NCT06575400招募中1 期
A Phase 1, Randomised, Single-blind, Placebo-controlled Trial to Assess Safety, Tolerability, and Pharmacokinetics of Single and Multiple Rising Subcutaneous Doses of BI 3804379 in Healthy Male and Female Participants and in Stable Patients With Advanced Fibrosis Due to MASH
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Part A, Part B and Part C: Occurrence of any treatment-emergent adverse event (AE) assessed as drug-related by the investigator
研究概览
简要总结
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PKs) of BI 3804379 in healthy male and female participants and in stable patients with advanced liver fibrosis due to MASH following administration of single rising doses and administration of multiple rising doses.
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
- Single (Participant)
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
- •for Part A and Part B:
- •Healthy male or female (of non-child-bearing potential) participants according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR), respiratory rate (RR), temperature (TEMP)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
- •Age of 18 to 65 years (inclusive)
- •Body mass index (BMI) of 18.5 to 30.0 kg/m2 (inclusive)
- •Signed and dated written informed consent in accordance with ICH Harmonized Guideline for Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial Further inclusion criteria apply
- •Inclusion criteria for Part C:
- •1. Male or female patients with advanced liver fibrosis due to MASH, aged between 18 and 70 years (inclusive) Further inclusion criteria apply
排除标准
- •for Part A and Part B:
- •Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator.
- •Repeated measurement of systolic BP outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic BP outside the range of 45 to 90 mmHg, or PR outside the range of 45 to 100 beats per minute (bpm).
- •Any laboratory value outside the reference range that the investigator considers to be of clinical relevance.
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders that the investigator considers to be of clinical relevance.
- •Further exclusion criteria apply
- •Exclusion criteria for Part C:
- •Type 1 diabetes or uncontrolled type 2 diabetes (e.g., hemoglobin A1C (HbA1c) ≥10%, recent major treatment changes, or severe hypoglycemia).
- •Significant weight loss (≥10%) between diagnosis and screening.
- •Relevant surgery after diagnosis or planned during the study period.
- •Evidence of clinically significant or unstable disease increasing risk to the participant.
- •Severe renal impairment (estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m²).
- •Uncontrolled hypertension or significant cardiovascular disease (e.g., recent myocardial infarction, stroke, or heart failure New York Heart Association (NYHA) class III/IV).
- •Clinically relevant ECG abnormalities, including QT interval corrected for heart rate (QTc) prolongation or risk factors for Torsade de Pointes.
- •Participation in another clinical trial or exposure to an investigational drug within 60 days prior to study treatment.
- •Further exclusion criteria apply
研究组 & 干预措施
SRD Part: BI 3804379
Experimental
SRD= Single rising dose
干预措施: BI 3804379 (Drug)
MRD Part: BI 3804379
Experimental
MRD=Multiple rising dose.
干预措施: BI 3804379 (Drug)
结局指标
主要结局
Part A, Part B and Part C: Occurrence of any treatment-emergent adverse event (AE) assessed as drug-related by the investigator
时间窗: Up to Day 84 for Part A and up to Day 235 for Part B and Part C.
SRD part and MRD part: Occurrence of any treatment-emergent adverse event (AE) assessed as drug-related by the investigator
时间窗: Up to Day 84 for SRD part and up to Day 235 for MRD part.
次要结局
- Part A: Cmax (maximum measured concentration of the analyte in serum)(Up to Day 84.)
- Part B and Part C: AUCτ,ss (area under the concentration-time curve of the analyte in serum at steady state over a uniform dosing interval τ)(Up to Day 235.)
- Part B and Part C: Cmax,ss (maximum measured concentration of the analyte in serum at steady state over a uniform dosing interval τ)(Up to Day 235.)
- Part A: AUC0-∞ (area under the concentration-time curve of the analyte in serum over the time interval from 0 extrapolated to infinity)(Up to Day 84.)
- SRD part: AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)(Up to Day 84.)
- SRD part: Cmax (maximum measured concentration of the analyte in plasma)(Up to Day 84.)
- MRD part: AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)(Up to Day 235.)
- MRD part: Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)(Up to Day 235.)
研究者
研究点 (2)
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