A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose-escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Activity of MRG-110 Following Local Intradermal Injection After Skin Excisional Wound Creation in Normal Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.03.
研究概览
简要总结
MRG-110 is intended to promote the growth of new blood vessels by inhibiting a molecule called miR-92a. MRG-110 is being studied to determine if it can accelerate healing of wounds by improving blood flow into the wound area. The primary objective of this study is to investigate the safety and tolerability of MRG-110 when injected into the skin at the site of a small skin wound in normal healthy volunteers. Another objective is to study the pharmacokinetics of MRG-110 (the movement of a drug into, through and out of the body). Participants in the clinical trial will receive either a single dose or multiple doses of MRG-110 and/or placebo. Blood samples, urine samples and skin biopsies will be collected to measure how MRG-110 is processed by the body, and how the body responds when exposed to MRG-110.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal healthy volunteers.
- •Females must be of non-childbearing potential.
- •If engaged in sexual relations with a female of child-bearing potential, males must be surgically sterile or must be willing to use a highly effective method of contraception throughout their study participation and for at least 6 months after the last dose of study drug.
- •Must have 2 regions on lower back/upper buttocks that are free of striae, scars, tattoos, or other skin pathologies.
- •Must have no conditions that could increase risk of abnormal or delayed healing.
排除标准
- •Clinically significant abnormalities in medical history or physical examination.
- •Clinically significant abnormalities in laboratory tests at screening.
- •History of cutaneous disorder.
- •Hemangioma, history of hemangioblastoma, or other known vascular disorder.
- •Positive for bloodborne pathogen (hepatitis B, hepatitis C, HIV).
- •Use of an investigational drug or device within 28 days prior to Day 1, or use of an investigational biological or oligonucleotide drug within 90 days of Day 1.
研究组 & 干预措施
Single Ascending Dose - Placebo
Intradermal injection of placebo at four wound sites
干预措施: Placebo (Drug)
Single Ascending Dose - MRG-110
Intradermal injection of MRG-110 at two wound sites and intradermal injection of placebo at two other wound sites
干预措施: MRG-110 (Drug)
Single Ascending Dose - MRG-110
Intradermal injection of MRG-110 at two wound sites and intradermal injection of placebo at two other wound sites
干预措施: Placebo (Drug)
Multiple Ascending Dose - MRG-110
Intradermal injection of MRG-110 at two wound sites and intradermal injection of placebo at two other wound sites
干预措施: MRG-110 (Drug)
Multiple Ascending Dose - MRG-110
Intradermal injection of MRG-110 at two wound sites and intradermal injection of placebo at two other wound sites
干预措施: Placebo (Drug)
Multiple Ascending Dose - Placebo
Intradermal injection of placebo at four wound sites
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03.
时间窗: Up to Day 55
次要结局
- Area under the plasma concentration vs. time curve (AUC) of MRG-110 following single and repeat doses.(Up to Day 45)
- Peak plasma concentration (Cmax) of MRG-110 following single and repeat doses(Up to Day 45)