jRCT2071210020已完成不适用
Randomized, placebo-controlled, single-blind, dose escalation study to investigate the safety, tolerability, and pharmacokinetics after single and multiple nasal doses of BAY 2586116 in Japanese healthy male participants (Phase 1 study of BAY 2586116 in Japanese healthy male participants)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Other
- 盲法
- Single Blind
入排标准
- 年龄范围
- 20age old over 至 45age old under（—）
- 性别
- Male
入选标准
- •Participants who are overtly healthy as determined by medical evaluation (including medical and surgical history, physical examination, laboratory tests, ECG, vital signs).
- •Participant must be 20 to 45 years of age inclusive, at the time of signing the ICF.
- •BMI above or equal 18.0 and below or equal 29.9 kg/m2 at screening.
- •Japanese.
- •Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •A sexually active man who has not been surgically sterilized has to agree not to act as sperm donor for the time period between signing of the ICF and 90 days after the last administration of study intervention.
排除标准
- •A history of relevant diseases of vital organs, of the CNS (central nervous system) or other organs.
- •Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study intervention will not be normal.
- •Given the nasal administration route, these diseases include (but are not limited to) any symptomatic and/or a history of relevant diseases of the ear, nose, and throat area (e.g. acute allergic rhinitis, acute infectious rhinitis, acute or chronical sinusitis, infection of the upper respiratory tract, symptomatic deviation of the nasal septum or a different relevant impairment of nasal breathing, history of any surgery of the ear, nose, and throat area [exception: sole history of adenectomy and/or tonsillectomy and/or paracentesis >1 year prior to 1st administration of study intervention], anatomical abnormalities of the ear, nose, and throat area [e.g. surgical corrected or uncorrected cheilognathopalatoschisis]).
- •Liver insufficiency or active liver disease, which may include unexplained persistent transaminase elevations.
- •Known or suspected liver disorders (e.g. Morbus Gilbert/Meulengracht) and bile secretion/flow (cholestasis, also history of it).
- •Participants with thyroid disorders as evidenced by assessment of thyroid stimulating hormone levels outside the normal reference range at screening.
- •Personal or familial history of genetically muscular diseases.
- •History of autoimmune disease.
- •Known hypersensitivity to the study interventions (active substances or excipients of the preparations).
- •Known severe allergies, e.g. allergies to more than 3 allergens, allergies affecting the lower respiratory tract, allergic asthma, allergies requiring therapy with corticosteroids, urticarial, or significant non-allergic drug reactions.
- •History of known or suspected malignant tumors.
- •Tendency for vasovagal reactions (e.g. after venipuncture) or history of syncope.
结局指标
主要结局
Number of participants with adverse events
时间窗: From first administration up to 8 days after last dose (follow-up visit)
The researchers will count the number of participants who have medical problems that may or may not be related to the study treatment. These medical problems are also known as adverse events while they are in the study.
次要结局
- Cmax of BAY2586116(Day 1)
- Cmax/D of BAY2586116(Day 1)
- AUC of BAY2586116(Day 1)
- AUC/D of BAY2586116(Day 1)
- Cmax,md of BAY2586116(Day 5)
- Cmax,md/D of BAY2586116(Day 5)
- AUCT,md of BAY2586116(Day 5)
- AUCT,md/D of BAY2586116(Day 5)
研究者
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