A Phase 1 Randomized, Placebo-Controlled, Blinded Study Evaluating the Safety, Tolerability, and Pharmacokinetics of ARC-001 in Participants Undergoing Third Molar Extraction
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Safety and Tolerability
研究概览
简要总结
The study will test the investigational product gel against placebo (which contains no active ingredient) to determine if it is safe after wisdom tooth extraction. The main questions the study will answer are:
- How much of the investigational product is absorbed in the blood?
- Are there side effects?
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide informed consent
- •In generally good health
- •BMI 18 to 38kg/m²
- •Scheduled to undergo wisdom teeth extraction
排除标准
- •Serious medical condition
- •Clinically significant abnormal lab values
- •Blood donation in the last 60 days, or plasma donation in the last 7 days.
研究组 & 干预措施
ARC-001
0.75 mL gel emulsion with active ingredient applied once to the surgical site.
干预措施: ARC-001 (Drug)
Placebo
0.75 mL gel without active ingredient applied once to the surgical site.
干预措施: Placebo gel (Drug)
结局指标
主要结局
Safety and Tolerability
时间窗: 28 Days
To evaluate the safety and tolerability of ARC-001 Gel compared to placebo by comparing the incidence of oral treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through oral exam for soft tissue health using the modified Landry Index and evaluation of the presence or absence of dry socket.
次要结局
未报告次要终点