ACTRN12618001557224已完成1 期
A Phase 1, Open-Label, Single-Center Study Evaluating Absolute Bioavailability, Safety and Tolerability of Subcutaneous Formulation of RYI-018 Compared to Intravenous Formulation in Overweight and Obese Healthy Volunteers
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
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- All
入选标准
- •Healthy males and females of 18 to 45 years of age inclusive, at the time of signing the informed consent.
- •-Participants who give voluntary consent and those who are medically healthy with clinically insignificant screening results (e.g., laboratory profiles, medical history, ECGs, physical exam) as judged by the Investigator.
- •-BMI equal to, or greater than 25.0, but less than or equal to 40.0 (kg/m2)
- •-Participants should use highly effective, double barrier contraception (both male and female partners) during the study and 90 days following last dose of RYI-018. Male partners of female patients and female partners of male
- •-patients must also use contraception, if they are of childbearing potential.
- •-Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1. Females not of childbearing potential must be postmenopausal (defined as cessation of regular menstrual periods for at least 12 months), confirmed by follicle stimulating hormone (FSH) level >40 mIU/mL or surgically sterile.
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Medical Conditions -
- •1. Positive testing for, human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV).
- •2. Have any known malignancy or history of malignancy, except for basal cell skin cancer that has been treated with no evidence of recurrence for at least 3 months before Baseline.
- •3. History of cerebrovascular disease, coronary artery disease, seizures, major depression, suicidality, or unexplained syncope.
- •4. Have any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the participant will comply with the study.
- •5. Have evidence of any chronic medical condition (e.g., hypertension, asthma, or diabetes). Participants with a history of childhood asthma which is not currently active are allowed.
- •6. Active clinically significant infection within 7 days of Baseline.
- •7. Any acute illness, deemed clinically significant by Investigator, within 30 days prior to Baseline
- •8. History or presence of alcoholism or drug abuse within the 2 years prior to Baseline.
- •9. Surgery within the past three months prior to the first study intervention administration determined by the Investigator to be clinically relevant.
- •Prior/Concomitant Therapy -
- •10. Use of any prescription or over-the counter medication (with the exception of oral
- •contraceptives or paracetamol) within 7 days of Baseline.
- •Prior/Concurrent Clinical Study Experience
- •11. Administration of investigational product in another study within 30 days prior to
- •Diagnostic assessments -
- •12. Any clinically significant laboratory abnormality.
- •13. Aspartate aminotransferase (AST) or alanine transaminase (ALT) > upper limit of normal (ULN). One repeat test may be allowed within 7 days at the discretion of the Investigator.
- •Other Exclusions -
- •14. Positive urine drug screen/alcohol breathalyzer test at Screening and Day -1.
- •15. Smokers who have smoked more than the equivalent of 2 cigarettes (by declaration, including tobacco or nicotine products) within 6 months prior to Screening. No current use of any nicotine containing product. Cotinine test positive at Screening and Day -1.
- •16. Blood donation or significant blood loss within 60 days prior to Baseline.
- •17. Plasma donation within 7 days prior to Baseline.
- •18. Failure to satisfy the Investigator of fitness to participate for any other reason.
- •19. Females who are pregnant or lactating. Females should not breast feed for 6 months after last dose of RYI-018.
- •20. Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = 250 mL of beer, 25 mL of 40% spirit, or a 125-mL glass of wine) within 2 months prior to Screening.
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