ACTRN12619000319178已完成1 期
Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KER-047 Administered to Healthy Male Volunteers and Postmenopausal Female Volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 131
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
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 60 Years（—）
- 性别
- All
入选标准
- •Male Subjects:
- •1. 18 to 60 years old (MAD Cohorts 4, 5 & 6: 50 years) (inclusive) at screening;
- •2. Good health as determined by review of medical history, physical examination, vital signs, oxygen saturation, clinical laboratory tests, 12-lead ECG, and any abnormal findings are assessed as not clinically significant by the Investigator;
- •3. Non-smoker or social smokers who agrees to smoke less than or equal to 8 cigarettes per week or willing to abstain from smoking/nicotine products during the study;
- •4. Body weight between 50 and 110 kg inclusive and body mass index (BMI) between 18 and 32 kg/m2 (inclusive) at screening;
- •Female Subjects:
- •1. Postmenopausal female aged 45 to 60 years (MAD Cohorts 4, 5 & 6: 50 years) (inclusive) at screening;
- •2. Good health as determined by review of medical history, physical examination, vital signs, oxygen saturation, clinical laboratory tests, 12-lead ECG, and any abnormal findings are assessed as not clinically significant by the Investigator;
- •3. Non-smoker or social smokers who agrees to smoke less than or equal to 8 cigarettes per week or willing to abstain from smoking/nicotine products during the study;
- •4. Body weight between 50 and 100 kg (inclusive) and BMI between 18.5 and 32 kg/m2 (inclusive) at screening.
排除标准
- •1. History of or current malignancy (excluding non-melanoma skin cancer that has been resected with no evidence of metastatic disease for 3 years);
- •2. Use of any prescription or over-the-counter medications taken within 7 days prior to dosing should be discussed with Investigator and Sponsor Medical Monitor (if deemed necessary). Use of medication should be ceased prior to dosing. Subject may be enrolled if the medication taken is not expected to interfere either with safety or study results;
- •3. Clinically significant (as determined by the Investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease;
- •4. Chronic stable diseases including migraines, hypertension, hyperthyroid disorder, hypothyroid disorder, gastroesophageal reflux disease, or mild depression/anxiety ;
- •5. History of opportunistic infection (e.g. invasive candidiasis or pneumocystis pneumonia);
- •6. Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., septicemia) within the 3 months prior to screening;
- •7. History of severe allergic or anaphylactic reactions;
- •8. Surgery within the previous 3 months to screening (other than minor cosmetic surgery or minor dental procedures);
- •9. Fever (body temperature > 38°C) or symptomatic viral or bacterial infection within 2 weeks prior to screening that has not resolved prior to dosing;
- •10. Clinically relevant/significant laboratory findings (up to 2 repeats permitted) at screening including, but not limited to:
- •Alanine transaminase and Aspartate transaminase > 1.0 x upper limit of normal (ULN), isolated and mainly unconjugated hyperbilirubinemia consistent with Gilbert's should not be excluded;
- •Creatinine outside normal laboratory range;
- •Serum creatine kinase > 1.5 x ULN;
- •11. Treatment with another investigational drug, investigational device, or approved therapy for investigational use within 1 month or 7 half-lives prior to dosing.
研究者
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