Double-blind, Placebo-controlled Dose-escalation Phase I Study With Recombinant Human Soluble Angiotensin Converting Enzyme 2 (rhACE2) APN01 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Safety and tolerability profile of APN01 when administered as a single dose / multiple dose i.v. in healthy volunteers. Measures: Blood chemistry, Hematology, Urinalysis, Adverse events, Vital signs including blood pressure, pulse, respiratory rate, ECG
研究概览
简要总结
The purpose of this study is to define the dose for a Phase II study and to investigate safety and tolerability of intravenous administration of recombinant soluble human Angiotensin Converting Enzyme 2 in healthy volunteers.
详细描述
APN01-1-01 is a placebo controlled double blinded Phase I study composed of a single dose, dose escalation part followed by a multiple dosage part. The first four cohorts (four individuals each) will receive 100, 200, 400 and 800 µg/kg APN01 i.v. or placebo. Cohorts 5 and 6 (three individuals each) will receive three and six i.v. APN01 administrations daily, respectively. Planned dosage of the multiple dose part will be 400 µg/kg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female
- •Age ≥18 years
- •Use of acceptable form of birth control
- •Willing to comply with study protocol
- •No significant background illness
- •Signed informed consent form
排除标准
- •Significant hematological, renal, hepatic, metabolic, psychiatric or pulmonary diseases.
- •Heart disease or elevated blood pressure.
- •Any other significant disease that could interfere with the subject's ability to complete the protocol
- •History of alcohol or drug abuse
- •Abnormal urinalysis
- •Pregnant or lactating female subjects
- •Use of anticoagulants or antihypertensive drugs, particularly drugs interfering with the renin-angiotensin-aldosterone system, Obesity or anorexia (BMI <18 or >30)
- •History of malignancy, except basal cell carcinoma of the skin, Known history of human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection or positive serology testing in the study screening procedures (except indicating immunization)
- •Participation in a clinical trial within the last 30 days
- •Any of the following laboratory abnormalities:
- •WBC 15% outside of normal limits
- •Hemoglobin 15% outside of normal limits
- •Platelets 15% outside of normal limits
- •Aspartate transferase (AST) or alanine transferase (ALT) above 15% outside of normal limits
- •Alkaline phosphatase above 15% outside of normal limits
- •Urea above 15% outside of normal limits
- •Creatinine above 15% outside of normal limits.
结局指标
主要结局
Safety and tolerability profile of APN01 when administered as a single dose / multiple dose i.v. in healthy volunteers. Measures: Blood chemistry, Hematology, Urinalysis, Adverse events, Vital signs including blood pressure, pulse, respiratory rate, ECG
时间窗: 31 Days
次要结局
- To obtain pharmacokinetic and pharmacodynamic data for APN01 and to investigate potential immunogenicity of APN01. Measures: Systemic rhACE2 concentration and activity, potential humoral immune response, Angiotensin II and Angiotensin 1-7 plasma levels.(31 days)