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Trial registered on ANZCTR


Registration number
ACTRN12619001580167
Ethics application status
Approved
Date submitted
29/10/2019
Date registered
18/11/2019
Date last updated
1/12/2020
Date data sharing statement initially provided
18/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
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
Scientific title
A Phase 2a Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of CBL-514 Injection on Convexity or Fullness of Abdominal Subcutaneous Fat in Healthy Volunteers
Secondary ID [1] 299321 0
CBL-16001
Universal Trial Number (UTN)
Trial acronym
Linked study record
ACTRN12618000868280 is the phase 1 part of the CBL-16001 study.

Health condition
Health condition(s) or problem(s) studied:
Healthy subjects with undesirable subcutaneous fat thickness in belly 314458 0
Condition category
Condition code
Skin 312793 312793 0 0
Dermatological conditions
Diet and Nutrition 312794 312794 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
CBL-514 will be administered via injection into the abdominal subcutaneous adipose layer. Eligible subjects will be randomized to 1 of 3 treatment groups: 180, 240, and 300 mg of CBL-514-active pharmaceutical ingredient. Subjects will receive 4 treatments of CBL-514 which will be given once every 2 weeks, over a period of 6 weeks. A total of 60 injections of CBL-514 will be evenly administered by 1.58 cm apart at the treatment area and the amount of each injection is 0.6, 0.8, and 1.0 ml based on the design of dose groups.
Intervention code [1] 315588 0
Treatment: Drugs
Comparator / control treatment
Three dose groups will be conducted: 180, 240 and 300 mg CBL-514. This study will evaluate the difference between these groups.
Control group
Dose comparison

Outcomes
Primary outcome [1] 321417 0
Change from baseline in Waist circumference (WC) by measuring tape
Timepoint [1] 321417 0
On Day 1, biweekly until the follow-up visits on Week 10 and Week 14
Secondary outcome [1] 374914 0
Change from baseline in abdominal subcutaneous fat thickness measured by ultrasound
Timepoint [1] 374914 0
On Day 1, Week 10 and Week 14
Secondary outcome [2] 375274 0
Safety as assessed by recording of TEAEs, laboratory assessments, vital signs, ECGs, physical examinations, and injection site reactions.
Timepoint [2] 375274 0
On Day 1, biweekly until the follow-up visits on Week 10 and Week 14
Secondary outcome [3] 389431 0
Change from baseline in abdominal subcutaneous fat volume by calculation derived from fat thickness measured by ultrasound..
Timepoint [3] 389431 0
On Day 1, week 10 and Week 14

Eligibility
Key inclusion criteria
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.
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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 months of 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 until 24 hours post-dose or the collection of the last PK sample, whichever is later.

13. Unable to receive topical anesthesia (e.g., history of hypersensitivity to lidocaine).

14. Subjects with known allergies or sensitivities to the study drug and/or excipients.

15. Subjects with inadequate liver function at Screening defined as aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), total bilirubin, or gamma-glutamyl transferase (GGT) >3.0 × upper limit of normal (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 m^2. 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
Randomised controlled 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
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2019
Actual
3/02/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
66
Accrual to date
23
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14882 0
Dermatology Institute of Victoria - South Yarra
Recruitment postcode(s) [1] 28149 0
3141 - South Yarra

Funding & Sponsors
Funding source category [1] 303838 0
Commercial sector/Industry
Name [1] 303838 0
Caliway Biopharmaceuticals Australia Pty Ltd
Country [1] 303838 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] 304083 0
None
Name [1] 304083 0
None
Address [1] 304083 0
None
Country [1] 304083 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304353 0
Bellberry Limited
Ethics committee address [1] 304353 0
Ethics committee country [1] 304353 0
Australia
Date submitted for ethics approval [1] 304353 0
23/10/2019
Approval date [1] 304353 0
08/11/2019
Ethics approval number [1] 304353 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96654 0
Dr Greg Goodman
Address 96654 0
Dermatology Institute of Victoria
8–10 Howitt Street
South Yarra Vic 3141
Country 96654 0
Australia
Phone 96654 0
+61 3 98264966
Fax 96654 0
Email 96654 0
gg@div.net.au
Contact person for public queries
Name 96655 0
Shih-Chun Lu
Address 96655 0
Caliway Biopharmaceuticals Australia Pty Ltd
58 Gipps Street, Collingwood, 3066 Vic, Australia
Country 96655 0
Australia
Phone 96655 0
+61 3 9419 7607
Fax 96655 0
Email 96655 0
jessica.lu@caliway.com.tw
Contact person for scientific queries
Name 96656 0
Ying-Jie Chen
Address 96656 0
Caliway Biopharmaceuticals Australia Pty Ltd
58 Gipps Street, Collingwood, 3066 Vic, Australia
Country 96656 0
Australia
Phone 96656 0
+61 3 9419 7607
Fax 96656 0
Email 96656 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 Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.