ACTRN12618000868280已完成1 期
A Phase 1 Study to Evaluate the Safety and Tolerability of CBL-514 Injection on Convexity or Fullness of Abdominal Subcutaneous Fat in Healthy Volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 64 Years（—）
- 性别
- All
入选标准
- •A subject can participate in the study only if all the following criteria are met:
- •1. Aged 18 years to 64 years old (at Screening), inclusive.
- •2. Body Mass Index >18.5 and <35 kg/m^2 and body weight greater than or equal to 50 kg at Screening and Day 1.
- •3. Has maximum waist circumference greater than or equal to 80 cm
- •4. Subcutaneous fat thickness of at least 3.0 cm by pinch method (measured by calibrated caliper) surrounding the navel at Screening and Day 1.
- •5. Voluntarily signs the informed consent form and, in the opinion of the investigators or delegates, are physically and mentally capable of participating in the study and willing to adhere to study procedures
排除标准
- •A subject who meets any of the following criteria will not be eligible to enter the study:
- •1. Female subject of childbearing potential who is not willing to commit to an acceptable contraceptive regimen with her partner from the time of Screening and throughout study participation until 12 weeks after the last study drug dose, or who is currently pregnant or lactating. Male subject who is not willing to commit to an acceptable contraceptive method.
- •Females who have been surgically sterilized (hysterectomy or bilateral oophorectomy) or who are postmenopausal (e.g., defined as at least 50 years with greater than or equal to 12 months of amenorrhea with a follicle stimulating hormone >40 IU/L) are considered to be of non-childbearing potential. Subjects who are not of childbearing potential are not required to use contraception.
- •2. Subject diagnosed with coagulation disorders or is receiving anticoagulant/antiplatelet therapy or medications or dietary supplements, which impede coagulation or platelet aggregation.
- •3. Subject has diabetes or glycated hemoglobin greater than or equal to 6.5% (48 mmol/mol) or fasting blood sugar greater than or equal to 7 mmol/L.
- •4. Subject has a cardiovascular disease, or shows clinically significant abnormal findings in ECG at Screening.
- •5. Subject with active or prior history of malignancies (except for successfully treated non invasive basal cell carcinoma) or being worked-up for a possible malignancy.
- •6. Subject with a history of human immunodeficiency virus (HIV)-1, hepatitis B, or hepatitis C infections or subjects with active HIV, hepatitis B, or hepatitis C infections at Screening:
- •a. Active HIV infection: positive HIV Ag/Ab combo test;
- •b. Active hepatitis B virus (HBV) infection: positive HBV surface antigen (HBsAg). Subjects with negative HBsAg but with positive HBV core antibody with or without positive HBV surface antibody will also be excluded. However, subjects with negative HBsAg, negative HBV core antibody, and positive HBV surface antibody may be included.
- •c. Active hepatitis C virus (HCV) infection: positive HCV antibody.
- •7. Subject has abnormal skin or local skin conditions, which in the opinion of Investigator is inappropriate to participate in the study, including but not limited to any of the following:
- •a. Skin manifestations of a systemic disease,
- •b. Any abnormality of the skin or soft tissues of the abdominal wall in the area to be treated,
- •c. Skin or superficial tissue that does not lie flat on its own when the subject is in the supine position,
- •d. Sensory loss or dysesthesia in the area to be treated,
- •e. Evidence of any cause of enlargement in the abdominal area other than localized subcutaneous fat,
- •f. Tattoos on the area to be treated.
- •8. Subject who has undergone the following procedures:
- •a. Previous open or laparoscopic abdominal surgery in the anticipated treatment area,
- •b. Cardiac pacemakers or any implantable electrical device,
- •c. Metal implants of any type in the area to be treated,
- •d. Esthetic procedure to the region to be treated within 6 months before Screening.
- •9. Subject is on prescription or over-the-counter weight reduction medication or weight reduction programs within 3 months before Screening.
- •10. Subject is undergoing chronic steroid or immunosuppressive therapy.
- •11. Requiring continual use of the following therapeutic agents during the study: S-mephenytoin, terfenadine, buspirone, fexofenadine, breast cancer resistan
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