A Single-centre, Double-blind, Placebo-controlled, Study in Healthy Men to Assess the Safety and Tolerability of Single and Repeated Ascending Doses of MGB-BP-3
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- To assess the safety and tolerability of single and repeated oral doses of MGB-BP-3 in healthy men
研究概览
简要总结
This study is to assess the safety and tolerability aspects of oral MGB-BP-3, a treatment for Clostridium difficile infections.
详细描述
Short Title: Safety, blood levels and effects of MGB-BP-3
Trial medication MGB-BP-3 is a new class of antibacterial agent that binds selectively to the bacterial DNA minor groove and possesses strong bactericidal in vitro and in vivo activity against Clostridium difficile (C. difficile). In addition to its activity against C. difficile MGB-BP-3 has very strong activity against all other Gram-positive bacteria tested, including susceptible and resistant Staphylococcus aureus, Streptococcus and Enterococcus.
MGB-BP-3 is being developed for the treatment of C. difficile infections (CDI).
Objectives Primary: To assess the safety and tolerability of single and repeated oral doses of MGB-BP-3 in healthy men Secondary: To assess the pharmacokinetics (PK) of single and repeated oral doses of MGB-BP-3 in healthy men
Type of trial This trial will be done in 2 parts, as follows. Part A: Phase I, double-blind, randomised, placebo-controlled, crossover, single ascending-dose trial in healthy men.
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
- Male
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) of 18.0-30.9 kg/m2
- •Normal blood pressure
- •healthy on the basis of a clinical history & physical examination
- •Normal ECG
- •Normal vital signs
- •Normal laboratory tests of blood and urine
- •Willing to use reliable contraception
- •Able to give fully informed written consent
排除标准
- •Positive tests for hepatitis B & C
- •Positive tests for HIV
- •Severe adverse reaction to any drug
- •Drug or alcohol abuse
- •Smoke more than 5 cigarettes (or use of equivalent tobacco or nicotine products) daily
- •Received over-the-counter medication within previous 7 days (with the exception of paracetamol)
- •Prescribed medication during previous 28 days
- •Participation in other clinical trials of unlicensed medicines
- •Loss of more than 400 mL blood, within the previous 3 months
- •Vital signs outside the acceptable range
- •Clinically relevant abnormal findings at the screening assessment
- •Acute or chronic illness
- •Clinically relevant abnormal medical history or concurrent medical condition
- •Possibility that volunteer will not cooperate.
研究组 & 干预措施
Group 1, Session 1, Active
Lowest dose of SAD:
MGB-BP-3, 250 mg liquid filled enterically coated capsule, single dose
干预措施: MGB-BP-3 (Drug)
Group 1, Session 2, Active
Dose Escalation SAD:
MGB-BP-3, 2X250 mg liquid filled enterically coated capsule, single dose
干预措施: MGB-BP-3 (Drug)
Group 1, Session 3, Active
Dose Escalation SAD MGB-BP-3, 3X250 mg liquid filled enterically coated capsules, single dose
干预措施: MGB-BP-3 (Drug)
Group 2, Session 1, Active
Dose Escalation SAD MGB-BP-3, 4X250 mg liquid filled enterically coated capsules, single dose
干预措施: MGB-BP-3 (Drug)
Group 2, Session 2, Active
Dose Escalation SAD MGB-BP-3, 5X250 mg liquid filled enterically coated capsules, single dose
干预措施: MGB-BP-3 (Drug)
Group 2, Session 3, Active
Dose Escalation SAD MGB-BP-3, 6X250 mg liquid filled enterically coated capsules, single dose
干预措施: MGB-BP-3 (Drug)
Group 3, Active
Lowest dose of MAD MGB-BP-3, 2X250 mg liquid filled enterically coated capsules (AM/PM), multiple dose for 9 days and 1 single dose on Day 10
干预措施: MGB-BP-3 (Drug)
Group 4, Active
Dose Escalation MAD MGB-BP-3, 4X250 mg liquid filled enterically coated capsules (2XAM/2XPM), multiple dose for 9 days and 1 single dose on Day 10
干预措施: MGB-BP-3 (Drug)
Group 5, Active
Dose Escalation MAD MGB-BP-3, 8X250 mg liquid filled enterically coated capsules (3XAM/3XPM), multiple dose for 9 days and 1 single dose on Day 10
干预措施: MGB-BP-3 (Drug)
Group 1, Session 1, Placebo
Lowest dose of SAD:
Placebo, 1 liquid filled enterically coated capsule, single dose
干预措施: Placebo (Other)
Group 1, Session 2, Placebo
Placebo, 2 liquid filled enterically coated capsules, single dose
干预措施: Placebo (Other)
Group 1, Session 3, Placebo
Placebo, 3 liquid filled enterically coated capsules, single dose
干预措施: Placebo (Other)
Group 2, Session 1, Placebo
Placebo, 4 liquid filled enterically coated capsules, single dose
干预措施: Placebo (Other)
Group 2, Session 2, Placebo
Placebo, 5 liquid filled enterically coated capsules, single dose
干预措施: Placebo (Other)
Group 2, Session 3, Placebo
Placebo, 6 liquid filled enterically coated capsules, single dose
干预措施: Placebo (Other)
Group 3, Placebo
Placebo 2 liquid filled enterically coated capsules (AM/PM), multiple dose for 9 days and 1 single dose on Day 10
干预措施: Placebo (Other)
Group 4, Placebo
Placebo 4 liquid filled enterically coated capsules (2XAM/2XPM), multiple dose for 9 days and 1 single dose on Day 10
干预措施: Placebo (Other)
Group 5, Placebo
Placebo 8 liquid filled enterically coated capsules (3XAM/3XPM), multiple dose for 9 days and 1 single dose on Day 10
干预措施: Placebo (Other)
结局指标
主要结局
To assess the safety and tolerability of single and repeated oral doses of MGB-BP-3 in healthy men
时间窗: 4 months
Safety Assessment - Composite Metrics: vital signs, ECG, telemetry (Part A only), physical examination, laboratory safety tests, faecal occult blood, intestinal permeability (absorptive capacity test using differential sugar absorption with the urine sugars measured using LC-MS, Part B only), faecal flora (Part B only) and Tolerability (AE's \& SAE's)
次要结局
- To assess the pharmacokinetics (PK) of single and repeated oral doses of MGB-BP-3 in healthy men(4 months)