NCT07835243尚未招募1 期
A Phase 1, Open-Label, Randomized, Single-Dose Study to Evaluate the Effect of Subcutaneous Injection Site on the Pharmacokinetics of Pegozafermin in Healthy Participants
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
- 入组人数
- 105
- 主要终点
- Area Under the Serum Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUClast) of Pegozafermin
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics (PK) of a single subcutaneous (SC) dose of pegozafermin administered in the abdomen, thigh, or upper arm in healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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
- •Participants with a body mass index (BMI) within the range of 18.5-35.0 kilogram per square meter (kg/m²)
- •Participants in good health, as determined by medical history, physical examination findings, vital signs, electrocardiogram (ECG), and clinical laboratory tests at screening and prior to dosing
- •Participants with willingness and ability to comply with all study requirements
排除标准
- •Participants with a history of pancreatitis or gallbladder/biliary disorders (including cholelithiasis or cholecystitis), clinically significant menstrual abnormalities per investigator judgment, or hypertension
- •Participants with known hypersensitivity to pegozafermin or its excipients or history of severe allergic or hypersensitivity reactions that may place the participant at risk
- •Participants with any abnormality of the skin such as tattoo(s) or scarring or SC tissue at or near potential injection sites that may interfere with administration or assessment of the injection
- •Participants with any history of malignancy
- •Participants who are pregnant, breastfeeding, or planning to become pregnant during the study or within the timeframe in which contraception is required
- •Participants with a positive result for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV)-1 or HIV-2 antibodies or p24 antigen at screening
- •Participants with significant alcohol consumption, defined as > 14 units/week for females or > 21 units/week for males
- •Participants with a history of recent (i.e., 6 months) bone trauma, fracture, or surgery or other clinically significant bone-related conditions
- •Participants with poor peripheral venous access
- •Note: Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Group C
Experimental
Participants will receive pegozafermin as per the schedule specified in the protocol in the upper arm.
干预措施: Pegozafermin (Drug)
Group B
Experimental
Participants will receive pegozafermin as per the schedule specified in the protocol in the thigh.
干预措施: Pegozafermin (Drug)
Group A
Experimental
Participants will receive pegozafermin as per the schedule specified in the protocol in the abdomen.
干预措施: Pegozafermin (Drug)
结局指标
主要结局
Area Under the Serum Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUClast) of Pegozafermin
时间窗: From predose on Day 1 up to Day 22
Area Under the Serum Concentration-Time Curve Extrapolated to Infinity (AUCinf) of Pegozafermin
时间窗: From predose on Day 1 up to Day 22
Maximum Observed Serum Concentration (Cmax) of Pegozafermin
时间窗: From predose on Day 1 up to Day 22
次要结局
- Relative Bioavailability (Frel) of Pegozafermin for Thigh Versus Abdomen(Up to Day 22)
- Frel of Pegozafermin for Upper Arm Versus Abdomen(Up to Day 22)
- Time of Maximum Observed Serum Concentration (Tmax) of Pegozafermin(From predose on Day 1 up to Day 22)
- Terminal Elimination Half-Life (t1/2) of Pegozafermin(From predose on Day 1 up to Day 22)
- Apparent Systemic Clearance (CL/F) of Pegozafermin(From predose on Day 1 up to Day 22)
- Apparent Volume of Distribution (Vz/F) of Pegozafermin(From predose on Day 1 up to Day 22)
- Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)(Up to approximately 50 days)
- Number of Participants With Injection Site Reactions (ISRs)(Up to 24 hours post-dose on Day 1)
研究者
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