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Singe Dose Study of PF- 06946860 in Healthy Adult Japanese Participants

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ClinicalTrials.gov Identifier: NCT03974776
Recruitment Status : Recruiting
First Posted : June 5, 2019
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of PF-06946860 in healthy adult Japanese participants following single dose administration.

Condition or disease Intervention/treatment Phase
Healthy Biological: PF-06946860 Other: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: A PHASE 1, RANDOMIZED, DOUBLE BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SINGLE-DOSE, SUBCUTANEOUS ADMINISTRATION OF PF-06946860 TO HEALTHY ADULT JAPANESE PARTICIPANTS
Actual Study Start Date : July 8, 2019
Estimated Primary Completion Date : January 8, 2020
Estimated Study Completion Date : January 8, 2020

Arm Intervention/treatment
Experimental: PF-06946860
Single subcutaneous administration of PF-06946860
Biological: PF-06946860
PF-06946860 administered subcutaneously

Placebo Comparator: Placebo
Single subcutaneous administration of placebo
Other: Placebo
Placebo administered subcutaneously




Primary Outcome Measures :
  1. Incidence of participants experiencing AE [ Time Frame: Up to 20 weeks post-dose ]

Secondary Outcome Measures :
  1. Maximum Observed PF-06946860 Concentration (Cmax) [ Time Frame: Up to 20 weeks post-dose ]
  2. Area Under the Curve From Time Zero to Last Quantifiable PF-06946860 Concentration (AUClast) [ Time Frame: Up to 20 weeks post-dose ]
  3. Time to Reach Maximum Observed PF-06946860 Concentration (Tmax) [ Time Frame: Up to 20 weeks post-dose ]
  4. PF-06946860 Half-Life (t1/2) [ Time Frame: Up to 20 weeks post-dose, as data permit ]
    Time measured for the PF-06946860 concentration to decrease by one half.

  5. Incidence of development of ADA, and if necessary NAb, against PF-06946860 [ Time Frame: Up to 20 weeks post-dose, as data permit ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Key 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
  • Body mass index (BMI) within 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb)
  • Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study
  • Subjects enrolling as Japanese must have four biologically Japanese grandparents born in Japan.

Key Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing.
  • History of allergic reactions to diagnostic or therapeutic protein or human albumin.
  • History of recurrent infections or active infection within 28 days of screening.
  • Exposure to live vaccines within 28 days of screening.
  • History of regular alcohol consumption or positive drug test
  • Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of IP (whichever is longer).
  • Fertile male subjects who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for at least 28 days after the last dose.
  • Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974776


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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United States, California
Anaheim Clinical Trials LLC-Clinical Research Recruiting
Anaheim, California, United States, 92801
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03974776     History of Changes
Other Study ID Numbers: C3651002
FIP ( Other Identifier: Alias Study Number )
Japanese Ph1 ( Other Identifier: Alias Study Number )
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No