Clinical trial NCT03146065: Evaluation Of Safety, Tolerability And Pharmacokinetics Of Single And Multiple Doses Of PF-06730512
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2017-05-09
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Subjects With Treatment Emergent Treatment-Related Adverse Event(s)
timeFrame: Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose)
measure: Number of subjects with injection site reaction(s)
timeFrame: Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose)
measure: Number of subjects with laboratory test findings of potential clinical importance
timeFrame: Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose)
measure: Number of subjects with vital signs findings of potential clinical importance
timeFrame: Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose)
measure: Number of subjects with ECG findings of potential clinical importance
timeFrame: Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose)
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of PF-06730512
timeFrame: Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)
measure: Time to Reach Maximum Observed Concentration (Tmax) of PF-06730512
timeFrame: Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06730512
timeFrame: Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] of PF-06730512, as permitted
timeFrame: Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)
measure: Clearance (CL) or Apparent Clearance (CL/F) of PF-06730512, as permitted
timeFrame: Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)
measure: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06730512
timeFrame: Day 1 to approximately Day 113
measure: Apparent Volume of Distribution of PF-06730512, as permitted
timeFrame: Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)
measure: Terminal half-life, as permitted
timeFrame: Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)
measure: Accumulation ratio (Rac), as permitted
timeFrame: Day 1 to approximately Day 113
measure: Minimum observed concentration during the dosing interval (Cmin)
timeFrame: Day 1 to approximately Day 113
measure: Incidence of the development of anti-drug antibody (ADA) and neutralizing antibody (NAb)
timeFrame: Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Pfizer Clinical Research Unit
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Lim CN, Kantaridis C, Huyghe I, Gorman D, Berasi S, Sonnenberg GE. A Phase 1 first-in-human study of the safety, tolerability, and pharmacokinetics of the ROBO2 fusion protein PF-06730512 in healthy participants. Pharmacol Res Perspect. 2021 Aug;9(4):e00813. doi: 10.1002/prp2.813.