A Two-Part Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Subcutaneous Doses of TCMCB07 on Healthy Male and Female Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Endevica Bio
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Number of people with an Adverse Event Assessment
研究概览
简要总结
This study will test an experimental drug named TCMCB07 for the treatment of cancer cachexia. Cachexia is a syndrome characterized by weight loss, anorexia, weakness or lack of energy, and anemia. Cachexia occurs in many cancers, usually at the advanced stages of disease.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females (WONCBP), aged 18 to 55 years inclusive, at time of signing informed consent.
- •Body mass index 18.0 to 30.0 kg/m2 as measured at Screening or, if outside this range, considered not clinically significant by the investigator.
- •Weight ≥ 50 kg at Screening
排除标准
- •Serious adverse reaction or serious known hypersensitivity to melanocortins or polyethylene glycol.
- •Evidence of current severe acute respiratory syndrome coronavirus 2 infection.
- •Clinically significant abnormal clinical chemistry, hematology, or urinalysis as judged by the investigator.
- •Subjects who have received any IP in a clinical research study within 5 half-lives or within 30 days prior to first dose. However, in no event shall the time between last receipt of IP and first dose be less than 30 days.
研究组 & 干预措施
TCMCB07
once daily subcutaneous injection
干预措施: TCMCB07 (Drug)
Placebo
once daily subcutaneous injection
干预措施: Placebo (Drug)
结局指标
主要结局
Number of people with an Adverse Event Assessment
时间窗: 6 Months
Adverse Event monitoring
Number of people with abnormal physical examinations
时间窗: 6 Months
Physical and injection site examination
Number of participants with abnormal vital signs
时间窗: 6 Months
Assessment of vital signs
Number of people with abnormal Electrocardiograms
时间窗: 6 Months
12-lead ECGs will be used and an assessment of any clinically significant abnormality from baseline will be reported as an AE
Number of people with abnormal laboratory test results
时间窗: 6 Months
Analysis of clinical chemistry, hematology, and urinalysis
次要结局
- Area under the plasma concentration versus time curve (AUC)(6 months)
- Peak Plasma Concentration (Cmax)(6 Months)