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Trial record 1 of 1 for:    NCT04543344
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Study To Evaluate The Pharmacokinetic, Safety And Tolerability Of Single Or Multiple Subcutaneous Doses of Recifercept

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ClinicalTrials.gov Identifier: NCT04543344
Recruitment Status : Recruiting
First Posted : September 10, 2020
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE September 4, 2020
First Posted Date  ICMJE September 10, 2020
Last Update Posted Date October 20, 2020
Actual Study Start Date  ICMJE September 17, 2020
Estimated Primary Completion Date April 20, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2020)
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) [ Time Frame: 0, 2, 4, 6, 12, 24, 48, 72, 120, 168, 216, 312 and 504 hours post-dose ]
    AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).
  • Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) [ Time Frame: 0, 2, 4, 6, 12, 24, 48 and 72 hours post-dose ]
    Area under the concentration curve from time 0 to end of dosing interval (AUCtau)
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0, 2, 4, 6, 12, 24, 48, 72, 120, 168, 216, 312 and 504 hours post-dose ]
    Maximum Observed Plasma Concentration directly from data
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0, 2, 4, 6, 12, 24, 48, 72, 120, 168, 216, 312 and 504 hours post-dose ]
    Time to reach Cmax
  • Plasma Decay Half-Life (t1/2) [ Time Frame: 0, 2, 4, 6, 12, 24, 48, 72, 120, 168, 216, 312 and 504 hours post-dose ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
  • Accumulation Ratio (Rac) [ Time Frame: 0, 2, 4, 6, 12, 24, 48 and 72 hours post-dose ]
    Accumulation ratio was calculated as, Rac obtained from Area Under the Concentration Time Curve (AUC) from time 0-t (Day X) divided by AUC from time 0-t (Day 1).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2020)
  • Incidence of Anti-drug antibodies (ADA) [ Time Frame: 6 months post-dose ]
    Incidence of participants who are ADA positive
  • Incidence of Neutralizing antibodies (NAb) [ Time Frame: 6 months post-dose ]
    Incidence of participants who are NAb positive
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
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/data_requests.
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
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