NCT04072861已完成1 期
A Phase 1b Dose-escalating Study With RBT-9 in Healthy Volunteers and Volunteers With Chronic Kidney Disease Stage 3/4
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Effect of RBT-9 on Plasma Ferritin Levels
研究概览
简要总结
This is a Phase 1b, single-center, dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic effect of RBT-9 in healthy volunteers and in subjects with Stage 3/4 CKD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects age 18 to 80 years (inclusive, at time of ICF).
- •Body weight <125 kg.
- •Able and willing to comply with all study procedures.
- •Female subjects must be either post-menopausal for at least 1 year or surgically sterile (tubal ligation, hysterectomy or bilateral oophorectomy) for at least 3 months, or if of childbearing potential, have a negative pregnancy test and agree to use dual methods of contraception, or abstain from sexual activity from Screening until 28 days after study drug administration.
- •Male subjects with female partners of childbearing potential must agree to use a highly effective method of contraception from screening until 28 days after study drug administration. All fertile men with female partners of childbearing potential should be instructed to contact the Investigator immediately if they suspect their partner might be pregnant (e.g., missed or late menstrual period) at any time during study participation.
- •CKD stage 3 as determined by a GFR between 30-59 ml/min as estimated using the CKD-EPI equation.
- •CKD stage 4 as determined by a GFR between 15-29 ml/min as estimated using the CKD-EPI equation.
排除标准
- •History of malignancy, except carcinoma in situ in the cervix, early stage prostate cancer or non-melanoma skin cancers. Cancer free for less than 5 years.
- •Use of investigational drugs or participation in another clinical trial within 30 days or 5 half-lives prior to Screening, whichever was longer.
- •Serum ferritin >500 ng/mL or received IV iron within 28 days of Screening.
- •Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study.
- •Any significant acute or chronic diseases, excluding CKD (≥ 15 ml/min); if CKD is present, those not at their baseline of renal function.
- •Abnormal Baseline liver tests or hepatitis serologies that suggest active infection.
- •Regular use of drugs of abuse and/or positive findings on urinary drug screening.
- •Current tobacco use and/or positive findings on urinary cotinine screening.
- •Severely physically or mentally incapacitated and who, in the opinion of Investigator, are unable to perform the subjects' tasks associated with the protocol.
- •Presence of any condition which, in the opinion of the Investigator, places the subject at undue risk or potentially jeopardizes the quality of the data to be generated.
- •History of photosensitivity or active skin disease which, in the opinion of the Investigator, could increase the risk of photosensitivity.
- •Known hypersensitivity or previous anaphylaxis to RBT-9 or tin-based product.
研究组 & 干预措施
9 mg
Experimental
干预措施: RBT-9 (Drug)
27 mg
Experimental
干预措施: RBT-9 (Drug)
90 mg
Experimental
干预措施: RBT-9 (Drug)
结局指标
主要结局
Effect of RBT-9 on Plasma Ferritin Levels
时间窗: 24 hours post-infusion
Percent Change in Plasma Ferritin From Baseline to 24 hours
Effect of RBT-9 on Plasma IL-10 Levels
时间窗: 24 hours post-infusion
Percent Change in Plasma IL-10 From Baseline to 24 hours
Effect of RBT-9 on Plasma HO-1 Levels
时间窗: 24 hours post-infusion
Percent Change in Plasma HO-1 From Baseline to 24 hours
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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