A Phase 1, Randomized, Double-Blinded, Placebo-controlled, Single and Multiple-Ascending Dose Study of the Safety, Tolerability, Food Effect, Pharmacokinetics, and Pharmacodynamics of BBP-711 (ORF-229) in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Safety and Tolerability
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of BBP-711 in healthy adult volunteers.
详细描述
This is a single-center, two-part, randomized, double-blinded, placebo-controlled, ascending dose study of BBP-711 in healthy male and female adult volunteers. The purpose of this study is to evaluate the safety and tolerability of BBP-711 in healthy adult volunteers. Each volunteer will participate in the study for about 20 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Adult male or female who is 18 to 65 years old,
- •Weight >50 kg and ≤110 kg at Screening
- •Body mass index (BMI) 20 to 32 kg/m2, inclusive, at Screening
- •In generally good health
- •Nonsmoker, or not using tobacco or nicotine-containing products for at least 6 months
排除标准
- •Use of any over-the-counter medications, including herbals or routine vitamins or minerals, or other supplements, within 7 days before admission to the research center.
- •Pregnant or breastfeeding
- •eGFR <90 mL/minute
- •Abnormal ECG
- •Abnormal laboratory results
- •Positive test result for HIV, Hepatitis B, Hepatitis C, or COVID-19
- •History of substance dependency (alcohol or other drugs of abuse) in the last 2 years
- •Use of study drug in any clinical trial within 30 days of admission to the research center, or in the active follow-up phase of another clinical trial involving study drug
研究组 & 干预措施
BBP-711 for SAD
A single dose of BBP-711 will be administered orally.
干预措施: BBP-711 (Drug)
Placebo for SAD
A single dose of matching placebo will be administered orally.
干预措施: Placebo (Drug)
BBP-711 for MAD
A dose of BBP-711 will be administered orally for multiple days.
干预措施: BBP-711 (Drug)
Placebo for MAD
A dose of matching placebo will be administered orally for multiple days.
干预措施: Placebo (Drug)
BBP-711 for SAD Food Effect
A single dose of BBP-711 will be administered orally.
干预措施: BBP-711 (Drug)
Placebo for SAD Food Effect
A single dose of matching placebo will be administered orally.
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and Tolerability
时间窗: Baseline to Day 20
Incidence of Adverse Events (AEs)
次要结局
- Pharmacodynamic Assessment: Percentage change from baseline plasma glycolate(Blood samples will be taken pre-dose up to Day 10 for SAD and pre-dose up to Day 20 for MAD)
- Pharmacokinetic Assessments: Cmax(Blood samples will be taken pre-dose up to Day 10 for SAD and pre-dose up to Day 20 for MAD)
- Pharmacokinetic Assessments: Cmin(Blood samples will be taken pre-dose up to Day 10 for SAD and pre-dose up to Day 20 for MAD)
- Pharmacokinetic Assessments: AUC(Blood samples will be taken pre-dose up to Day 10 for SAD and pre-dose up to Day 20 for MAD)
- Pharmacodynamic Assessment: Baseline plasma glycolate(Baseline)
- Pharmacodynamic Assessment: Baseline 24 Hour urinary glycolate:creatinine ratio(Baseline)
- Pharmacodynamic Assessment: Percentage change from baseline of 24 Hour urinary glycolate:creatinine ratio(Urine samples will be taken pre-dose up to Day 3 for SAD and pre-dose up to Day 7 for MAD)