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The Stage 1 of this phase 2 study is an open-label single ascending dose (SAD) study. The primary objectives are to evaluate the safety and tolerability of injection lipolysis with CBL-514. It will be followed by a parallel-arm multiple-dose design in Stage 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBL-514 320 mg | Experimental | CBL-514 will be administered via injection into the thigh subcutaneous adipose layer. |
|
| CBL-514 480 mg | Experimental | CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer. |
|
| CBL-514 640 mg | Experimental | CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer. |
|
| CBL-514 800 mg | Experimental | CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBL-514 | Drug | CBL-514 will be administered via injection into the subcutaneous adipose layer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment Emergent Adverse Events | Number of treatment emergent adverse events (TEAEs) | Up to 4 weeks after treatment |
| Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values | The clinical laboratory tests include Biochemistry, Hematology, Coagulation and Urinalysis test | Up to 4 weeks after 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 4 weeks after 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 treatment |
| Number of Participants With Clinically Significant Abnormalities in Physical Examination | Physical examinations include assessment of cardiovascular, respiratory, gastrointestinal, and neurological systems | Up to 4 weeks after 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 4 weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Subcutaneous Fat Thickness | Change in subcutaneous fat thickness as measured by ultrasound compared to Baseline. No efficacy assessments were done for Group 1 of Stage 1 study. | Up to 4 weeks after treatment |
| Change in Subcutaneous Fat Volume |
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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 90 days after the last investigational product (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 ≥12 months of amenorrhea with a follicle stimulating hormone (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.
Subject diagnosed with coagulation disorders or is receiving anticoagulant/antiplatelet therapy or medications or dietary supplements, which impede coagulation or platelet aggregation.
Subject has fasting hemoglobin A1c (HbA1c) ≥ 9%, delayed would healing, or any diabetic risks which, in the opinion of Investigator, is inappropriate to participate in the study.
Subject has a clinically significant cardiovascular disease and abnormal findings in electrocardiogram (ECG).
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.
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.
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.
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 undergone the following procedures:
Subject is on prescription or over-the-counter (OTC) 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: S mephenytoin (Mesantoin), terfenadine (Teldane), buspirone (Buspar), fexofenadine (Fexotabs, Tefodine, Telfast, Xergic, Allegra, etc.).
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 48 hours prior to dosing and until 24 hours post-dose.
Unable to receive topical anesthesia (e.g., history of hypersensitivity to Benzocaine, lidocaine, or Tetracaine).
Subjects with known allergies or sensitivities to the IP or its components.
Subjects with inadequate liver function at Screening defined as aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALKP), total bilirubin (TBIL), or gamma-glutamyl transferase (GGT) >3.0 × upper limit of normal (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 | Victoria | Australia |
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| ID | Title | Description |
|---|---|---|
| FG000 | CBL-514 320 mg | CBL-514 will be administered via injection into the thigh subcutaneous adipose layer. |
| FG001 | CBL-514 480 mg | CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer. |
| FG002 | CBL-514 640 mg | CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer |
| FG003 | CBL-514 800 mg | CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CBL-514 320 mg | CBL-514 will be administered via injection into the thigh subcutaneous adipose layer. |
| BG001 | CBL-514 480 mg | CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Treatment Emergent Adverse Events | Number of treatment emergent adverse events (TEAEs) | Safety Population | Posted | Number | number of events | Up to 4 weeks after treatment |
|
