Study in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06687234

Pfizer

Status and phase: Terminated; Phase 1

Conditions: Healthy

Treatments: Drug: PF-06687234; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02711462

DEKAVIL (Other Identifier)

B7581001

2015-000710-22 (EudraCT Number)

Details and patient eligibility

About

This Phase 1 study will be a double blind, third party open (ie, subject blind, investigator blind and Sponsor open), randomized, placebo controlled, single and multiple dose escalation study in healthy subjects, females of non childbearing potential and males between the ages of 18 and 55 years, inclusive. There may be up to 11 Cohorts in the study. Approximately 7 cohorts are anticipated in the Single Dose (SD) portion of the study and up to 4 cohorts are anticipated in the Multiple Dose (MD) portion of the study.

Following the last subject Day 28 visit from the first two single dose cohorts (Cohorts 1 and 2), all available data inclusive of Day 28 will be evaluated for PK, immunogenicity, safety and tolerability. FDA review and agreement to move forward will take place before the remaining single dose cohorts and the multiple dose phase (Cohorts 3 to 11) can be initiated.

A total of up to approximately 82 subjects are anticipated to be enrolled in the study. The duration of dosing in the multiple dose cohorts would be 4 weeks and the regimen may include weekly (total of 5 doses), every 2 weeks (total of 3 doses) or monthly dosing (total of two doses).

Enrollment: 10 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

INCLUSION CRITERIA

• Healthy females of non childbearing potential and healthy males
• No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
• Ability to personally sign and date the informed consent document and able to comply with schedule of activities
• For Single Dose Cohort 7 only, Japanese subjects must have four biological Japanese grandparents born in Japan.

EXCLUSION CRITERIA

• Evidence or history of clinically significant health concerns
• Treatment with an investigational drug within 30 days
• Exposure to any live vaccines within 28 days prior to investigational product administration.
• History of drug and/ or alcohol abuse and tobacco use equivalent of 5 cigarettes per day.
• Known history of infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus
• Pregnant female subjects
• History of sensitivity to heparin
• Unwilling or unable to comply with the Lifestyle Guidelines as stated in the protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

10 participants in 11 patient groups

Cohort 1

Other group

Description:

Subjects will receive 2mg of PF 06687234 or placebo via the SC route

Treatment:

Drug: Placebo

Drug: PF-06687234

Cohort 2

Other group

Description:

Subjects will receive 20mg PF 06687234 or placebo via the SC route

Treatment:

Drug: Placebo

Drug: PF-06687234

Cohort 3

Other group

Description:

This is an optional cohort that may be added anytime during the study. In this cohort, subjects will receive PF 06687234 or placebo via the SC route

Treatment:

Drug: Placebo

Drug: PF-06687234

Cohort 4

Other group

Description:

Subjects will receive 40mg of PF 06687234 or placebo via the SC route

Treatment:

Drug: Placebo

Drug: PF-06687234

Cohort 5

Other group

Description:

Subjects will receive 80mg of PF 06687234 or placebo via the SC route

Treatment:

Drug: Placebo

Drug: PF-06687234

Cohort 6

Other group

Description:

Subjects receive a single dose of PF 06687234 or placebo via the IV route

Treatment:

Drug: Placebo

Drug: PF-06687234

Cohort 7

Other group

Description:

This is an optional cohort where Japanese subjects will receive PF 06687234 or placebo via the SC route

Treatment:

Drug: Placebo

Drug: PF-06687234

Cohort 8

Other group

Description:

Subjects in this cohort may receive 20 mg of PF 06687234 or placebo via the SC route every week with a total of 5 doses

Treatment:

Drug: Placebo

Drug: PF-06687234

Cohort 9

Other group

Description:

Subjects in this cohort may receive 40 mg of PF 06687234 or placebo via the SC route every two weeks with a total of 3 doses

Treatment:

Drug: Placebo

Drug: PF-06687234

Cohort 10

Other group

Description:

This is an optional cohort. The maximum dose tested in the multiple dose cohort will not exceed the highest dose tested in the single dose cohorts

Treatment:

Drug: Placebo

Drug: PF-06687234

Cohort 11

Other group

Description:

This is an optional cohort. The maximum dose tested in the multiple dose cohort will not exceed the highest dose tested in the single dose cohorts

Treatment:

Drug: Placebo

Drug: PF-06687234