ACTRN12619001580167招募中2 期
A Phase 2a Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of CBL-514 Injection on Convexity or Fullness of Abdominal Subcutaneous Fat in Healthy Volunteers
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 66
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
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 64 Years（—）
- 性别
- All
入选标准
- •1. Male/female aged 18 years to 64 years old (at Screening), inclusive.
- •2. Body mass index (BMI) > 18.5 and < 35 kg/m^2, and body weight greater than or equal to 50 kg at Screening and Day 1.
- •3. Has waist circumference between 80.0 cm and 110.0 cm at Screening and Day 1.
- •4. Subcutaneous fat thickness of at least 3.00 cm and up to 6.00 cm by pinch method (measured by calibrated caliper) surrounding the center of treatment area at Screening and Day 1.
- •5. Subject has stable body weight (change of body weight <5%) for at least 3 months before Screening and during the study.
- •6. Subject who has maintained a stable lifestyle (e.g. exercise, eating patterns, and smoking habit) for at least 3 months before Screening and during the study.
- •7. Voluntarily signs the Informed Consent Form and, in the opinion of the Investigator or delegate, is physically and mentally capable of participating 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 equal to or longer than 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 (HbA1c) equal to or greater than 6.5% (48 mmol/mol) or fasting blood sugar (FBS) equal to or greater than 7 mmol/L.
- •4. Subject has a clinically significant cardiovascular disease and abnormal findings in ECG.
- •5. Subject with active or prior history of malignancies or being worked-up for a possible malignancy within 5 years before Screening.
- •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): positive HCV antibody.
- •7. Subject has abnormal skin or local skin conditions at the treatment area, 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 hernia.
- •9. 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 i.e. liposuction to the region to be treated within 12 months before Screening or during the study,
- •e. Esthetic procedure i.e. cryolipolysis, ultrasonic lipolysis, low level laser therapy, lipolysis injection to the region to be treated within 6 months before Screening or during the study.
- •10. Subject is on prescription or over-the-counter weight reduction medication or weight reduction programs within 3
研究者
相似试验
已完成
1 期
A Phase 1/2a Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamic Effects and Exploratory Efficacy of FPP003 Vaccine in Subjects with Psoriasis.PsoriasisSkin - Dermatological conditionsACTRN12619000599178FunPep Co. Ltd.36
进行中（未招募）
不适用
A Phase II Study to Assess the Safety, Tolerability, and Efficacy of MK-0822 (Cathepsin-K Inhibitor) in the Treatment of Women with Breast Cancer and Established Bone Metastases (MBD) - Women with Breast Cancer and Established Metastatic Bone DiseaseMetastaic Bone Disease (MBD)MedDRA version: 8.1Level: LLTClassification code 10027452Term: Metastases to boneEUCTR2006-002669-38-DKMerck & Co., Inc.
进行中（未招募）
不适用
A Phase II Study to Assess the Safety, Tolerability, and Efficacy of MK-0822 (Cathepsin-K Inhibitor) in the Treatment of Women with Breast Cancer and Established Bone Metastases (MBD) - Women with Breast Cancer and Established Metastatic Bone DiseaseMetastatic Bone Disease (MBD)MedDRA version: 8.1Level: LLTClassification code 10027452Term: Metastases to boneEUCTR2006-002669-38-DEMerck & Co Inc.45
进行中（未招募）
1 期
A Phase II Study to Assess the Safety, Tolerability, and Efficacy of MK-0822 (Cathepsin-K Inhibitor) in the Treatment of Women with Breast Cancer and Established Bone Metastases (MBD) - Women with Breast Cancer and Established Metastatic Bone DiseaseMetastaic Bone Disease (MBD)MedDRA version: 8.1 Level: LLT Classification code 10027452 Term: Metastases to boneEUCTR2006-002669-38-NOMSD (Norge) AS56
招募中
1 期
A Phase 2 Study to Evaluate the Safety, Tolerability, and Efficacy of Regimens Containing VIR -2218, VIR-3434, and/or PEG-IFNa in Subjects with Chronic Hepatitis B Virus InfectioEUCTR2021-001033-39-DEVir Biotechnology, Inc.260