A PHASE 1, RANDOMIZED, DOUBLE-BLIND, THIRD-PARTY OPEN, PLACEBO-CONTROLLED STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY FOLLOWING SINGLE SUBCUTANEOUS DOSE OF PF-06480605 IN CHINESE HEALTHY PARTICIPANTS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Area Under the Curve From Time 0 to End of Dosing Interval (AUC14day) of PF-06480605
研究概览
简要总结
This is a Phase 1, single-center, randomized, double-blind, third-party open (ie, participant blind, investigator blind and sponsor open), placebo controlled study to investigate PK, safety, tolerability, immunogenicity, and PD of PF 06480605 following a single subcutaneous dose of PF-06480605 450 mg and 150 mg (if needed) in Chinese healthy adult participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female participants must be 18 to 45 years of age, inclusive, at the time of signing the ICD.
- •Male and female Chinese participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital sign and 12-lead ECG
- •BMI of 19 to 27 kg/m2; and a total body weight >50 kg.
排除标准
- •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 HIV infection, hepatitis B, hepatitis C or syphilis; positive testing for HIV, hepatitis B, HCVAb or serological reaction of syphilis.
- •History of allergic or anaphylactic reaction to a therapeutic drug.
- •History of recent active infections within 28 days prior to the screening visit.
- •Participants with a fever within 48 hours prior to dosing.
- •History of TB or active or latent or inadequately treated infection.
- •Recent exposure to live vaccines within 28 days of the screening visit.
- •A positive pregnancy test.
研究组 & 干预措施
Cohort 1
12 participants will be randomly assigned at an allocation ratio of 3:1 to the active treatment 450mg and placebo arms.
干预措施: 450mg (Drug)
Cohort 1
12 participants will be randomly assigned at an allocation ratio of 3:1 to the active treatment 450mg and placebo arms.
干预措施: Placebo (Drug)
Cohort 2
12 participants will be randomly assigned at an allocation ratio of 3:1 to the active treatment 150mg and placebo arms.
干预措施: 150mg (Drug)
Cohort 2
12 participants will be randomly assigned at an allocation ratio of 3:1 to the active treatment 150mg and placebo arms.
干预措施: Placebo (Drug)
结局指标
主要结局
Area Under the Curve From Time 0 to End of Dosing Interval (AUC14day) of PF-06480605
时间窗: At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, and 336 hours post dose on Day 1
AUC14day is area under the curve from time 0 to end of dosing interval (Day 14, 336 hours).
Maximum Observed Concentration (Cmax) of PF-06480605
时间窗: At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1
Cmax is the maximum observed plasma concentration.
Time for Cmax (Tmax) of PF-06480605
时间窗: At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1
Tmax is the time for Cmax.
Area Under the Plasma Concentration Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06480605
时间窗: At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1
AUCinf is area under the plasma concentration time profile from time 0 extrapolated to infinite time.
Terminal Half-life (t1/2) of PF-06480605
时间窗: At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1
t1/2 is the terminal half-life (time required for the plasma concentration to decline by 50%)
次要结局
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)(Day 1 to Day 114)
- Number of Participants With Change From Baseline in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria(From Baseline (BL) to Day 114)
- Number of Participants With Change From Baseline in Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria(From BL to Day 114)
- Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality)(From BL to Day 114)
- Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06480605(At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1)
- Apparent Volume of Distribution (Vz/F) of PF-06480605(At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1)
- Apparent Oral Clearance (CL/F) of PF-06480605(At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1)
- Number of Participants With Positivie Anti-drug Antibody (ADA) Against PF-06480605(On Days 1 (prior to dose), 15, 29, 57, 85 and 114)
- Number of Participants With Neutralizing Antibody (NAb) Against PF-06480605(On Days 1 (prior to dose), 15, 29, 57, 85 and 114)
- Total Soluble Tumor Necrosis Factor Like Ligand 1A (sTL1A) Protein Concentration in Serum(On Days 1 (prior to dose), 2, 5, 15, 29, 57, 85 and 114)