ACTRN12619000318189已完成1 期
Randomized, Double-Blind, Placebo-Controlled, Two-Part, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of KER-050 Administered to Healthy, Postmenopausal Women.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
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
- 45 Years 至 75 Years（—）
- 性别
- Female
入选标准
- •1.Postmenopausal* female, aged 45 to 75 years (inclusive) at screening. *NOTE: Postmenopausal is defined as:
- •12 months of spontaneous amenorrhea, OR 6 months of spontaneous amenorrhea with serum FSH levels greater than 40 IU/L;
- •6 weeks postsurgical bilateral oophorectomy with or without hysterectomy;
- •2.Non-smoker or social smoker who agrees to smoke 8 or less cigarettes per week or is willing to abstain from smoking/nicotine products during the study;
- •3.Weight range within 50 kg to 110 kg (inclusive);
- •4.In 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 that are assessed as not clinically significant by the Investigator.
排除标准
- •1.Clinically significant (as determined by the Investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease;
- •2.History of or current malignancy (excluding basal cell carcinoma that has been resected with no evidence of metastatic disease for 3 years);
- •3.Chronic stable diseases including frequent migraines, type 2 diabetes, hypertension, hyperthyroid disorder, hypothyroid disorder, gastroesophageal reflux disease, or mild depression/anxiety;
- •4.Current opportunistic infection (eg, invasive candidiasis or pneumocystis pneumonia);
- •5.Serious local infection (eg, cellulitis, abscess) or systemic infection (eg, septicemia) within the 3 months prior to screening;
- •6.History of severe allergic or anaphylactic reactions;
- •7.Surgery within 3 months prior to screening (other than minor cosmetic surgery or minor dental procedures);
- •8.Fever (body temperature greater than 38°C) or symptomatic viral or bacterial infection within 2 weeks prior to screening that has not resolved prior to dosing;
- •9.Clinically relevant/significant laboratory findings (up to 2 repeats permitted) at screening including, but not limited to:
- •Alanine transaminase and aspartate transaminase greater than or equal to 1.2 times the 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 greater than 1.5 times the ULN;
- •10.Donated blood (1 unit or more) within 1 month prior to dosing or plans to donate blood during the study;
- •11.Recent hormone replacement therapy, within 3 months prior to dosing or plans to begin hormone replacement therapy at any time during the study. Estrogen replacement is permitted;
- •12.Received systemic glucocorticoid therapy for more than 1 month within 6 months before screening;
- •13.Changes in medications that may affect muscle function (e.g. statins, beta-blockers, etc.) within 3 months prior to dosing;
- •14.Positive screen for alcohol and/or potential drugs of abuse (cannabis and metabolites, cocaine and metabolites, amphetamines, barbiturates, benzodiazepines and/or opioids) by urine drug screen at screening and Day -1. Up to 1 repeat permitted;
- •15.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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