A Randomized, Double-Blind, Placebo-Controlled, Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of BMB-101 in Fed and Fasted Adult Healthy Human Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Number of Treatment-emergent Adverse Events
研究概览
简要总结
This study is designed as a single centre, double blind, placebo controlled, randomized, SAD/FE/MAD, safety, tolerance and PK study of BMB-101 in healthy adult subjects. The study will be conducted as a 3-part study.
详细描述
This study is designed as a 3-part study:
Part 1 is designed as single ascending dose (SAD) escalation study investigating 4 dose levels. Each cohort will consist of participants to be randomly assigned to receive a blinded oral dose of BMB-101 or placebo.
Part 2 is designed as a randomized, orally administered, single-dose, two-treatment (fed vs fasted), two-period, two-sequence crossover to assess the effects of a standard high-fat breakfast on PK of BMB-101.
Part 3 is designed as a multiple ascending dose (MAD) escalation study investigating up to 4 dose levels. Subjects will be randomized to receive double-blind treatment of BMB-101 or matching placebo twice daily for 7 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject must be aged between 18 and 55 years (both inclusive).
- •Healthy subjects with no clinically significant screening results.
- •Body mass index (BMI) 18.0 to 32.0 kg/m².
- •Males and non pregnant females willing to use contraceptives consistent with local regulations from screening through 3 months after the last dose of study medication.
- •Agree to frequent blood and urine sampling during the course of the study.
- •Agree to be confined in the study unit and follow study procedures.
排除标准
- •Subjects with unstable or severe illness as indicated on medical history, physical examination, or clinical laboratory, vital signs, and electrocardiograms (ECGs) evaluations, or in the opinion of the Investigator.
- •Subjects with reported history within past 6 months of, or current treatment for, any GI disease that may impact the absorption of an oral drug for example gastroesophageal reflux disorder, peptic ulcer disease, inflammatory bowel disease.
- •Subjects with a history of seizures other than febrile seizures as a child.
- •Subjects with history of or current glucose intolerance; or with history of gestational diabetes.
- •Subjects with lifetime history of suicidal behavior or with lifetime history of suicidal ideation as indicated by the Columbia-Suicide Severity Rating Scale (C-SSRS)
- •Subjects with any use of or intent to use any medications, including prescription, over-the-counter (OTC), herbal preparations, or vitamin/mineral supplementation, other than study medications, from 7 days prior to first dose through follow-up visit.
- •Female subjects with a positive pregnancy test at Screening or Day -1 or who are breastfeeding.
- •Subjects who have used more than 5 cigarettes, cigars, or nicotine-containing products per month within 6 months prior to first study dose, or plan to use them through completion of the follow-up visit.
- •Subjects with a positive drug screen for illegal drugs including cannabis at Screening or Day -1.
研究组 & 干预措施
Placebo
Participants receiving Matched Placebo orally
干预措施: Placebo (Drug)
BMB-101
Participants receiving BMB-101 orally
干预措施: BMB-101 (Drug)
结局指标
主要结局
Number of Treatment-emergent Adverse Events
时间窗: Baseline up to Follow Up/End of Treatment visit, an average of 8 months.
Incidence and severity of adverse events, including serious adverse events and adverse events, clinically significant changes in laboratory testing, vital signs, Holter monitoring, physical examination, and ECGs
Change in Columbia-Suicide Severity Rating Scale (C-SSRS) Response
时间窗: Administered at each of the following visits in Part 3: Screening, Clinic Discharge, and Follow-up/Early Withdrawal.
Type of Suicidal Ideation, Intensity (1 - 5, with 5 being most severe), Suicidal Behavior
次要结局
- Pharmacokinetic Assessment(Day 1 through End of Dosing Period.)