JPRN-jRCT2031210658已完成1 期
Phase I Clinical Study in Japanese Healthy Adult Males to Evaluate the Safety, Tolerability, and Pharmacokinetics of TR-012001
Kanazashi Shuichi0 个研究点目标入组 21 人开始时间: 2022年3月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
研究概览
简要总结
In this study, four doses of TR-012001 were administered to healthy Japanese adult males, and the safety and tolerability of TR-012001 under the condition of this study were demonstrated.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 45age old（—）
- 性别
- Male
入选标准
- •(1)Those who have been fully informed of the purpose and content of this study prior to the start of screening, and have freely and voluntarily given written consent to participate in this study.
- •(2)Those who are at least 20 years old and under 45 years old on the date of obtaining document consent.
- •(3)Body weight of 50 kg or more at screening and Body Mass Index (BMI) of 18.5 kg/m2 to 25.0 kg/m2.
- •(4)Patients who have been diagnosed as healthy by the investigator through a screening test and have been determined to be eligible for this study.
- •(5)Those who agree to use the contraceptive methods described in the contraceptive method guidance throughout the study period.
排除标准
- •(1)Persons with angle-closure glaucoma.
- •(2)Persons with asthma.
- •(3)Patients with otolaryngological diseases or nasal findings (rhinitis, nasal discharge, nasal obstruction, epistaxis, nasal septal curvature, etc.) that may affect this study (as examined by an otolaryngologist). In particular, with regard to nasal septal curvature, if it is considered to affect this study, such as inability to insert a nasal device. At the time of screening, an olfactory test is conducted using Open Essence test kit, and as a rule, those with less than 8 correct answers out of 12 items are excluded.
- •(4)Persons with mental, central nervous system, cardiopulmonary, hepatic, renal, hematological, metabolic, or other diseases that may affect this study.
- •(5)A lifetime history of suicide attempts (including ongoing, previously interrupted or aborted attempts) or suicidal ideation within 6 months prior to screening. Assess using the C-SSRS. If there is a history of suicidal ideation, the timing of the ideation should be confirmed.
- •(6)Those with abnormal resting blood pressure and pulse rate (any of the following) at screening.
- •- Supine systolic blood pressure 140 mmHg or above or less than 90 mmHg
- •- Supine diastolic blood pressure 90 mmHg or above or less than 50 mmHg
- •- Supine pulse rate of less than 40 beats per minute or more than 100 beats per minute
- •- Systolic blood pressure in the standing position (after 3 minutes in the standing position) is 20 mmHg or more lower than in the supine position, or symptoms such as dizziness are present.
- •(7)Those with a fever (37.5 degree Celsius or higher).
- •(8)Patients with hemoglobin level less than 13.0 g/dL at screening.
- •(9)Others who have abnormal findings in blood or urine tests and who are judged by the investigator to be unsuitable as subjects for this study.
- •(10)Those who have abnormalities in the electrocardiogram at the time of screening and who are judged by the investigator to be unsuitable as subjects for this study.
- •(11)Persons who are hypersensitive or allergic to drugs used in this clinical trial, or any additive of TR-012001, or who have a history of severe allergy (e.g. anaphylaxis) to other drugs or other substances.
- •(12)Persons with chronic abnormal bowel movements (chronic constipation, chronic diarrhea, irritable bowel syndrome, etc.).
- •(13)Previous resection of the upper gastrointestinal tract (esophagus, stomach, duodenum, upper small intestine) (excluding appendicectomy).
- •(14)Persons who have taken drugs (prescription drugs, over-the-counter drugs, herbal medicines, dietary supplements, vitamins, etc.) within one week prior to admission (or for a longer period of time equal to five times the half-life), or who will be required to take such drugs by the end of the examination.
- •(15)Persons who have used nasal medications within 1 week (or 5 times the half-life, whichever is longer) prior to admission, or who need to use nasal medications by the end of the study.
- •(16)Smokers, or those who have quit smoking within 6 months prior to admission.
- •(17)Alcoholics, drug addicts, and those who are positive in urine drug abuse screening tests (as a rule, phencyclidine, benzodiazepines, cocaine, methamphetamine, marijuana, morphine narcotics, barbiturates, tricyclic antidepressants, methylenedioxymethamphetamine, oxycodone, propoxyphene) in the following tests.
- •(18)Those who have collected 400 mL or more of blood within 12 weeks prior to admission or 200 mL or more of blood within 4 weeks through blood don
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