A Phase 1, First-time-in-human, Dose Ascending Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MP0420 (a Novel Drug Candidate With Potential for Treatment of COVID-19) in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Vital Signs: Tympanic Temperature (°C)
研究概览
简要总结
This study will investigate how ensovibep is distributed throughout the body, the safety and the tolerability of ensovibep in healthy volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Part A only
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
- •Healthy male or female subjects between ages of 18-65 years
- •Body mass index of 18.0-35.0 kg/m2
- •Non-smokers for at least 3 months
- •Deemed healthy on the basis of a clinical history, physical examination, ECG, vital signs, and laboratory tests of blood and urine
- •Agree to follow the contraception requirements of the trial
- •Able to give fully informed written consent.
排除标准
- •Positive tests for hepatitis B & C, HIV
- •Severe adverse reaction to any drug
- •Drug or alcohol abuse
- •Use of over-the-counter medication (with the exception of paracetamol [acetaminophen]) during the 7 days before the first dose of trial medication, or prescribed medication during the 28 days before first dose of trial medication
- •Any vaccination within 4 weeks before dose of trial medication
- •Participation in other clinical trials of unlicensed medicines within the previous 3 months
- •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
- •Females who are pregnant or lactating, or who are sexually active and not using a reliable method of contraception.
研究组 & 干预措施
ensovibep dose 1 (infusion)
干预措施: Ensovibep (Drug)
ensovibep dose 2 (infusion)
干预措施: Ensovibep (Drug)
ensovibep dose 3 (infusion)
干预措施: Ensovibep (Drug)
placebo (infusion)
干预措施: Placebo (Drug)
ensovibep dose 4 (IV bolus)
干预措施: Ensovibep (Drug)
ensovibep dose 5 (IV bolus)
干预措施: Ensovibep (Drug)
ensovibep dose 6 (SC injection)
干预措施: Ensovibep (Drug)
ensovibep dose 7 (SC injection)
干预措施: Ensovibep (Drug)
ensovibep dose 8 (SC injection)
干预措施: Ensovibep (Drug)
ensovibep dose 9 (SC injection)
干预措施: Ensovibep (Drug)
ensovibep dose 10 (IM injection)
干预措施: Ensovibep (Drug)
ensovibep dose 11 (IM injection)
干预措施: Ensovibep (Drug)
ensovibep dose 12 (IM injection)
干预措施: Ensovibep (Drug)
ensovibep dose 13 (IM injection)
干预措施: Ensovibep (Drug)
结局指标
主要结局
Vital Signs: Tympanic Temperature (°C)
时间窗: up to day 100 (EOS)
Number of subjects with Laboratory Abnormalities
时间窗: up to day 100 (EOS)
Cardiac Safety assessed by 12-lead Electrocardiogram (ECG)
时间窗: up to day 100 (EOS)
Vital Signs: Blood Pressure Systolic and Diastolic (mmHg)
时间窗: up to day 100 (EOS)
Physical Examination
时间窗: up to day 100 (EOS)
For safety purpose, the following will be examined during full physical examinations: general appearance; head, ears, eyes, nose and throat; thyroid; lymph nodes; back and neck; heart; chest; lungs; abdomen; skin; and extremities; and the following systems will be assessed: musculoskeletal and neurological.
Vital Signs: Heart Rate (bmp)
时间窗: up to day 100 (EOS)
Vital Signs: Oxygen Saturation (SpO2%)
时间窗: up to day 100 (EOS)
Assessment of local tolerability
时间窗: up to day 100 (EOS)
Number of subjects with reaction at the injection site. The injection site is assessed for any pain, tenderness, erythema and induration.
Number of subjects with Adverse Events
时间窗: up to day 100 (EOS)
次要结局
- Time to Cmax (Tmax)(up to day 100 (EOS))
- The area under the serum concentration-time curve (AUC)(up to day 100 (EOS))
- Observed maximum concentration (Cmax)(up to day 100 (EOS))
- Apparent total body clearance of the drug from plasma (CL)(up to day 100 (EOS))
- The apparent volume of distribution during terminal phase after drug administration (Vz)(up to day 100 (EOS))
- Terminal Elimination Half-Life (T½)(up to day 100 (EOS))
- Proportion of subjects with treatment-emergent anti-drug antibodies (ADA)(up to day 100 (EOS))