A Phase 1, Randomized, Double-Blind, Third-Party Open, Placebo-Controlled, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, Tolerability, Immunogenicity, and Pharmacodynamics Following Intravenous Dose of PF-07275315 in Chinese Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma Concentration (Cmax)
研究概览
简要总结
The purpose of this study is to learn if the study medicine (called PF-07275315) is safe and how it is processed in healthy Chinese participants. This study is seeking participants who:
- Are between 18 to 65 years of age.
- Are Chinese participants who are overtly healthy as determined by medical evaluation.
- Have a BMI (body mass index) of 19 to 28 kilogram per meter squared; and a total body weight of more than50 kilograms (110 pounds).
All participants in this study will receive study medicine. About three-fourths will receive PF-07275315 and one-fourth will receive placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. The study medicine will be given as an IV infusion (directly into a vein) at the study clinic only one time.
The study will compare the experiences of people receiving PF-07275315 to those of people who do not. This will help see if PF-07275315 is safe and how it behaves inside the human body.
Participants will take part in this study for up to 181 days. During this time, the participants will stay at the study clinic for 5 days. After the stay, the participants will have 8 study visits at the study clinic.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female participants aged 18 to 65 years.
- •Body mass index (BMI) of 19-27.9 kilogram per meter squared, inclusive, and a total body weight >50 kilograms (110 pounds).
- •Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •Capable of giving signed informed consent.
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
- •History of human immunodeficiency virus (HIV) infection, hepatitis B, hepatitis C, or syphilis; positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb), or syphilis.
- •Evidence of active, latent, untreated or inadequately treated infection with Mycobacterium tuberculosis (TB).
- •Participants with any acute or chronic infections or infection history as per protocol required.
- •History of fever within 7 days prior to dosing.
- •Recent exposure to live or attenuated vaccines within 28 days of the screening visit.
- •Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- •Use of prohibited concomitant medication within 7 days or 5 half-lives (whichever is longer) prior to the administration of PF-
- •Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives preceding the administration of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.
- •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.
- •Standard 12 lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.
- •Participants with any protocol defined abnormalities in clinical laboratory tests at screening.
研究组 & 干预措施
PF-07275315
Participants will receive a single dose of PF-07275315 via IV infusion
干预措施: PF-07275315 (Drug)
Placebo
Participants will receive a single dose of placebo via IV infusion
干预措施: Placebo (Other)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax)
时间窗: Up to Day 181
Area under the concentration-time curve from 0 to time of last measurable concentration (AUClast)
时间窗: Up to Day 181
Time to Reach Maximum Observed Plasma Concentration (Tmax)
时间窗: Up to Day 181
area under the concentration-time curve from time 0 to 336 hours (AUC336)
时间窗: Up to Day 181
Incidence of treatment-emergent adverse events (TEAEs)
时间窗: Up to Day 181
Area under the concentration-time curve from time 0 to infinity (AUCinf)
时间窗: Up to Day 181
Incidence of treatment-emergent serious adverse events (SAEs)
时间窗: Up to Day 181
Incidence of abnormal and clinically relevant changes in electrocardiogram
时间窗: Up to Day 181
Incidence of abnormal and clinically relevant changes in laboratory assessments
时间窗: Up to Day 181
Terminal phase half-life (t½)
时间窗: Up to Day 181
Incidence of abnormal and clinically relevant changes in vital signs
时间窗: Up to Day 181
次要结局
- Clearance (CL) of PF-07275315(Up to Day 181)
- volume of distribution (Vss)(Up to Day 181)
- mean residence time (MRT)(Up to Day 181)
- Incidence of the neutralizing antibodies (NAb) against PF-07275315, if appropriate and feasible(Up to Day 181)
- Change from baseline in serum levels of total immunoglobulin E (IgE)(Up to Day 181)
- Incidence of the Development of Anti-Drug Antibodies (ADA) against PF-07275315(Up to Day 181)
- Change from baseline in serum levels of chemokine (C-C motif) ligand 17 (CCL17) / thymus and activation regulated chemokine (TARC)(Up to Day 181)