A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CBP-4888 in Healthy, Non-Pregnant Female Subjects
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Tenderness at Site of Injection
研究概览
简要总结
This is a Phase I, first-in-human, single-center, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, and PK of ascending doses of CBP-4888.
详细描述
This study will involve female subjects meeting all inclusion criteria and no exclusion criteria. Cohorts of CBP-4888 are planned to be investigated in a sequential dose-escalation manner. Each cohort of subjects will be randomized to CBP-4888 to placebo and administered a single subcutaneous dose.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy non-pregnant female subjects
- •Body mass index (BMI) ≥ 18.5 and ≤ 35.0 kg/m2
- •Medically healthy, defined as having no clinically significant abnormal screening results including clinical laboratory evaluations, medical history, vital signs, ECG, and physical examination as deemed by the Investigator.
排除标准
- •Screening blood pressure < 100/60 mmHg or > 140/90 mmHg
- •Screening heart rate that is < 40 bpm or > 99 bpm
- •Clinically significant ECG abnormality at screening
- •Used prescription medication within 14 days prior to dosing
- •Used over the counter (OTC) medications (including herbal products, nutritional supplements, dietary supplements, and/or vitamins) within 7 days prior to dosing
- •Donated blood or had significant blood loss within 56 days prior to dosing
研究组 & 干预措施
CBP-4888
CBP-4888 administered once as a subcutaneous dose.
干预措施: CBP-4888 (Drug)
Placebo
Normal Saline administered once as a subcutaneous dose.
干预措施: Placebo (Other)
结局指标
主要结局
Tenderness at Site of Injection
时间窗: 30 Days
Assessment of Tenderness on a 5 point scale (none, mild, moderate, severe or potentially life threatening)
Swelling at Site of Injection
时间窗: 30 Days
Assessment of Swelling on a 5 point scale (none, mild, moderate, severe or potentially life threatening)
Erythema at Site of Injection
时间窗: 30 days
Assessment of Erythema on a 5 point scale (none, mild, moderate, severe or potentially life threatening)
Adverse Events
时间窗: 30 days
Number of participants with treatment-related adverse events
Pain at Site of Injection
时间窗: 30 days
Assessment of Pain on a 5 point scale (none, mild, moderate, severe or potentially life threatening)
次要结局
- Cmax of CBP-4888(30 days)
- AUC of CBP-4888(30 days)
- Tmax of CBP-4888(30 days)