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

Last updated on August 21, 2018

FOR MORE INFORMATION
Study Location
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, 06511 United States
Contact
1-800-718-1021
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
Recruiting
Singe Dose, First in Human Study of PF- 06946860 in Healthy Adult Subjects

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Singe Dose, First in Human Study of PF- 06946860 in Healthy Adult Subjects
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
The 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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Healthy
  • Biological: PF-06946860
    PF-06946860 administered subcutaneously
  • Other: Placebo
    Placebo, administered subcutaneously
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
77
Same as current
March 29, 2019
March 29, 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Not Provided
 
 
NCT03599063
C3651001
FIH ( Other Identifier: Alias Study Number )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2018

ICMJE     Data element required by the

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

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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