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

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03146065
• Other study ID #: C0221001
• Secondary ID: 2016-004493-18FI
• Status: Completed
• Phase: Phase 1
• Start date: May 10, 2017
• Est. completion date: May 3, 2018

Study information

• Verified date: May 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: May 3, 2018
• Est. primary completion date: May 3, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Biological:
• PF-06730512
Comparison of different dosages of PF-06730512 to Placebo

Drug:
• Placebo
Comparison of Placebo to different doses of PF-06730512

Locations

Country	Name	City	State
Belgium	Pfizer Clinical Research Unit	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With Treatment Emergent Treatment-Related Adverse Event(s)	Number of Subjects With Treatment Emergent Treatment-Related Adverse Event(s)	Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose)
Primary	Number of subjects with injection site reaction(s)	Number of subjects with injection site reaction(s)	Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose)
Primary	Number of subjects with laboratory test findings of potential clinical importance	Number of subjects with laboratory test findings of potential clinical importance	Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose)
Primary	Number of subjects with vital signs findings of potential clinical importance	Number of subjects with vital signs findings of potential clinical importance	Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose)
Primary	Number of subjects with ECG findings of potential clinical importance	Number of subjects with ECG findings of potential clinical importance	Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose)
Secondary	Maximum Observed Plasma Concentration (Cmax) of PF-06730512	Maximum Observed Plasma Concentration (Cmax) of PF-06730512	Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)
Secondary	Time to Reach Maximum Observed Concentration (Tmax) of PF-06730512	Time to Reach Maximum Observed Concentration (Tmax) of PF-06730512	Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)
Secondary	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06730512	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06730512	Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)
Secondary	Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] of PF-06730512, as permitted	Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] of PF-06730512, as permitted	Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)
Secondary	Clearance (CL) or Apparent Clearance (CL/F) of PF-06730512, as permitted	Clearance (CL) or Apparent Clearance (CL/F) of PF-06730512, as permitted	Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)
Secondary	Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06730512	Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06730512	Day 1 to approximately Day 113
Secondary	Apparent Volume of Distribution of PF-06730512, as permitted	Apparent Volume of Distribution of PF-06730512, as permitted	Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)
Secondary	Terminal half-life, as permitted	Terminal half-life, as permitted	Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)
Secondary	Accumulation ratio (Rac), as permitted	Accumulation ratio (Rac), as permitted	Day 1 to approximately Day 113
Secondary	Minimum observed concentration during the dosing interval (Cmin)	Minimum observed concentration during the dosing interval (Cmin)	Day 1 to approximately Day 113
Secondary	Incidence of the development of anti-drug antibody (ADA) and neutralizing antibody (NAb)	Incidence of the development of anti-drug antibody (ADA) and neutralizing antibody (NAb)	Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)

External Links

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