NCT05238207终止1 期
A Phase Ia/Ib Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacodynamics of BBI-001 in Iron Deficient Volunteers and HH Patients
Bond Biosciences1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年3月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Adverse Events (AE)
研究概览
简要总结
This is a first in human, double-blind, randomized, placebo-controlled, two-arm crossover study evaluating the safety, tolerability and PD of ascending dose levels of BBI-001 after:
- a single administration in iron deficient male and female participants, and male and female HH patients (Part A),
- two administrations per day in HH patients (Part B). BBI-001 administrations will be accompanied with consumption of a meal enriched with stable iron isotope Fe57, while corresponding placebo dose administrations will be with a meal enriched with stable iron isotope Fe58.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Otherwise healthy iron deficient participants or patients with hereditary hemochromatosis
排除标准
- •Serious or unstable medical or psychiatric conditions
- •Significant medical history
- •Current infections
- •Receiving iron chelation therapy or treatment other than stable maintenance phlebotomy for the prior 6 months
- •Organ damage from iron overload in the view of the PI would prevent successful completion of the protocol
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo: Oral administration immediately prior to a meal enriched with stable iron isotope Fe58
干预措施: Original Fibre Metamucil (Dietary Supplement)
BBI-001
Experimental
BBI-001: Oral administration immediately prior to a meal enriched with stable iron isotope Fe57
干预措施: BBI-001 (Drug)
结局指标
主要结局
Adverse Events (AE)
时间窗: up to 17 days
Incidence, type, and severity of AEs, to include clinically significant laboratory changes
Clinical Laboratory Testing - Iron Panel
时间窗: up to 17 days
Changes from baseline in iron panel
次要结局
- Evaluation of Iron Isotope Blood Levels(up to 17 days)
研究者
研究点 (1)
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