ISRCTN41969875已完成1 期
A single-center, open-label, Phase I study to investigate the pharmacokinetics, safety, and tolerability of gantenerumab in healthy Chinese participants following single subcutaneous administration of a high-concentration liquid formulation in the abdomen
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Healthy Chinese male and female subjects who are 18 to 60 years of age, inclusive, at the time of signing informed consent form (ICF)
- •2. Healthy status is defined by the absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram (ECG), hematology, blood chemistry, coagulation, serology, and urinalysis. Some medical conditions are allowed that are well controlled by stable medication.
- •3. A body mass index (BMI) between 18.0 and 30.0 kg/m², inclusive
- •4. A body weight between 50 to 100 kg, inclusive
- •5. For women of reproductive potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures as defined below:
- •5.1. Women must remain abstinent or use contraceptive methods that result in a failure rate of <1% per year for at least 17 weeks after dosing.
- •5.2. A woman is considered to be of reproductive potential if she is postmenarcheal, has not reached a postmenopausal state (=12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). The definition of reproductive potential may be adapted for alignment with local guidelines or requirements.
- •5.3. Examples of contraceptive methods that result in a failure rate of <1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.
- •The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
- •9. Able to participate and willing to give written informed consent and to comply with the study restrictions
排除标准
- •1. History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer, or cirrhosis
- •2. History or suspicion of drug abuse and/or drug addiction
- •3. History or suspicion of alcohol abuse and/or alcohol addiction. Consumption of alcohol will not be allowed from 48 hours before dosing until the end of the residential period (Day 3) and should be limited to a maximum of 14 drinks per week for males and 7 drinks per week for females (1 drink = 12 g of pure alcohol) during the out-clinic period until follow-up.
- •4. Smokers who smoke more than 10 cigarettes per day or an equivalent amount of tobacco as determined by history. Healthy volunteers must be able to abstain from smoking from 48 hours before dosing until the end of the residential period (Day 3).
- •5. Pregnant or breastfeeding, or intending to become pregnant during the study or within 17 weeks after the last dose of study drug
- •6. Positive serum pregnancy test result at screening or Day -1 for women of childbearing potential
- •7. Known human immunodeficiency virus (HIV) infection or positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or HIV-1 antibody
- •8. Any familial history of early onset of AD
- •9. Participants who are >49 years of age with a MoCA score lower than 26
- •10. Confirmed (may use an average of =3 blood pressure measurements), supine systolic blood pressure (SBP) <90 mmHg or >140 mmHg or diastolic blood pressure (DBP) <50 mmHg or >90 mmHg at screening or Day -1
- •11. Pulse rate (PR) >90 beats per minute or <45 beats per minute (at screening only)
- •12. History or presence of clinically significant ECG abnormalities (e.g., PQ/PR interval > 220 milliseconds, Fridericia’s correction [QTcF] > 450 milliseconds) or cardiovascular disease (e.g., cardiac insufficiency, coronary artery disease, cardiomyopathy, congestive heart failure, family history of congenital long QT syndrome, family history of sudden death)
- •13. Use of prohibited medications or herbal remedies
- •14. Prior administration of gantenerumab
- •15. Clinically significant abnormalities (as judged by the investigator) in laboratory test results (including complete blood count, chemistry panel, and urinalysis)
- •16. Any major illness within 1 month before the screening examination or any febrile illness within 1 week prior to screening and up to the first administration of study drug 17. Impaired hepatic function as indicated by screening AST or ALT =3 × or total bilirubin =2 × the upper limit of normal (ULN)
- •18. Participation in an investigational drug medicinal product or medical device study within 30 days before dosing or within seven times the elimination half-life, whichever is longer
- •19. Donation of blood over 500 ml within 3 months before screening, for the duration of the study, and until 1 year after dosing
- •20. Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this stu
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