NCT05277922已完成1 期
A Phase 1, Open-label, Single-centre Study Investigating the Effect of C21 on Forearm Blood Flow in Healthy Male Subjects by Use of Strain-gauge Venous Occlusion Plethysmography
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Percentage Change From Baseline in Forearm Blood Flow in Response to Increasing Intraarterial Doses of C21
研究概览
简要总结
The purpose of this study is to assess the effect of C21 on forearm blood flow by use of strain-gauge venous occlusion plethysmography.
详细描述
Subject will be screened for eligibility. Eligible subjects will receive ascending doses of C21 (3, 10, 30, 100, and 200 µg/min through local intra-arterial infusions for 5 min/dose. Forearm blood flow measurements will be performed in both arms during the last 2 minutes of each dose.
Infusions of sodium nitroprusside will be performed as a positive control using the same methodology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Willing and able to give written informed consent for participation in the study and to comply with study requirements.
- •Healthy male subject aged 18-45 years
- •Body mass index ≥ 18.5 and ≤ 30.0 kg/m
- •Wlling to use condom or be vasectomised or practice sexual abstinence
- •Clinically normal medical history, physical findings, vital signs, ECG and laboratory values
排除标准
- •History of any clinically significant disease or disorder which may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
- •History of thrombotic disease, vascular disorder, or severe bleeding disease.
- •Poor brachial artery access.
- •Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of baseline
- •Malignancy within the past 5 years with the exception of basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
- •Any planned major surgery within the duration of the study.
- •Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and human immunodeficiency virus (HIV).
- •Abnormal vital signs
- •Prolonged QT interval, cardiac arrhythmias or any clinically significant abnormalities in the resting ECG
- •History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity or history of hypersensitivity to drugs with a similar chemical structure or class to the IMPs, including any of the excipients of the IMPs.
- •Regular use of any prescribed or non-prescribed medication including antacids, analgesics, herbal remedies, vitamins, and minerals
- •Regular use of non-steroidal anti-inflammatory drugs or acetylsalicylic acid
- •Vaccination within 1 week prior to dosing or plans to receive any vaccine during the study conduct.
- •Planned treatment or treatment with another investigational drug within 3 months
- •Current regular smokers or users of nicotine products.
- •History of alcohol abuse
- •Presence or history of drug abuse
- •Positive screen for drugs of abuse or alcohol at screening
- •History of, or current use of, anabolic steroids.
- •Inability to refrain from consuming caffeine-containing beverages during Day 1
- •Plasma donation within 1 month of screening or blood donation (or corresponding blood loss) during the 3 months prior to screening.
- •Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements.
研究组 & 干预措施
C21 combined
Experimental
15 µg C21 (infusion rate 3 µg/min) 50 µg C21 (infusion rate 10 µg/min) 150 µg C21 (infusion rate 30 µg/min) 500 µg C21 (infusion rate 100 µg/min) 1000 µg C21 (infusion rate 200 µg/min)
干预措施: C21 (Drug)
Positive control
Experimental
4 µg nitroprusside (infusion rate 0.8 µg/min) 8 µg nitroprusside (infusion rate 1.6 µg/min) 16 µg nitroprusside (infusion rate 3.2 µg/min)
干预措施: Sodium Nitroprusside (Drug)
结局指标
主要结局
Percentage Change From Baseline in Forearm Blood Flow in Response to Increasing Intraarterial Doses of C21
时间窗: 85 minutes
Percentage change from baseline in forearm blood flow (FBF) in response to increasing intraarterial doses of C21 (3, 10, 30, 100, and 200 μg/min)
次要结局
- Dose-response Curve of C21 on Forearm Blood Flow (FBF)(85 min)
- Percentage Change From Baseline in Forearm Blood Flow in Response to Increasing Intra-arterial Doses of Sodium Nitroprusside(45 minutes)
- Frequency of Adverse Events(Day 1-7)
- Number of Mild, Moderate, and Severe Adverse Events(Day 1-7)
- Number of Serious Adverse Events (SAEs)(Day 1-7)
- Number of Participants With Clinically Significant Changes in Vital Sign Parameters(5 hours)
- Number of Participants With Clinically Significant Changes in ECG Parameters(5 hours)
- Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters(5 hours)
研究者
研究点 (1)
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