Bioavailability Study of Intranasal CT001 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- concentration of CT001 in the blood
研究概览
简要总结
A phase 1, three arms, cross over comparison study to evaluate bioavailability, pharmacokinetics and safety of intra nasal CT001 in healthy volunteers.
详细描述
A single site phase 1 study including a randomised, open label, three periods, single dose, cross over design in 12 healthy male volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age from 18 up to 55 years
- •Non-smokers
- •Body mass index (BMI) from 18.5 kg/m2 up to 30 kg/m2 v) Categorized as American Society of Anesthesiologists (ASA)
- •Physical Status Class 1 or 2
- •Clinically normal medical history, physical findings, vital signs, ECG and laboratory values.
排除标准
- •Mental illness
- •Opioid Risk Tool score of >3
- •Pain Catastrophizing Scale score, total points >30
- •Hospital Anxiety and Depression Scale (HADS), points ≥11 for anxiety or ≥11 points for depression
- •Daily intake of analgesics
- •History of alcohol or drug abuse or use of illicit drugs.
- •Use of prescription drugs within 14 days or over-the-counter drugs 24 hours (intranasal medication 48 hours) prior to the first dose of study medication.
- •Participant showing abnormal nasal cavity/airway
- •History or presence of allergy to the study drug or drugs of this class, or a history of drug or other allergy.
- •Positive tests for HIV, hepatitis B and hepatitis C
- •Positive COVID-19 test or clinical symptoms of COVID-19
- •Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 30 days of signing the informed consent for this trial
- •Blood donation within 4 weeks prior to the first dosing visit
研究组 & 干预措施
Investigational medicinal product CT001
intranasal dosage of CT001
干预措施: CT001 (Drug)
Comparator 1
Ketamine 10mg iv
干预措施: Ketamine (Drug)
Comparator 2
Sufentanil 10mcg iv
干预措施: sufentanil (Drug)
结局指标
主要结局
concentration of CT001 in the blood
时间窗: baseline, 3, 5, 10, 15, 30, 60, 90, 180, 240 minutes and 6, 9, 24, 32, 48 hours after dose
maximum concentration over time C(max),
Total amount of CT001 in the blood over time
时间窗: baseline, 3, 5, 10, 15, 30, 60, 90, 180, 240 minutes and 6, 9, 24, 32, 48 hours after dose
Area under the curve calculated from t=0 to t= 48 hours
次要结局
- distribution and elimination of CT001(baseline, 3, 5, 10, 15, 30, 60, 90, 180, 240 minutes and 6, 9, 24, 32, 48 hours after dose)
- number of study participants with adverse events(from baseline to 48 hours post dose)
- elimination of CT001(from baseline to 48 hours)
- vital signs(from baseline to 48 hours)