A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO CONTROLLED, DOSE ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SINGLE ASCENDING DOSES OF PF-07304814 ADMINISTERED AS A 24-H IV INFUSION IN HEALTHY ADULT PARTICIPANTS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Number of participants with treatment emergent treatment-related adverse event(s)
研究概览
简要总结
The current study is the second clinical administration with PF-07304814, the phosphate prodrug of the active moiety PF-00835231, and the first in healthy adult participants. It is to evaluate safety, tolerability and PK of single escalating doses of PF 07304814 given as a 24-h IV infusion.
详细描述
The current study is the second clinical administration with PF-07304814, the phosphate prodrug of the active moiety PF-00835231, and the first in healthy adult participants. It is to evaluate safety, tolerability and PK of single escalating doses of PF 07304814 given as a 24-h IV infusion. This is a randomized, double-blind, sponsor-open, placebo-controlled trial. There will be 2 cohorts with a total of approximately 16 participants planned (approximately 8 participants in each cohort).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 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 60 years of age. All fertile participants must agree to use a highly effective method of contraception.
- •Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination.
- •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 30.5 kg/m2; and a total body weight >50 kg (110 lb).
- •Capable of giving signed informed consent.
- •Exclusion Criteria
- •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. Hepatitis B vaccination is allowed.
- •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.
- •History of venous thromboembolic event, including deep venous thrombosis or pulmonary embolism.
- •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 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).
- •A positive urine drug test at screening or admission and confirmed by repeat test, if deemed necessary.
- •Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest.
- •Baseline 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
- •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) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
- •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
排除标准
- 未提供
研究组 & 干预措施
Placebo
Placebo assigned
干预措施: Placebo (Drug)
Treatment
PF-07304814 assignment
干预措施: PF-07304814 (Drug)
结局指标
主要结局
Number of participants with treatment emergent treatment-related adverse event(s)
时间窗: Dosing through follow-up call (28-32 days after last dose of investigational product)
Frequency, severity and causal relationship of treatment emergent adverse events (TEAEs) and withdrawals due to TEAEs
Number of participants with laboratory test findings of potential clinical importance
时间窗: Dosing through Day 5 of last period
Percentage of subjects with laboratory abnormalities
Number of participants with vital signs findings of potential clinical importance
时间窗: Dosing through Day 5 of last period
blood pressure, pulse rate, temperature, respiration rate
Number of participants with ECG findings of potential clinical importance
时间窗: Dosing through Day 5 of last period
Number of subjects with change from baseline in electrocardiogram (ECG) parameters
次要结局
- Plasma CL of PF-07304814 (prodrug)(0-48 hours post the start of dosing)
- Plasma Cmax of PF-07304814 (prodrug) and PF 00835231 (active moiety)(0-48 hours post the start of dosing)
- Plasma AUClast of PF-07304814 (prodrug) and PF 00835231 (active moiety)(0-48 hours post the start of dosing)
- Plasma AUCinf of PF-07304814 (prodrug) and PF 00835231 (active moiety)(0-48 hours post the start of dosing)
- PF-00835231 urinary PK: Ae(0-36 hours post the start of dosing)
- Plasma AUCinf (dn) of PF-07304814 (prodrug) and PF 00835231 (active moiety)(0-48 hours post the start of dosing)
- Plasma Css of PF-07304814 (prodrug) and PF 00835231 (active moiety)(0-48 hours post the start of dosing)
- Plasma Css (dn) of PF-07304814 (prodrug) and PF 00835231 (active moiety)(0-48 hours post the start of dosing)
- Plasma C24 of PF-07304814 (prodrug) and PF 00835231 (active moiety)(0-48 hours post the start of dosing)
- Plasma Vdss of PF-07304814 (prodrug)(0-48 hours post the start of dosing)
- PF-00835231 urinary PK: Ae%(0-36 hours post the start of dosing)
- Plasma t1/2 of PF-07304814 (prodrug) and PF 00835231 (active moiety)(0-48 hours post the start of dosing)