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

NCT03146065 | Completed Phase 1 FDA Drug

• 3 other identifiers: C02210012016-004493-18FIH SAD/MAD
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (11)

• Maximum Observed Plasma Concentration (Cmax) of PF-06730512

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

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

  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

  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

  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

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

Study Arms (2)

PF-06730512

EXPERIMENTAL

Study Drug being used in the study

Biological: PF-06730512

Placebo

PLACEBO COMPARATOR

Placebo for IV/SC administration

Drug: Placebo

Interventions

PF-06730512 BIOLOGICAL

Comparison of different dosages of PF-06730512 to Placebo

PF-06730512

Placebo DRUG

Comparison of Placebo to different doses of PF-06730512

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit

Brussels, B-1070, Belgium

Location

Related Publications (1)

• 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.

  PMID: 34369667 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.
• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

PF-06730512

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: May 9, 2017
• Study Start: May 10, 2017
• Primary Completion: May 3, 2018
• Study Completion: May 3, 2018
• Last Updated: May 22, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)