A Phase 2a Study to Evaluate the Preliminary Efficacy and Safety of CBL-514 Injection on Convexity or Fullness of Abdominal Subcutaneous Fat in Healthy Volunteers
- Conditions
- Healthy subjects with undesirable subcutaneous fat thickness in bellySkin - Dermatological conditionsDiet and Nutrition - Obesity
- Registration Number
- ACTRN12619001580167
- Lead Sponsor
- Caliway Biopharmaceuticals Australia Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 66
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in Waist circumference (WC) by measuring tape [On Day 1, biweekly until the follow-up visits on Week 10 and Week 14]
- Secondary Outcome Measures
Name Time Method Change from baseline in abdominal subcutaneous fat thickness measured by ultrasound [On Day 1, Week 10 and Week 14];Safety as assessed by recording of TEAEs, laboratory assessments, vital signs, ECGs, physical examinations, and injection site reactions.[On Day 1, biweekly until the follow-up visits on Week 10 and Week 14];Change from baseline in abdominal subcutaneous fat volume by calculation derived from fat thickness measured by ultrasound..[On Day 1, week 10 and Week 14]