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Trial registered on ANZCTR


Registration number
ACTRN12620001153909p
Ethics application status
Submitted, not yet approved
Date submitted
7/08/2020
Date registered
3/11/2020
Date last updated
3/11/2020
Date data sharing statement initially provided
3/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 2 Study to Evaluate the Efficacy, Safety and Tolerability of CBL 514 Injection on Thigh Subcutaneous Fat
Scientific title
A Phase 2 Study to Evaluate the Efficacy, Safety and Tolerability of CBL 514 Injectionon Thigh Subcutaneous Fat in healthy adults
Secondary ID [1] 301967 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy to overweight subjects with undesirable subcutaneous fat thickness in thighs 318542 0
Condition category
Condition code
Skin 316549 316549 0 0
Dermatological conditions
Diet and Nutrition 316550 316550 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
CBL-514 will be administered via injection into the subcutaneous adipose layer on thigh. The intervention will be administered in a single dose escalation scheme with 4 sequential groups. The eligibility of the subjects in each sequential group are the same.
The design of dose escalation is 320, 480, 640 and 800 mg of CBL-514-active pharmaceutical ingredient which will be administered with 40, 60, 80, 100 injections respectively. The amount of CBL-514 per injection is 1.6 mL in all four groups. One dose of CBL-514 will be divided into two and evenly administered on both thighs. The dosing between groups will be separated by at least 7 days. Subject diary would be provided after dosing for subject to record their conditions.
Intervention code [1] 318267 0
Treatment: Drugs
Comparator / control treatment
Four dose groups will be conducted: 320, 480, 640 ,800 mg CBL-514.


Control group
Dose comparison

Outcomes
Primary outcome [1] 324677 0
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.

Treatment-emergent adverse events will be summarized by system organ class, preferred term, severity, and suspected relationship to study drug.
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.
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.
Timepoint [1] 324677 0
On Day 1 and throughout the follow-up visits (Week 1, Week 2 and Week 4)
Secondary outcome [1] 385385 0
Change of thigh subcutaneous fat thickness as measured by ultrasound compared to Baseline
Timepoint [1] 385385 0
On Screening, Day 1 and Week 4 visits
Secondary outcome [2] 385386 0
Change of thigh subcutaneous fat volume over the treated area as measured by ultrasound compared to Baseline.
Timepoint [2] 385386 0
On Screening, Day 1 and Week 4 visits

Eligibility
Key inclusion criteria
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.
Minimum age
18 Years
Maximum age
64 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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, 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.
13. Unable to receive topical anesthesia (e.g., history of hypersensitivity to Benzocaine, lidocaine, or Tetracaine).
14. Subjects with known allergies or sensitivities to the IP or its components.
15. 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 × ULN.
16. 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.
17. Use of other investigational drug or device within 4 weeks prior to Screening.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Single dose, open label, dose escalation
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 306390 0
Commercial sector/Industry
Name [1] 306390 0
Caliway Biopharmaceuticals Australia Pty Ltd
Address [1] 306390 0
58 Gipps Street, Collingwood, 3066 Vic, Australia
Country [1] 306390 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Caliway Biopharmaceuticals Australia Pty Ltd
Address
58 Gipps Street, Collingwood, 3066 Vic, Australia
Country
Australia
Secondary sponsor category [1] 306893 0
None
Name [1] 306893 0
None
Address [1] 306893 0
None
Country [1] 306893 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 306589 0
Bellberry Limited
Ethics committee address [1] 306589 0
123 Glen Osmond Road Eastwood SA 5063
Ethics committee country [1] 306589 0
Australia
Date submitted for ethics approval [1] 306589 0
19/08/2020
Approval date [1] 306589 0
Ethics approval number [1] 306589 0

Summary
Brief summary
This is a Phase 2 trial to be conducted in a single center in Australia to evaluate the safety and tolerability of CBL-514 Injection on subcutaneous fat of both thighs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104386 0
Dr Greg Goodman
Address 104386 0
Dermatology Institute of Victoria
8–10 Howitt Street South Yarra Vic 3141
Country 104386 0
Australia
Phone 104386 0
+61 3 98264966
Fax 104386 0
Email 104386 0
gg@div.net.au
Contact person for public queries
Name 104387 0
Ms Liang-Chieh Huang
Address 104387 0
Caliway Biopharmaceuticals Australia Pty Ltd
58 Gipps Street, Collingwood, 3066 Vic, Australia
Country 104387 0
Australia
Phone 104387 0
+61 3 9419 7607
Fax 104387 0
Email 104387 0
cr@caliway.com.tw
Contact person for scientific queries
Name 104388 0
Dr Ying-Jie Chen
Address 104388 0
Caliway Biopharmaceuticals Australia Pty Ltd
58 Gipps Street, Collingwood, 3066 Vic, Australia
Country 104388 0
Australia
Phone 104388 0
+61 3 9419 7607
Fax 104388 0
Email 104388 0
ying-jie.chen@caliway.com.tw

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Due to the commercial consideration and protection of privacy, the individual participant data for this trial will not be available.
What supporting documents are/will be available?
No other documents available
Summary results
No Results