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The Phase 2a component of the study will be a randomized, open-label, parallel, and multiple dose study to further examine the safety and efficacy profile of 3 CBL-514 dose levels based on the results from Phase 1 of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBL-514 180 mg, 1.2 mg/cm^2 | Experimental | CBL-514 will be administrated with the grid spacing of 2.5 cm^2 |
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| CBL-514 240 mg, 1.6 mg/cm^2 | Experimental | CBL-514 will be administrated with the grid spacing of 2.5 cm^2 |
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| CBL-514 300 mg, 2 mg/cm^2 | Experimental | CBL-514 will be administrated with the grid spacing of 2.5 cm^2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBL-514 | Drug | Both sides of the abdominal region will receive CBL-514. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of abdominal subcutaneous fat volume | Change of abdominal subcutaneous fat volume as measured by ultrasound around the treated area compared to Baseline | Up to 8 weeks after last treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change of abdominal subcutaneous fat thickness | Change of abdominal subcutaneous fat thickness as measured by ultrasound-determined subcutaneous fat thickness over the treated area compared to Baseline, | Up to 8 weeks after last treatment |
| Incidence of treatment emergent adverse events (TEAEs) |
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Inclusion Criteria:
Exclusion Criteria:
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. For details on contraception, refer section 6.11.
Females who have been surgically sterilized (hysterectomy or bilateral oophorectomy) or who are postmenopausal (e.g., defined as at least 50 years with ≥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.
Subject diagnosed with coagulation disorders or is receiving anticoagulant/antiplatelet therapy or medications or dietary supplements, which impede coagulation or platelet aggregation.
Subject has diabetes or glycated hemoglobin ≥6.5% (48 mmol/mol) or fasting blood sugar ≥7 mmol/L.
Subject has a clinically significant cardiovascular disease and abnormal findings in ECG.
Subject with active or prior history of malignancies (except for successfully treated basal cell carcinoma) within 5 years before Screening or being worked-up for a possible malignancy.
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:
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:
Subject who has hernia
Subject who has undergone the following procedures:
Subject is on prescription or over-the-counter weight reduction medication or weight reduction programs within 3 months before Screening or during the study.
Subject is undergoing chronic steroid or immunosuppressive therapy.
Requiring continual use of the following therapeutic agents during the study:1 S-mephenytoin (Mesantoin), terfenadine (Teldane), buspirone (Buspar), fexofenadine (Fexotabs, Tefodine, Telfast, Xergic, Allegra).
If a subject needs to use the above mentioned therapeutic agents during the study for any reason, these therapeutic agents should not be used at least for 2 days prior to dosing until 1 day post-dose, whichever is later.
Unable to receive topical anesthesia (e.g., history of hypersensitivity to lidocaine).
Subjects with known allergies or sensitivities to the study drug and/or excipients
Subjects with inadequate liver function at Screening defined as aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, total bilirubin, or gamma-glutamyl transferase >3.0 × ULN.
Subjects with inadequate renal function, defined as abnormal serum creatinine, and urea >1.5 × ULN or estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2. Subjects who are currently on dialysis should be excluded.
Use of other investigational drug or device within 4 weeks prior to Screening.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational site | Melbourne | Australia |
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Number of participants experiencing TEAEs and number of individual TEAEs among treatment groups by severity and relationship to investigational product (IP) |
| Up to 8 weeks after last treatment |
| Number of participants with clinically significant abnormalities in clinical laboratory values | Clinical laboratory tests include Biochemistry, Hematology, Coagulation and Urinalysis test | Up to 4 weeks after last treatment |
| Number of participants with clinically significant abnormalities in vital signs | Vital signs measurements include temperature, pulse rate, blood pressure, and respiratory rate | Up to 8 weeks after last treatment |
| Number of participants with clinically significant abnormalities in Electrocardiogram (ECG) | ECG parameters include heart rate, RR interval, PR interval, QT interval, QTc interval, and QRS interval | Up to 4 weeks after last treatment |
| Number of participants with clinically significant abnormalities in physical examination | Physical examinations include assessment of cardiovascular, respiratory, gastrointestinal, and neurological systems | Up to 8 weeks after last treatment |
| Number of participants with injection site reactions | Injection site reactions include but not limited to redness, swelling, bruising, tenderness, itching, pain, warmth, discoloration and hardness | Up to 8 weeks after last treatment |