NCT07845513尚未招募1 期
A PHASE 1, OPEN-LABEL STUDY TO INVESTIGATE THE PHARMACOKINETICS, SAFETY, AND TOLERABILITY OF PF-08653944 FOLLOWING SINGLE DOSE SUBCUTANEOUS ADMINISTRATION IN OTHERWISE HEALTHY CHINESE ADULT PARTICIPANTS WITH OVERWEIGHT OR OBESITY
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- Pfizer
- 入组人数
- 16
- 主要终点
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of PF-08653944
研究概览
简要总结
The purpose of this study is to learn about:
- How PF-08653944 is changed and removed from the body after taken
- Safety of PF-08653944
- The extent to which side effects can be tolerated after taking PF- 08653944 for the possible treatment of heart failure
This study is seeking participants who:
- Are healthy Chinese adults who are aged 18 years and older
- Have body mass index of 24 - 45 kilograms/meter2
- Have a total body weight of equal to or more than 50 kilograms (110 pounds)
- Do not have prior significant medical conditions, history of drug or alcohol abuse
All participants in this study will receive a single dose of PF-08653944 at the study clinic.
The experiences of the participants receiving the study medicine will be looked at. This will help to see if the study medicine is safe.
Participants will take part in this study for around 16 weeks. During this time, they will have 6 study visits at the study clinic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants 18 years of age or older at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECGs.
- •BMI of 24-45 kg/m2; and a total body weight >50 kg (110 lb).
- •Chinese participants are defined as individuals currently residing in mainland China who were born in China and have both parents of Chinese descent.
排除标准
- •Pregnant or breastfeeding women, or those planning pregnancy during the study.
- •Clinically significant medical conditions including hematologic, renal, endocrine, pulmonary, gastrointestinal (including pancreatitis, gallbladder disease, clinically relevant gastric emptying disorders), cardiovascular, hepatic, psychiatric, neurologic, or severe allergic diseases.
- •Personal or first-degree family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2), or suspected MTC.
- •Active or recent suicidal ideation in the past year, suicidal behavior within the past 5 years, or any psychiatric condition that increases risk in the investigator's judgment.
- •Clinically significant gastric emptying abnormality or chronically taking drugs that directly affect GI motility.
- •Acute gastrointestinal symptoms at screening or Day -
- •Known hypersensitivity to PF-08653944, GLP-1 receptor agonists, or any excipients.
- •Prior participation in any study involving PF-08653944 with at least one dose received.
研究组 & 干预措施
Treatment 1
Experimental
Participants will receive a single subcutaneous (SC) dose of PF-08653944 on Day 1.
干预措施: PF-08653944 (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of PF-08653944
时间窗: Up to 85 days
PK: Maximum Observed Concentration (Cmax) of PF-08653944
时间窗: Up to 85 days
次要结局
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)(Up to 85 days)
研究者
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