A Phase 1 Study to Evaluate the Safety and Efficacy of Sequential Administration of AGN-151586 and BOTOX® in Subjects for Treatment of Glabellar Lines (GL)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 9
- 主要终点
- Number of Participants with Adverse Events (AEs)
研究概览
简要总结
Facial lines that develop from repeated facial expression, such as glabellar lines (GL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. The purpose of this study is to assess how safe and effective sequential administration of AGN-151586 and OnabotulinumtoxinA (BOTOX) is in adult participants with moderate to severe GL.
AGN-151586 is an investigational drug being developed for treatment of moderate to severe glabellar lines. Participants are placed into 1 of 2 groups called treatment arms. In both arms participants will receive both AGN-151586 and BOTOX. Approximately 120 adult participants with moderate to severe glabellar lines enrolled in the study in approximately 8 sites around the United States.
Participants will receive injections of AGN-151586 on Day 1 in the glabellar complex. After meeting treatment criteria, participants in Cohort 1 will receive intramuscular injections of BOTOX on Day 14, and participants in Cohort 2 will receive intramuscular injections of BOTOX on Day 21. Participants will be followed for up to approximately 141 days.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate or severe glabellar lines (GL) at maximum frown as assessed by both the investigator and participant using the Facial Wrinkle Scale (FWS) at Screening and Baseline (Day 1) Visits
- •Must be in good health as per investigator's judgment based on medical history, physical examination, vital sign measurements, and 12-lead ECG parameters
- •Must have sufficient visual acuity without the use of eyeglasses (contact lens use is acceptable) to accurately assess their GL, in the opinion of the investigator.
排除标准
- •Severe glabellar lines at rest as assessed by the investigator using the FWS
- •Prior exposure to botulinum neurotoxin of any serotype within the last 12 months prior to screening
- •History of hypersensitivity to any botulinum neurotoxin serotype or any other constituents of the study drug
研究组 & 干预措施
Cohort 2 - AGN-151586 and BOTOX
Participants will receive AGN-151586 on Day 1, followed by BOTOX on Day 21.
干预措施: AGN-151586 (Drug)
Cohort 2 - AGN-151586 and BOTOX
Participants will receive AGN-151586 on Day 1, followed by BOTOX on Day 21.
干预措施: BOTOX (Drug)
Cohort 1 - AGN-151586 and BOTOX
Participants will receive AGN-151586 on Day 1, followed by BOTOX on Day 14.
干预措施: AGN-151586 (Drug)
Cohort 1 - AGN-151586 and BOTOX
Participants will receive AGN-151586 on Day 1, followed by BOTOX on Day 14.
干预措施: BOTOX (Drug)
结局指标
主要结局
Number of Participants with Adverse Events (AEs)
时间窗: Up to Approximately Day 141
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug and the study drug injection procedure.
次要结局
未报告次要终点