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Completed

NCT Number: NCT03146065

Evaluation Of Safety, Tolerability And Pharmacokinetics Of Single And Multiple Doses Of PF-06730512

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-06730512 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 Clinical Research Unit

Brussels, B-1070, Belgium

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy female subjects of nonchildbearing potential and/or 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 (BP) and pulse rate (PR) measurement, 12-lead electrocardiogram (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 lb).

Exclusion criteria

  • History of allergic reactions to diagnostic or therapeutic protein. History of recurrent infections or active infection within 28 days of screening.

Exposure to live vaccines within 28 days of screening.

  • History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody (HepBcAb), or hepatitis C antibody (HCVAb). As an exception, a positive hepatitis B surface antibody (HBsAb) finding as a result of subject vaccination is permissible.

Treatment and study plan

PF-06730512

Biological

Comparison of different dosages of PF-06730512 to Placebo

Placebo

Drug

Comparison of Placebo to different doses of PF-06730512

Primary outcomes

  1. Number of Subjects With Treatment Emergent Treatment-Related Adverse Event(s)

    Time frame: Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose)

    Number of Subjects With Treatment Emergent Treatment-Related Adverse Event(s)

  2. Number of subjects with injection site reaction(s)

    Time frame: Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose)

    Number of subjects with injection site reaction(s)

  3. Number of subjects with laboratory test findings of potential clinical importance

    Time frame: Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose)

    Number of subjects with laboratory test findings of potential clinical importance

  4. Number of subjects with vital signs findings of potential clinical importance

    Time frame: Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose)

    Number of subjects with vital signs findings of potential clinical importance

  5. Number of subjects with ECG findings of potential clinical importance

    Time frame: Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose)

    Number of subjects with ECG findings of potential clinical importance

Secondary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of PF-06730512

    Time frame: Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)

    Maximum Observed Plasma Concentration (Cmax) of PF-06730512

  2. Time to Reach Maximum Observed Concentration (Tmax) of PF-06730512

    Time frame: Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)

    Time to Reach Maximum Observed Concentration (Tmax) of PF-06730512

  3. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06730512

    Time frame: Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)

    Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06730512

  4. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] of PF-06730512, as permitted

    Time frame: Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)

    Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] of PF-06730512, as permitted

  5. Clearance (CL) or Apparent Clearance (CL/F) of PF-06730512, as permitted

    Time frame: Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)

    Clearance (CL) or Apparent Clearance (CL/F) of PF-06730512, as permitted

  6. Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06730512

    Time frame: Day 1 to approximately Day 113

    Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06730512

  7. Apparent Volume of Distribution of PF-06730512, as permitted

    Time frame: Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)

    Apparent Volume of Distribution of PF-06730512, as permitted

  8. Terminal half-life, as permitted

    Time frame: Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)

    Terminal half-life, as permitted

  9. Accumulation ratio (Rac), as permitted

    Time frame: Day 1 to approximately Day 113

    Accumulation ratio (Rac), as permitted

  10. Minimum observed concentration during the dosing interval (Cmin)

    Time frame: Day 1 to approximately Day 113

    Minimum observed concentration during the dosing interval (Cmin)

  11. Incidence of the development of anti-drug antibody (ADA) and neutralizing antibody (NAb)

    Time frame: Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)

    Incidence of the development of anti-drug antibody (ADA) and neutralizing antibody (NAb)

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1, Randomized, Double Blind, Sponsor-open, Placebo-controlled, First-in-human Trial To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Pf-06730512 After Single And Multiple Ascending Intravenous Infusion Or Subcutaneous Administration To Healthy Adult Subjects And An Open-label Evaluation In Healthy Japanese Subjects

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 9, 2017
Registry last updated
May 22, 2018

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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