NCT05162326尚未招募1 期
A Phase 1/2 Study of the Safety and Efficacy of BC-101 in Treatment of Nasolabial Fold Wrinkles Via Subcutaneous/Intradermal Injection
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 9
- 主要终点
- Incidence of any treatment-emergent adverse events
研究概览
简要总结
This is an open-label, single-arm, dose-escalating study to evaluate the safety and tolerability of BC-101 administered via subcutaneous/intradermal injection in the treatment of moderate to severe nasolabial folds.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who are in general good health condition.
- •Subjects who have moderate to extremely deep bilateral nasolabial fold wrinkles, as documented by a score of 3 or greater on the six-point Evaluator Wrinkle Severity Assessment scale (0-5).
- •Subjects who are dissatisfied with both nasolabial fold wrinkles based on a score of -1 or -2 on the Subject Wrinkle Assessment Scale (-2 to +2).
- •Subjects who voluntarily adhere to the research procedures and ensure good compliance during the research period.
- •Subjects who fully understand the research nature of this study and sign the informed consent.
排除标准
- •Subjects who have an active cutaneous infection on the face.
- •Subjects with existing malignant neoplasm.
- •Subjects with persistent pre-cancerous lesions (e.g., actinic keratosis).
- •Subjects who have active dermal diseases, inflammation, or any related disease.
- •Subjects who have cosmetic or surgical treatment on nasolabial fold area in 3 months before the study (including laser, chemical peels, fillers, botulinum toxin).
- •Subjects who are pregnant, breastfeeding, or whose urinary pregnancy test is positive before participation in the study.
- •Subjects who are allergic to low-molecular-weight heparin sodium or human albumin.
研究组 & 干预措施
BC-101
Experimental
BC-101 will be injected at the dose of 0.1 mL per linear centimeter along the nasolabial fold, up to 2 mL in total volume for each side of the nasolabial folds.
干预措施: BC-101 (Biological)
结局指标
主要结局
Incidence of any treatment-emergent adverse events
时间窗: 12 weeks after injection
次要结局
- Changes in wrinkle severity assessment from baseline(6 weeks, 12 weeks and 26 weeks after injection)
研究者
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