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Singe Dose, First in Human Study of PF- 06946860 in Healthy Adult Subjects

Last updated on November 13, 2019

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Study Location
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, 06511 United States
Contact
800-254-6398
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT03599063
Pfizer
Completed
Singe Dose, First in Human Study of PF- 06946860 in Healthy Adult Subjects

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Descriptive Information
Brief Title  ICMJE Singe Dose, First in Human Study of PF- 06946860 in Healthy Adult Subjects
Official Title  ICMJE A PHASE 1, RANDOMIZED, DOUBLE BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, DOSE ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SINGLE-DOSE, SUBCUTANEOUS ADMINISTRATION OF PF 06946860 TO HEALTHY ADULT SUBJECTS
Brief SummaryThe purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of PF-06946860 in healthy adult subjects following single ascending doses This is the first clinical study of PF-06946860.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Biological: PF-06946860
    PF-06946860 administered subcutaneously
  • Other: Placebo
    Placebo, administered subcutaneously
Study Arms  ICMJE
  • Experimental: Cohort 1
    Single subcutaneous administration of PF-06946860 at planned dose level 0.1 mg, or placebo
    Interventions:
    • Biological: PF-06946860
    • Other: Placebo
  • Experimental: Cohort 2
    Single subcutaneous administration of PF-06946860 at planned dose level 0.3 mg, or placebo
    Interventions:
    • Biological: PF-06946860
    • Other: Placebo
  • Experimental: Cohort 3
    Single subcutaneous administration of PF-06946860 at planned dose level 1 mg, or placebo
    Interventions:
    • Biological: PF-06946860
    • Other: Placebo
  • Experimental: Cohort 4
    Single subcutaneous administration of PF-06946860 at planned dose level 3 mg, or placebo
    Interventions:
    • Biological: PF-06946860
    • Other: Placebo
  • Experimental: Cohort 5
    Single subcutaneous administration of PF-06946860 at planned dose level 10 mg, or placebo
    Interventions:
    • Biological: PF-06946860
    • Other: Placebo
  • Experimental: Cohort 6
    Single subcutaneous administration of PF-06946860 at planned dose level 30 mg, or placebo
    Interventions:
    • Biological: PF-06946860
    • Other: Placebo
  • Experimental: Cohort 7
    Single subcutaneous administration of PF-06946860 at planned dose level 100 mg, or placebo
    Interventions:
    • Biological: PF-06946860
    • Other: Placebo
  • Experimental: Optional: Cohort 8
    Optional: single subcutaneous administration of PF-06946860 at planned dose level 30 mg, or placebo in healthy Japanese subjects
    Interventions:
    • Biological: PF-06946860
    • Other: Placebo
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 6, 2019)
63
Original Estimated Enrollment  ICMJE
 (submitted: July 17, 2018)
77
Actual Study Completion Date  ICMJE September 18, 2019
Actual Primary Completion DateSeptember 18, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03599063
Other Study ID Numbers  ICMJE C3651001
FIH ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product:Yes
Studies a U.S. FDA-regulated Device Product:No
IPD Sharing Statement  ICMJE
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/da....
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 2019

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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