A Phase 2 Study to Evaluate the Efficacy, Safety and Tolerability of CBL 514 Injection on Thigh Subcutaneous Fat
- Conditions
- Healthy to overweight subjects with undesirable subcutaneous fat thickness in thighsSkin - Dermatological conditionsDiet and Nutrition - Obesity
- Registration Number
- ACTRN12620001153909
- Lead Sponsor
- Caliway Biopharmaceuticals Australia Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 18
To be eligible for this study, a subject must meet all of the following inclusion criteria:
1.Male or female, aged 18 years to 64 years old (at Screening), inclusive.
2.Body mass index (BMI) >18.5 and <32 kg/m2 and body weight great than or equal to 50 kg at Screening and Day 1.
3.Subject has sufficient thigh subcutaneous fat thickness of at least 1.50 cm and up to 5.00 cm measured by ultrasound, surrounding the center of treatment area at Screening and Day 1.
4.Subject has stable body weight (identified as smaller than or equal to 5% weight change) for at least 3 months before Screening and during the study.
5.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.
6.Voluntarily signs the Informed Consent Form (ICF) and, in the opinion of the Investigator or delegate, is physically and mentally capable of participating in the study, and willing to adhere to study procedures.
A subject who meets any of the following exclusion criteria must be excluded from 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 90 days after the last IP 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 post-menopausal (e.g., defined as at least 50 years with greater than or equal to 12 months of amenorrhea with a FSH >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 fasting hemoglobin A1c (HbA1c) great than or equal to 7%.
4.Subject has a clinically significant cardiovascular disease and abnormal findings in electrocardiogram (ECG).
5.Subject with active or prior history of malignancies within 5 years before Screening or being worked-up for a possible malignancy. Except adequately treated basal cell carcinoma of skin and in situ squamous cell carcinoma of skin would be eligible as per Investigator’s discretion.
6.Subject with a history of human immunodeficiency virus (HIV)-1, infection or subjects with active HIV infection at Screening with positive HIV antigen/antibody (Ag/Ab) combo test.
7.Subjects with any hepatic medical condition that would interfere with assessment of safety or efficacy or compromise the subject's ability to undergo study procedures or provide informed consent.
8.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 area to be treated,
c.Grade III cellulite (Nürnberger and Muller scale, Nürnberger F, 1978) at the area to be treated,
d.Skin or superficial tissue that does not lie flat on its own when the subject is in the supine position,
e.Sensory loss or dysesthesia in the area to be treated,
f.Evidence of any cause of enlargement in the area to be treated other than localized subcutaneous fat,
g.Tattoos on the area to be treated.
9.Subject who has undergone the following procedures:
a.Previous surgery in the anticipated treatment area,
b.Metal implants of any type in the area to be treated,
c.Esthetic procedure i.e. liposuction to the region to be treated within 12 months before Screening or during the study,
d.Esthetic procedure e.g. cryolipolysis, ultrasonic lipolysis, low level laser therapy (LLLT), lipolysis injection to the region to be treated within 6 months before Screening or during the study.
10.Subject is on prescription or OTC weight reduction medication or weight reduction programs within 3 months before Screening or during the study.
11.Subject is undergoing chronic steroid or immunosuppressive therapy.
12.Requiring continual use of the following therapeutic agents during the study: S mephenytoin (Mesantoin), terfenadine (Teldane), buspirone (Buspar), fexofenadine (Fexotabs, Tef
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and tolerability following single dose of CBL-514 as assessed by recording of treatment emergent adverse events (TEAEs), laboratory assessments, vital signs, ECGs, physical examinations, and injection site assessment.<br><br>Treatment-emergent adverse events will be summarized by system organ class, preferred term, severity, and suspected relationship to study drug.<br>The major adverse events may include localised pain, bruising, numbness, redness, swelling, edema, induration, itching, altered sensations, and skin tightness which would be around the injection sites.<br>Clinical laboratory test includes biochemistry, hematology, urinalysis, pregnancy status, and virology assessments. Physical examinations, vital signs, standard electrocardiogram and any other untoward medical events during the study period will also be recorded for assessment.<br>[On Day 1 and throughout the follow-up visits (Week 1, Week 2 and Week 4)]
- Secondary Outcome Measures
Name Time Method Change of thigh subcutaneous fat thickness as measured by ultrasound compared to Baseline[On Screening, Day 1 and Week 4 visits];Change of thigh subcutaneous fat volume over the treated area as measured by ultrasound compared to Baseline.[On Screening, Day 1 and Week 4 visits]