulation of Recifercept in Healthy Participants
Brief Summary This will be a single center, randomized, parallel group, repeated dose study of recifercept (Cohort 1 and Cohort 2) or placebo (only in Cohort 1) in approximately 18 healthy participants, using 2 cohorts (N = 9) at two dose levels of recifercept.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Only cohort 1 of the study is blinded.
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Recifercept
    recifercept powder for solution for injection
    Other Name: PF-07256472
  • Other: Placebo
    solution for injection
Study Arms  ICMJE
  • Experimental: Low Dose
    Repeated multiple doses
    Intervention: Drug: Recifercept
  • Placebo Comparator: placebo
    Repeated multiple doses
    Intervention: Other: Placebo
  • Experimental: High Dose
    Repeated multiple doses
    Intervention: Drug: Recifercept
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 4, 2020)
18
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 20, 2021
Estimated Primary Completion Date April 20, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male participants and female participants of nonchildbearing potential
  • Participants who are overtly healthy
  • Capable of giving signed informed consent

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease
  • Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 21 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04543344
Other Study ID Numbers  ICMJE C4181004
2020-000545-14 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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/d….
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP