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Dose Escalation Study of PF-06741086 In Healthy Subjects

NCT ID: NCT02531815

Last Updated: 2016-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-07-31

Brief Summary

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This Phase 1 first-in-human single ascending dose study will be a randomized, double-blind, placebo-controlled investigation of the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06741086.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Cohort 1 (subcutaneous [SC]) PF-06741086, Placebo

Group Type EXPERIMENTAL

PF-06741086

Intervention Type BIOLOGICAL

PF-06741086, single dose, beginning with Cohort 1 dose level at 30 mg. Subsequent dose levels will be determined after data review of prior cohort(s)

Placebo

Intervention Type DRUG

Placebo for PF-06741086, single dose

Cohort 2 (SC) PF-06741086, Placebo

Group Type EXPERIMENTAL

PF-06741086

Intervention Type BIOLOGICAL

PF-06741086, single dose, beginning with Cohort 1 dose level at 30 mg. Subsequent dose levels will be determined after data review of prior cohort(s)

Placebo

Intervention Type DRUG

Placebo for PF-06741086, single dose

Cohort 3 (SC) PF-06741086, Placebo

Group Type EXPERIMENTAL

PF-06741086

Intervention Type BIOLOGICAL

PF-06741086, single dose, beginning with Cohort 1 dose level at 30 mg. Subsequent dose levels will be determined after data review of prior cohort(s)

Placebo

Intervention Type DRUG

Placebo for PF-06741086, single dose

Cohort 4 (Intravenous [IV]) PF-06741086, Placebo

Group Type EXPERIMENTAL

PF-06741086

Intervention Type BIOLOGICAL

PF-06741086, single dose, beginning with Cohort 1 dose level at 30 mg. Subsequent dose levels will be determined after data review of prior cohort(s)

Placebo

Intervention Type DRUG

Placebo for PF-06741086, single dose

Cohort 5 (IV) PF-06741086, Placebo

Group Type EXPERIMENTAL

PF-06741086

Intervention Type BIOLOGICAL

PF-06741086, single dose, beginning with Cohort 1 dose level at 30 mg. Subsequent dose levels will be determined after data review of prior cohort(s)

Placebo

Intervention Type DRUG

Placebo for PF-06741086, single dose

Cohort 6 (IV) PF-06741086, Placebo

Group Type EXPERIMENTAL

PF-06741086

Intervention Type BIOLOGICAL

PF-06741086, single dose, beginning with Cohort 1 dose level at 30 mg. Subsequent dose levels will be determined after data review of prior cohort(s)

Placebo

Intervention Type DRUG

Placebo for PF-06741086, single dose

Cohort 7 (IV) PF-06741086, Placebo

Group Type EXPERIMENTAL

PF-06741086

Intervention Type BIOLOGICAL

PF-06741086, single dose, beginning with Cohort 1 dose level at 30 mg. Subsequent dose levels will be determined after data review of prior cohort(s)

Placebo

Intervention Type DRUG

Placebo for PF-06741086, single dose

Cohort 8 (subcutaneous [SC]) PF-06741086

Group Type EXPERIMENTAL

PF-06741086

Intervention Type BIOLOGICAL

PF-06741086, single dose, beginning with Cohort 1 dose level at 30 mg. Subsequent dose levels will be determined after data review of prior cohort(s)

Interventions

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PF-06741086

PF-06741086, single dose, beginning with Cohort 1 dose level at 30 mg. Subsequent dose levels will be determined after data review of prior cohort(s)

Intervention Type BIOLOGICAL

Placebo

Placebo for PF-06741086, single dose

Intervention Type DRUG

Other Intervention Names

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saline placebo

Eligibility Criteria

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Inclusion Criteria

* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs) and 100 kg (220 lbs).

Exclusion Criteria

* Increased risk of thrombosis (coronary artery disease, hypercholesterolemia, diabetes)
* Use of nicotine/tobacco products
* Clotting disorders
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Clinical Research Unit

Brussels, , Belgium

Site Status

Countries

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Belgium

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7841001&StudyName=A%20Randomized%2C%20Double-blind%2C%20Sponsor-open%2C%20Placebo-controlled%2C%20Single%20Intravenous%20Or%20Subcutaneous%20Dose%20Escalation%20Study%20To%20Evaluate%20The%20Safety%2C%20Tolerability%2C%20Pharmacokinetics%2C%20And%20Pharmacodynamics%20Of%20Pf-06741086%20In%20Healthy%20Subjects%20And%20An%20Open-label%20Evaluation%20In%20Healthy%20Japanese%20Subjects

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

Other Identifiers

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2015-001821-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

B7841001

Identifier Type: -

Identifier Source: org_study_id

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