ACTRN12623000204640已完成1 期
A Phase Ib Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ALG-801 in Postmenopausal Women
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
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
- •Subject is postmenopausal
- •-Body mass index (BMI) between 18.5 and 35 kg/m2 (inclusive)
- •-Free from clinically significant unstable medical problems as determined by the Investigator, and if medicated, the medication does not interfere with the investigational product
排除标准
- •-Hospitalization within the 3 months prior to the first dose of study treatment
- •-Has an established diagnosis of diabetes mellitus, as indicated by use of diabetes medication, Hb A1C greater than 6.4% or fasting glucose equal to 126 mg/dL (7.0 mmol/L)
- •-Positive test for drugs of abuse (including recreational drugs) at screening and admission to the research unit
- •-Receipt of an investigational study to evaluate pharmaceuticals or biologics within the past 1 month or 5 half-lives, whichever is longer
- •-Prior treatment with any ActRIIA- or ActRIIB-related ligand trap, such as KER-12, KER-50, ACE-536 (Luspatercept), ACE-011 (Sotatercept) and ACE-031
- •-History of any malignant cancer during the past 5 years, except treated nonmelanotic skin cancer or carcinoma in situ of the uterine cervix
- •-History of a major adverse cardiovascular event during the past 6 month
- •-History of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, autoimmune diseases, dermatologic, neurologic, oncologic, psychiatric disease (except for mild depression and anxiety)
- •-History of opportunistic infection within 6 months prior to screening or serious local infection or systemic infection within 3 months prior to screening
- •-Major surgery within 12 weeks prior to Day 1, except for minor cosmetic or dental procedures.
- •-Fever or symptomatic infection (viral or bacterial) within 7 days prior to Day 1
- •-Blood donation or significant blood loss (480mL or more) within 30 days prior to Day 1
- •-Hormone replacement therapy within 12 weeks prior to Day 1; infrequent use of estrogen vaginal creams (less than 3 times per week) is allowed
- •-Anti-osteoporosis medications (e.g., bisphosphonates, denosumab, teriparatide, romosozumab, etc.) within 28 days of first dosing or within 5 times the elimination half-life of the medication prior to first dosing, whichever is longer
- •-Systemic glucocorticoid therapy within 6 months prior to Day 1
- •-Protein supplements or nutritional supplements for muscle building or supplements which contain anabolic or ergogenic substances (e.g., creatine) within 28 days of first dosing
- •-History of significant bleeding disorder or known disease involving platelet number and/or function
研究者
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