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

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-30

Study Completion Date

2019-09-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

First In Human, Single Escalating Oral Dose Study Of PF-06882961 In Healthy Adult Subjects

NCT03309241

Healthy Subjects

COMPLETED PHASE1

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

NCT03974776

Healthy

COMPLETED PHASE1

A First-in-human Study of Single Doses of PF-07328948 Which is Given to Healthy Adult Participants

NCT05654181

Healthy

COMPLETED PHASE1

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PF-06842874 in Healthy Participants

NCT04124653

Healthy Participants

COMPLETED PHASE1

Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Intravenous and Multiple Subcutaneous and Intravenous Doses of PF-06480605 in Healthy Subjects.

NCT01989143

Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort 1

Single subcutaneous administration of PF-06946860 at planned dose level 0.1 mg, or placebo

Group Type EXPERIMENTAL

PF-06946860

Intervention Type BIOLOGICAL

PF-06946860 administered subcutaneously

Placebo

Intervention Type OTHER

Placebo, administered subcutaneously

Cohort 2

Single subcutaneous administration of PF-06946860 at planned dose level 0.3 mg, or placebo

Group Type EXPERIMENTAL

PF-06946860

Intervention Type BIOLOGICAL

PF-06946860 administered subcutaneously

Placebo

Intervention Type OTHER

Placebo, administered subcutaneously

Cohort 3

Single subcutaneous administration of PF-06946860 at planned dose level 1 mg, or placebo

Group Type EXPERIMENTAL

PF-06946860

Intervention Type BIOLOGICAL

PF-06946860 administered subcutaneously

Placebo

Intervention Type OTHER

Placebo, administered subcutaneously

Cohort 4

Single subcutaneous administration of PF-06946860 at planned dose level 3 mg, or placebo

Group Type EXPERIMENTAL

PF-06946860

Intervention Type BIOLOGICAL

PF-06946860 administered subcutaneously

Placebo

Intervention Type OTHER

Placebo, administered subcutaneously

Cohort 5

Single subcutaneous administration of PF-06946860 at planned dose level 10 mg, or placebo

Group Type EXPERIMENTAL

PF-06946860

Intervention Type BIOLOGICAL

PF-06946860 administered subcutaneously

Placebo

Intervention Type OTHER

Placebo, administered subcutaneously

Cohort 6

Single subcutaneous administration of PF-06946860 at planned dose level 30 mg, or placebo

Group Type EXPERIMENTAL

PF-06946860

Intervention Type BIOLOGICAL

PF-06946860 administered subcutaneously

Placebo

Intervention Type OTHER

Placebo, administered subcutaneously

Cohort 7

Single subcutaneous administration of PF-06946860 at planned dose level 100 mg, or placebo

Group Type EXPERIMENTAL

PF-06946860

Intervention Type BIOLOGICAL

PF-06946860 administered subcutaneously

Placebo

Intervention Type OTHER

Placebo, administered subcutaneously

Optional: Cohort 8

Optional: single subcutaneous administration of PF-06946860 at planned dose level 30 mg, or placebo in healthy Japanese subjects

Group Type EXPERIMENTAL

PF-06946860

Intervention Type BIOLOGICAL

PF-06946860 administered subcutaneously

Placebo

Intervention Type OTHER

Placebo, administered subcutaneously

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PF-06946860

PF-06946860 administered subcutaneously

Intervention Type BIOLOGICAL

Placebo

Placebo, administered subcutaneously

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes