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Completed

NCT Number: NCT02766621

Evaluation Of Safety, Tolerability And Pharmacokinetics Of Single And Multiple Doses Of Compound PF-06823859

The purpose of this study is to determine the safety, tolerability and pharmacokinetics of escalating single and multiple intravenous (IV) infusions and subcutaneous (SC) injections of PF 06823859 in healthy subjects.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy female subjects of non childbearing potential and male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG or clinical laboratory tests.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion criteria

  • History of active or latent tuberculosis (TB) regardless of treatment; positive Quantiferon - TB test.
  • Subjects with a history of autoimmune disorders.
  • Subjects with a history of or positive results for any of the following serological tests: Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb), anti Hepatitis C antibody (HCVAb) or human immunodeficiency virus (HIV).

Treatment and study plan

PF-06823859

Biological

Comparison of different dosages of PF-06823859 to placebo

Other names: Study drug

Placebo injection SC/IV

Drug

Comparison of Placebo to different doses of PF-06823859

Other names: Placebo

Primary outcomes

  1. Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs

    Time frame: Dosing through approximately Day 189

    Safety

Secondary outcomes

  1. Apparent Clearance (CL) of PF-06823859

    Time frame: Pre dose to approximately Day 189

    Pharmacokinetics

  2. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of PF-06823859

    Time frame: Pre dose to approximately Day 189

    Pharmacokinetics

  3. Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06823859

    Time frame: Pre dose to approximately Day 189

    Pharmacokinetics

  4. Number of Participants With Anti-Drug Antibody (ADA) to PF-06823859

    Time frame: Pre dose to approximately Day 189

    Immunogenicity

  5. Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of PF-06823859

    Time frame: Pre dose to approximately Day 189

    Pharmacokinetics

  6. Maximum Observed Plasma Concentration (Cmax) of PF-06823859

    Time frame: Pre dose to approximately Day 189

    Pharmacokinetics

  7. Plasma Decay Half-Life (t1/2)

    Time frame: Pre dose to approximately Day 189

    Pharmacokinetics

  8. Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06823859 administered subcutaneously

    Time frame: Pre dose to approximately Day 189

    Pharmacokinetics

  9. Volume of Distribution at Steady State (Vss) of PF-06823859

    Time frame: Pre dose to approximately Day 189

    Pharmacokinetics

  10. AUCtau (dose normalized)

    Time frame: Pre dose to approximately Day 189

    Pharmacokinetics

  11. C av of PF-06823859

    Time frame: Pre dose to approximately Day 189

    Pharmacokinetics

  12. Mean residence of time for PF-06823859

    Time frame: Pre dose to approximately Day 189

    Pharmacokinetics

  13. Maximum Observed Plasma Concentration (Cmax) dose normalized of PF-06823859

    Time frame: Pre dose to approximately Day 189

    Pharmacokinetics

  14. bioavailability of PF-06823859 subcutaneous doses compared to intravenous doses of PF-06823859

    Time frame: Pre dose to approximately Day 189

    Pharmacokinetics

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Phase 1, Randomized, Double-blind, Third-party Open Placebo-controlled, Dose Escalating Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Single And Multiple Intravenous And Subcutaneous Doses Of Pf-06823859 In Healthy Subjects

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 10, 2016
Registry last updated
Nov 17, 2017

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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