A Randomized, Double-blind, Placebo-controlled Exploratory Clinical Study to Evaluate the Safety and Tolerability of SPOT-mRNA01 Injection in Healthy Adult Subjects.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 主要终点
- Assessment of the frequency and severity of AEs caused by SPOT-mRNA01
研究概览
简要总结
This is a first-in-human, randomized, double-blind, placebo-controlled clinical study to evaluate the Safety and Tolerability of SPOT-mRNA01 injection in healthy adult volunteers.
详细描述
SPOT-mRNA01 (collagen 1 alpha 1 (COL1A1) mRNA-loaded by Extracellular vesicles （EVs）) can induce collagen protein grafts in dermal tissue, thereby supplementing collagen and reducing wrinkle formation in collagen-depleted skin. Therefore, SPOTmRNA01 can provide a source of human collagen intradermally for cosmetic anti-aging use.
This is a first-in-human randomized, double-blind, placebo-controlled, single-dose, dose ascending, exploratory clinical study to evaluate the Safety and Tolerability of SPOT-mRNA01 administered by subcutaneous injection to healthy adult volunteers.
Biopsies will be used to detect the expression of collagen in the skin of the injection area.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 to 75 years inclusive at the time of informed consent.
排除标准
- •Any transient or chronic skin condition, disorder, or infection within 20 cm of the target areas before treatment that, in the opinion of the investigator, may confound study results.
- •History of laser treatment or chemical peels or any cosmetic anti-aging treatments to the target areas within six months of the study treatment.
- •History of surgical procedures to target areas, including removal of benign or malignant skin cancers that, in the opinion of the investigator, may confound study results.
- •Participant with a history of heavy smoking, alcohol or drug abuse or steroid treatment.
- •Pregnant or breast-feeding females.
- •History of anaphylaxis or allergic reactions to any constituent of the study product and/or local anesthetics, and/or history of severe abnormal drug reaction.
- •Those who have participated in clinical trials of other investigational drugs within 3 months before the study treatment.
- •Those who are not suitable for subcutaneous injection and biopsy.
- •Any condition that the investigator or primary physician believes may not be appropriate for participating the study.
研究组 & 干预措施
SPOT-mRNA01
SPOT-mRNA01 (COL1A1 mRNA-loaded by EVs)
干预措施: SPOT-mRNA01 (Biological)
Placebo
Sterile isotonic solution
干预措施: Placebo (Other)
结局指标
主要结局
Assessment of the frequency and severity of AEs caused by SPOT-mRNA01
时间窗: 3 months
The investigator will collect a description of the events, time of onset and resolution, assessment of severity and causal relationship to SPOT-mRNA01.
次要结局
- level of COL1A1 protein expression in local dermal tissue after subcutaneous injection of SPOT-mRNA01(Days 4, 7 and 31)
- Assessment of skin thickness after subcutaneous injection of SPOT-mRNA01(Baseline and days 7， 15， 31， 61 and 91)