NCT04459767已完成1 期
A PHASE 1, RANDOMIZED, DOUBLE-BLIND, THIRD-PARTY OPEN, PLACEBO-CONTROLLED, SINGLE ASCENDING DOSE STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF PF-07285557 (VUPANORSEN) ADMINISTERED SUBCUTANEOUSLY IN JAPANESE HEALTHY ADULTS WITH ELEVATED TRIGLYCERIDES
适应症
干预措施
相关药物
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
- Incidence of treatment related adverse events
研究概览
简要总结
This is a Phase 1, randomized, double blind, third party open (i.e., participant blind, investigator blind and sponsor open), placebo controlled, single ascending dose study to investigate the safety, tolerability, pharmacokinetic and pharmacodynamics of vupanorsen in Japanese healthy adult participants with elevated triglycerides.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female participants must be 20 to 65 years of age, inclusive, at the time of signing the ICD.
- •Participants must have four Japanese grandparents born in Japan.
- •Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests (except for TG levels), and 12 lead ECG monitoring.
- •Fasting TG >= 90 mg/dL at Screening
- •Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- •BMI of 17.5 to 35.0 kg/m2; and a total body weight >50 kg (110 lb)
- •Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
- •History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, or HCVAb.
- •Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- •History of allergic or anaphylactic reaction.
- •Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study intervention.
- •Previous administration with an investigational drug within 4 months or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer).
- •A positive urine drug test.
- •Screening supine BP >=140 mm Hg (systolic) or >=90 mm Hg (diastolic), following at least 5 minutes of supine rest. If BP is >=140 mm Hg (systolic) or >=90 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility.
- •Baseline 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.
- •Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary:
- •AST or ALT level >=1.25 × ULN;
- •Total bilirubin level >=1.5 × ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is=<ULN.
- •History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
- •Blood donation (excluding plasma donations and platelet donations) of approximately 400 mL within 3 months or >=200 mL within a month prior to dosing. Additionally, approximately >=400 mL within 4 months for female participants.
- •History of sensitivity to heparin or heparin induced thrombocytopenia.
- •History of substance abuse within 12 months of the screening visit.
- •Pregnant females; breastfeeding females.
- •Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol.
- •Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
研究组 & 干预措施
Vupanorsen 80 milligram (mg)
Experimental
Participants will receive one, 0.8 milliliter (mL) subcutaneous injection with vupanorsen 100 mg/mL solution
干预措施: Vupanorsen (Drug)
Vupanorsen 160 mg
Experimental
Participants will receive two, 0.8 mL subcutaneous injections with vupanorsen 100 mg/mL solution
干预措施: Vupanorsen (Drug)
Placebo
Placebo Comparator
Participants in Cohort 1 (vupanorsen 80 mg) will receive one 0.8 mL subcutaneous injection with 0.9% sodium chloride in water.
Participants in Cohort 2 (vupanorsen 160 mg) will receive two 0.8 mL subcutaneous injections with 0.9% sodium chloride in water.
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of treatment related adverse events
时间窗: Day 0-90
Incidence and magnitude of abnormal laboratory findings
时间窗: Day 0-90
Incidence of abnormal and clinically relevant changes in pulse rate
时间窗: Day 0-90
Incidence of abnormal and clinically relevant changes in electrocardiogram
时间窗: Day 0-90
Incidence of abnormal and clinically relevant changes in supine blood pressure
时间窗: Day 0-90
次要结局
- Area under the plasma concentration-time profile from time zero to infinity (AUCinf)(Day 0-90)
- Percentage changes from baseline in non-high-density lipoprotein cholesterol(Day 0-90)
- Percentage changes from baseline in apolipoprotein B total(Day 0-90)
- Apparent volume of distribution (Vz/F)(Day 0-90)
- Percentage changes from baseline in total cholesterol(Day 0-90)
- Percentage changes from baseline in triglyceride(Day 0-90)
- Area under the plasma concentration-time profile from time zero to 24 hours post-dose (AUC24h)(Day 0-90)
- Apparent clearance (CL/F)(Day 0-90)
- Percentage changes from baseline in serum angiopoietin-like protein 3(Day 0-90)
- Percentage changes from baseline in apolipoprotein A-1(Day 0-90)
- Maximum observed plasma concentration (Cmax)(Day 0-90)
- Area under the plasma concentration-time profile from time zero to the last measurable concentration (AUClast)(Day 0-90)
- Percentage changes from baseline in low density lipoprotein cholesterol(Day 0-90)
- Percentage changes from baseline in very low density lipoprotein cholesterol(Day 0-90)
- Percentage changes from baseline in apolipoprotein C-III(Day 0-90)
- Time to reach maximum observed plasma concentration (Tmax)(Day 0-90)
- Area under the plasma concentration-time profile from time zero to 48 hours post-dose (AUC48h)(Day 0-90)
- Terminal elimination half life (t1/2)(Day 0-90)
研究者
研究点 (1)
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