Up to 4 weeks after treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CBL-514 320 mg | CBL-514 will be administered via injection into the thigh subcutaneous adipose layer. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Closed head injury with post concussive symptoms | Injury, poisoning and procedural complications | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Candra Chou | Caliway Biopharmaceuticals Pty Ltd | 886226971355 | 1317 | candra.chou@caliway.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 1, 2023 | Jul 16, 2024 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 19, 2023 | Jul 16, 2024 | SAP_003.pdf |
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Change in subcutaneous fat volume over the treated area as measured by ultrasound compared to Baseline. No efficacy assessments were done for Group 1 of Stage 1 study. |
| Up to 4 weeks after treatment |
| BG002 | CBL-514 640 mg | CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer. |
| BG003 | CBL-514 800 mg | CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m2 |
|
| Weight | Mean | Standard Deviation | kg |
|
CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer. |
| OG003 | CBL-514 800 mg | CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer. |
|
|
| Primary | Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values | The clinical laboratory tests include Biochemistry, Hematology, Coagulation and Urinalysis test | Safety Population | Posted | Count of Participants | Participants | Up to 4 weeks after treatment |
|
|
|
| Primary | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Vital signs measurements include temperature, pulse rate, blood pressure, and respiratory rate | Safety Population | Posted | Count of Participants | Participants | Up to 4 weeks after treatment |
|
|
|
| Primary | 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 | Safety Population | Posted | Count of Participants | Participants | Up to 4 weeks after treatment |
|
|
|
| Primary | Number of Participants With Clinically Significant Abnormalities in Physical Examination | Physical examinations include assessment of cardiovascular, respiratory, gastrointestinal, and neurological systems | ITT Population | Posted | Count of Participants | Participants | Up to 4 weeks after treatment |
|
|
|
| Primary | 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 | Safety Population | Posted | Count of Participants | Participants | Up to 4 weeks after treatment |
|
|
|
| Secondary | Change in Subcutaneous Fat Thickness | Change in subcutaneous fat thickness as measured by ultrasound compared to Baseline. No efficacy assessments were done for Group 1 of Stage 1 study. | ITT Population (Data not collected for participants that received the 320 mg injection) | Posted | Mean | Standard Deviation | Absolute Change (mm) from Baseline | Up to 4 weeks after treatment |
|
|
|
|
| Secondary | Change in Subcutaneous Fat Volume | Change in subcutaneous fat volume over the treated area as measured by ultrasound compared to Baseline. No efficacy assessments were done for Group 1 of Stage 1 study. | ITT Population (Data not collected for participants that received the 320 mg injection) | Posted | Mean | Standard Deviation | Absolute change (mL) from Baseline | Up to 4 weeks after treatment |
|
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 6 |
| 6 |
| EG001 | CBL-514 480 mg | CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer. | 0 | 7 | 0 | 7 | 7 | 7 |
| EG002 | CBL-514 640 mg | CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer | 0 | 6 | 1 | 6 | 6 | 6 |
| EG003 | CBL-514 800 mg | CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer | 0 | 6 | 0 | 6 | 6 | 6 |
| Injection site bruising | General disorders | Systematic Assessment |
|
| Injection site pain | General disorders | Systematic Assessment |
|
| Injection site swelling | General disorders | Systematic Assessment |
|
| Injection site pruritus | General disorders | Systematic Assessment |
|
| Injection site warmth | General disorders | Systematic Assessment |
|
| Injection site discolouration | General disorders | Systematic Assessment |
|
| Injection site induration | General disorders | Systematic Assessment |
|
| Presyncope | Nervous system disorders | Systematic Assessment |
|
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| Mean absolute fat thickness difference |
| -4.85 |
| Standard Deviation |
| 2.02 |
| 2-Sided |
| 95 |
| -6.97 |
| -2.73 |
| Superiority |
| Paired t-test | <0.05 | Mean absolute fat thickness difference | -2.98 | Standard Deviation | 2.83 | 2-Sided | 95 | -5.95 | -0.01 | Superiority |
| Mean absolute fat volume difference |
| -155.20 |
| Standard Deviation |
| 64.70 |
| 2-Sided |
| 95 |
| -223.10 |
| -87.30 |
| Superiority |
| Paired t-test | <0.05 | Mean absolute fat volume difference | -119.17 | Standard Deviation | 113.11 | 2-Sided | 95 | -237.86 | -0.47 | Superiority |