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

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03146065
• Collaborator: (none)
• Enrollment: 79
• Location: 1
• Arms: 2
• Actual Duration (Months): 11.8
• Patients Per Site Per Month: 6.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Biological: PF-06730512; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 79 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Basic Science
• 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
• Actual Study Start Date: May 10, 2017
• Actual Primary Completion Date: May 3, 2018
• Actual Study Completion Date: May 3, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PF-06730512 Study Drug being used in the study	Biological: PF-06730512; Comparison of different dosages of PF-06730512 to Placebo
Placebo Comparator: Placebo Placebo for IV/SC administration	Drug: Placebo; Comparison of Placebo to different doses of PF-06730512

Outcome Measures

Primary Outcome Measures

1. 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 Treatment Emergent Treatment-Related Adverse Event(s)

2. Number of subjects with injection site reaction(s) [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 [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 [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 [Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose)]

   Number of subjects with ECG findings of potential clinical importance

Secondary Outcome Measures

1. Maximum Observed Plasma Concentration (Cmax) of PF-06730512 [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 [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 [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 [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 [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 [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 [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 [Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)]

   Terminal half-life, as permitted

9. Accumulation ratio (Rac), as permitted [Day 1 to approximately Day 113]

   Accumulation ratio (Rac), as permitted

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Clinical Research Unit	Brussels		Belgium	B-1070

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT03146065
• Other Study ID Numbers: C0221001; 2016-004493-18; FIH SAD/MAD
• First Posted: May 9, 2017
• Last Update Posted: May 22, 2018
• Last Verified: May 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of May 22, 2018