A PHASE 1, RANDOMIZED, DOUBLE BLIND, SPONSOR-OPEN, PLACEBOCONTROLLED, SINGLE DOSE ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SUBCUTANEOUS ADMINISTRATION OF PF-07999415 IN HEALTHY ADULT PARTICIPANTS
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Pfizer
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Number of participants with treatment emergent adverse events.
研究概览
简要总结
The purpose of this clinical study is to learn about the safety and effects of the study medicine (called PF-07999415) in healthy adult participants.
This study is seeking volunteers aged 18 to 65 years old who do not have any major health issues.
Some participants in this study will receive a single dose of PF-07999415 as a shot in the thigh, abdomen, or arm at the study clinic. Afterward, participants will stay in a hospital-like setting for 2 weeks, where they will be monitored for reactions to the study medicine.
The study team will compare the experiences of people receiving PF-07999415 to those of the people who do not. This will help the study team decide if PF-07999415 is safe.
Participants will take part in this study for 3 to 7 months. During this time, participants will stay at the healthcare facility for 2 weeks and then come back for study visits every 2-4 weeks until completing the study.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Male and female participants of non-childbearing potential aged 18 to 65 years, inclusive, at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- •Body Mass Index (BMI) of 18-33 kg/m2 and a total body weight >50 kg (110 lb).
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, dermatological, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- •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.
- •Previous administration of an investigational product (drug or vaccine) 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). Participation in studies of other investigational products (drug or vaccine) at any time during participation in this study.
研究组 & 干预措施
PF-07999415
干预措施: PF-07999415 (Biological)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with treatment emergent adverse events.
时间窗: First dose (Day 1) to up to final follow-up visit (Day 120)
次要结局
- Area under the concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast) for PF-07999415(First dose (Day 1) to up to final follow-up visit (Day 120))
- Maximum observed concentration (Cmax) for PF-07999415(First dose (Day 1) to up to final follow-up visit (Day 120))
- Time to maximum observed concentration (Tmax) for PF-07999415(First dose (Day 1) to up to final follow-up visit (Day 120))