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

Healthy Clinical Trial

Official title:

A Phase 1, Double Blind, Third-Party Open, Randomized, Placebo Controlled, Single And Multiple Dose, Parallel Group Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF-06687234 In Healthy Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02711462
• Other study ID #: B7581001
• Secondary ID: 2015-000710-22DE
• Status: Terminated
• Phase: Phase 1
• First received: January 8, 2016
• Last updated: November 4, 2016
• Start date: February 2016
• Est. completion date: August 2016

Study information

• Verified date: November 2016
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PF-06687234
PF-06687234 will be administered via the SC or the IV route and in either single dose or multiple doses
• Placebo
In Cohorts 1 and 2, up to 1 subject will receive placebo. In all other Cohorts (Cohorts 3 to 11), up to 2 subjects will receive placebo.

Locations

Country	Name	City	State
Belgium	Pfizer Clinical Research Unit	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events (AEs)	To determine the safety and tolerability of PF 06687234 by assessing averse events, vital signs measurements, 12 lead ECGs, physical examination findings, blood and urine safety tests including ferritin, transferrin, serum iron, reticulocytes, hemoglobin, platelets and any abnormal laboratory results.	4 weeks in the single dose portion and 8 weeks in the multiple dose portion	Yes
Secondary	Maximum Observed Plasma Concentration (Cmax) of PF 06687234 (IV and SC single doses)		Day 1 prior to 0 hr & 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post dose and 8 and 11 days post dose along with early termination or follow up visit.	No
Secondary	Maximum Observed Plasma Concentration (Cmax) of PF 06687234 (SC multiple doses)		Day 1 and Day 29 prior to 0 hr & 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post dose. Pre-dose samples on Day 8, 15, 22, 36, 39 and 43 along with early termination or follow up visit.	No
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF 06687234 (IV and SC single doses)		Day 1 prior to 0 hr & 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post dose and 8 and 11 days post dose along with early termination or follow up visit.	No
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF 06687234 (SC multiple doses)		Day 1 and Day 29 prior to 0 hr & 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post dose. Pre-dose samples on Day 8, 15, 22, 36, 39 and 43 along with early termination or follow up visit.	No
Secondary	Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF 06687234 (IV and SC single doses)	AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).	Day 1 prior to 0 hr & 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post dose and 8 and 11 days post dose along with early termination or follow up visit.	No
Secondary	Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF 06687234 (SC multiple doses)	AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).	Day 1 and Day 29 prior to 0 hr & 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post dose. Pre-dose samples on Day 8, 15, 22, 36, 39 and 43 along with early termination or follow up visit.	No
Secondary	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF 06687234 (IV and SC single doses)	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)	Day 1 prior to 0 hr & 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post dose and 8 and 11 days post dose along with early termination or follow up visit.	No
Secondary	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF 06687234 (SC multiple doses)	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast	Day 1 and Day 29 prior to 0 hr & 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post dose. Pre-dose samples on Day 8, 15, 22, 36, 39 and 43 along with early termination or follow up visit.	No
Secondary	Plasma Decay Half-Life (t1/2) of PF 06687234 (IV and SC single doses)	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	Day 1 prior to 0 hr & 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post dose and 8 and 11 days post dose along with early termination or follow up visit.	No
Secondary	Plasma Decay Half-Life (t1/2) of PF 06687234 (SC multiple doses)	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	Day 1 and Day 29 prior to 0 hr & 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post dose. Pre-dose samples on Day 8, 15, 22, 36, 39 and 43 along with early termination or follow up visit.	No
Secondary	Incidence of development of anti-drug antibody (ADA)		up to 2 months	Yes
Secondary	Incidence of development of neutralizing antibody (NAb)		up to 2 months	Yes

External Links

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