A Double-Blind, Placebo-Controlled, Randomized, Multipart, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered JNJ-75220795
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Number of Participants With Treatment-Emergent Signs and Symptoms/ Adverse Events (AEs)
研究概览
简要总结
The purpose of the study is to assess the safety and tolerability of single and multiple subcutaneous (SC) doses of JNJ-75220795.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, 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
- 否
入选标准
- •Participants with certain genetic predisposition to non-alcoholic fatty liver disease (NAFLD) determined at screening
- •Presence of liver steatosis at screening
- •Participants on anti-hypertensive and/or lipid lowering medications and/or glucose lowering medications must be on stable dose(s) for at least 4 weeks prior to screening
- •Weight stable defined as no more than 5% body weight loss or gain within 3 months prior to screening and no more than 5% body weight loss or gain from screening to randomization
排除标准
- •Known allergies, hypersensitivity, or intolerance to JNJ-75220795 or its excipients
- •History of hepatitis B surface antigen (HbsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HbsAg or anti-HCV at screening
- •History of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at screening
研究组 & 干预措施
Single Ascending Dose (SAD)
Participants in cohorts 1-5 and cohorts 3a-5a will receive subcutaneous (SC) injection of single dose (Part A) of JNJ-75220795 or matching placebo.
干预措施: JNJ-75220795 (Drug)
Single Ascending Dose (SAD)
Participants in cohorts 1-5 and cohorts 3a-5a will receive subcutaneous (SC) injection of single dose (Part A) of JNJ-75220795 or matching placebo.
干预措施: Placebo (Drug)
Multiple Ascending Dose (MAD)
Participants in cohorts 6-8 will receive SC injection of 2 doses (Part B) of JNJ-75220795 or matching placebo. Participants in cohorts 9-11 will receive SC injection of 4 doses (Part C) of JNJ-75220795 or matching placebo.
干预措施: JNJ-75220795 (Drug)
Multiple Ascending Dose (MAD)
Participants in cohorts 6-8 will receive SC injection of 2 doses (Part B) of JNJ-75220795 or matching placebo. Participants in cohorts 9-11 will receive SC injection of 4 doses (Part C) of JNJ-75220795 or matching placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Treatment-Emergent Signs and Symptoms/ Adverse Events (AEs)
时间窗: Up to Day 182
Number of participants with treatment-emergent signs and symptoms/adverse events (including allergic reactions/hypersensitivity and local injection site reactions) will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Treatment-emergent adverse events (TEAEs) are defined as AEs with onset or worsening on or after date of first dose of study treatment.
Number of Participants With Change From Baseline in Clinical Laboratory Abnormalities
时间窗: Baseline, up to Day 168
Number of participants with change from baseline in clinical laboratory abnormalities including hematology, chemistry and urinalysis will be reported.
Number of Participants With Change From Baseline in Vital Signs Abnormalities
时间窗: Baseline, up to Day 168
Number of participants with change from baseline in vital signs abnormalities including temperature, heart rate, respiratory rate, and blood pressure (supine) will be reported.
Number of Participants With Change From Baseline in Physical Examination Abnormalities
时间窗: Baseline, up to Day 168
Number of participants with change from baseline in physical examination abnormalities will be reported.
Number of Participants With Change From Baseline in Electrocardiogram (ECG) Abnormalities
时间窗: Baseline, up to Day 168
Number of participants with change from baseline in ECG abnormalities will be reported.
次要结局
- Percent Change From Baseline in Liver Fat Content(Baseline, weeks 6, 12, 18 and 24)
- Plasma Concentration of JNJ-75220795 Over Time(SAD: Predose, up to Day 3 and MAD: Predose, up to Day 86)
- Percentage of Participants With Treatment-emergent Anti Drug Antibodies (ADA)(Up to Day 168)