Healthy
Conditions
Keywords
Healthy Subjects
Brief 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).
Interventions
DRUGPF-06687234
PF-06687234 will be administered via the SC or the IV route and in either single dose or multiple doses
DRUGPlacebo
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.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | 4 weeks in the single dose portion and 8 weeks in the multiple dose portion | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | — |
| 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. | — |
| 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. | — |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) 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. | 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). |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) 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. | 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). |
| 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. | — |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) 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. | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast |
| Plasma Decay Half-Life (t1/2) 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. | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. |
| Plasma Decay Half-Life (t1/2) 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. | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. |
| Incidence of development of anti-drug antibody (ADA) | up to 2 months | — |
| Incidence of development of neutralizing antibody (NAb) | up to 2 months | — |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) 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. | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) |
Countries
Belgium
Outcome results
None listed