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Completed

NCT Number: NCT04543344

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

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.

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Key information

Conditions

Healthy

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Brussels Clinical Research Unit

Brussels, Bruxelles-capitale, Région de, B-1070, Belgium

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Recifercept

Drug

recifercept powder for solution for injection

Other names: PF-07256472

Placebo

Other

solution for injection

Primary outcomes

  1. 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).

  2. 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)

  3. 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

  4. 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

  5. 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.

  6. 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).

Secondary outcomes

  1. Incidence of Anti-drug antibodies (ADA)

    Time frame: 6 months post-dose

    Incidence of participants who are ADA positive

  2. Incidence of Neutralizing antibodies (NAb)

    Time frame: 6 months post-dose

    Incidence of participants who are NAb positive

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 10, 2020
Registry last updated
Jan 10, 2022

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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