Randomized, Single-blind, Placebo-controlled, Escalating Single-dose Study of Safety, Tolerability, and Pharmacokinetics of Intravenously Administered BAY 1747846 in Healthy Chinese Men
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-emergent adverse events (TEAE)
研究概览
简要总结
The goal of this clinical study was to learn more about BAY1747846 compared to placebo when given as an injection into the vein in Chinese healthy male participants:
- the safety of BAY1747846 when given at increasing single doses
- the level of BAY1747846 in the blood over time when given at increasing single doses.
To answer the first question, the researchers compared the number and severity of medical problems the Chinese participants had after receiving BAY1747846 at increasing doses and placebo respectively. Doctors kept tracking of all medical problems that happened in the study, even if they did not think they might be related to the study treatments.
To answer the second question, the researchers determined:
- the (average) total level of BAY1747846 in the blood, also called AUC
- the (average) highest level of BAY1747846 in the blood, also called Cmax
- how BAY1747846 is removed from the blood, also called clearance (CL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent prior to any study specific tests or procedures
- •Chinese male between 18 and 45 years (inclusive) at screening visit
- •Body mass index (BMI): 18.5 to 30.0 kg/m² (inclusive)
- •Body weight (bw): 50 to 90 kg (inclusive)
- •Participants of reproductive potential must agree to use adequate contraception whenever having sexual intercourse with a woman of child-bearing potential. This applies for the time period from signing of the ICF to at least 1 week after treatment. The definition of adequate contraception will be based on the judgment of the investigator and on local requirements
- •Healthy, based on medical history, physical examination, electrocardiography (ECG), and laboratory tests
排除标准
- •Use of systemic or topically active medication or herbal remedies, prescription or non-prescription, from screening to the first drug administration (only use of contraceptives and occasional use of paracetamol, aspirin or ibuprofen is permissible)
- •Any severe disease within the last 4 weeks prior to the first study drug administration
- •Any clinically relevant finding at the physical examination and chest X ray (posterior-anterior) examination
- •Any clinically relevant deviation from reference ranges of the laboratory parameters at screening or alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin exceeding the upper limit of normal range (ULN) by more than 10%, or creatinine above the ULN, or hemoglobin below 12 g/dL
- •Vital signs: Pulse rate <50 or >90beats/min, Systolic blood pressure <100 or ≥140 mmHg, Diastolic blood pressure <60 or ≥90 mmHg, or other abnormal vital signs
- •Any known disposition for allergic, anaphylactoid, hypersensitivity or idiosyncratic reactions, e.g. any history of clinical signs of hypersensitivity reaction to any agent (including, but not limited to, any allergen, food, drug, chemical, or contrast agent)
- •Family history of hypersensitivity reaction to contrast agent
- •Regular alcohol consumption equivalent to >20 g alcohol per day within 3 months prior to screening
- •Smokers who smoke more than 5 cigarettes per day within 3 months prior to screening and/or who cannot refrain from smoking from screening until the end of hospitalization
- •Criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the participant's safety
研究组 & 干预措施
0.03 mmol Gd/kg BAY1747846 and matching placebo
12 healthy male participants were planned to be enrolled into this arm, 9 on BAY1747846 and 3 on placebo
干预措施: Gadoquatrane (BAY1747846) 0.03 mmol Gd/kg (Drug)
0.03 mmol Gd/kg BAY1747846 and matching placebo
12 healthy male participants were planned to be enrolled into this arm, 9 on BAY1747846 and 3 on placebo
干预措施: Matching placebo (Drug)
0.1 mmol Gd/kg BAY1747846 and matching placebo
12 healthy male participants were planned to be enrolled into this arm, 9 on BAY1747846 and 3 on placebo
干预措施: Gadoquatrane (BAY1747846) 0.1 mmol Gd/kg (Drug)
0.1 mmol Gd/kg BAY1747846 and matching placebo
12 healthy male participants were planned to be enrolled into this arm, 9 on BAY1747846 and 3 on placebo
干预措施: Matching placebo (Drug)
结局指标
主要结局
Number of participants with treatment-emergent adverse events (TEAE)
时间窗: From drug administration up to 7 days after end of test drug administration (from day 1 to day 8)
Including severity of TEAE
次要结局
- Cmax(Pre-dose, on Day 1, Day 2, Day 3 and Day 4)
- AUC(Pre-dose, on Day 1, Day 2, Day 3 and Day 4)
- CL(Pre-dose, on Day 1, Day 2, Day 3 and Day 4)
- CL/bw(Pre-dose, on Day 1, Day 2, Day 3 and Day 4.)