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
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events (AEs)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort 1
Subjects will receive 2mg of PF 06687234 or placebo via the SC route
干预措施: PF-06687234 (Drug)
Cohort 1
Subjects will receive 2mg of PF 06687234 or placebo via the SC route
干预措施: Placebo (Drug)
Cohort 2
Subjects will receive 20mg PF 06687234 or placebo via the SC route
干预措施: PF-06687234 (Drug)
Cohort 2
Subjects will receive 20mg PF 06687234 or placebo via the SC route
干预措施: Placebo (Drug)
Cohort 3
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
干预措施: PF-06687234 (Drug)
Cohort 3
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
干预措施: Placebo (Drug)
Cohort 4
Subjects will receive 40mg of PF 06687234 or placebo via the SC route
干预措施: PF-06687234 (Drug)
Cohort 4
Subjects will receive 40mg of PF 06687234 or placebo via the SC route
干预措施: Placebo (Drug)
Cohort 5
Subjects will receive 80mg of PF 06687234 or placebo via the SC route
干预措施: PF-06687234 (Drug)
Cohort 5
Subjects will receive 80mg of PF 06687234 or placebo via the SC route
干预措施: Placebo (Drug)
Cohort 6
Subjects receive a single dose of PF 06687234 or placebo via the IV route
干预措施: PF-06687234 (Drug)
Cohort 6
Subjects receive a single dose of PF 06687234 or placebo via the IV route
干预措施: Placebo (Drug)
Cohort 7
This is an optional cohort where Japanese subjects will receive PF 06687234 or placebo via the SC route
干预措施: PF-06687234 (Drug)
Cohort 7
This is an optional cohort where Japanese subjects will receive PF 06687234 or placebo via the SC route
干预措施: Placebo (Drug)
Cohort 8
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
干预措施: PF-06687234 (Drug)
Cohort 8
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
干预措施: Placebo (Drug)
Cohort 9
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
干预措施: PF-06687234 (Drug)
Cohort 9
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
干预措施: Placebo (Drug)
Cohort 10
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
干预措施: PF-06687234 (Drug)
Cohort 10
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
干预措施: Placebo (Drug)
Cohort 11
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
干预措施: PF-06687234 (Drug)
Cohort 11
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
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with Adverse Events (AEs)
时间窗: 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.
次要结局
- Incidence of development of anti-drug antibody (ADA)(up to 2 months)
- Incidence of development of neutralizing antibody (NAb)(up to 2 months)
- 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.)
- 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.)
- 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.)
- 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 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.)
- 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 (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.)