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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04575467




Registration number
NCT04575467
Ethics application status
Date submitted
19/08/2020
Date registered
5/10/2020
Date last updated
7/01/2021

Titles & IDs
Public title
A Study to Evaluate the Efficacy, Safety, and Tolerability of CBL-514 Injection for Reducing Thigh Subcutaneous Fat (Stage 1)
Scientific title
A 2-Stage Adaptive Design, Phase 2 Study to Evaluate the Efficacy, Safety and Tolerability of CBL-514 Injection for Reducing Thigh Subcutaneous Fat (Stage 1)
Secondary ID [1] 0 0
CBL-0202
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Subcutaneous Fat 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CBL-514

Experimental: CBL-514 320 mg -

Experimental: CBL-514 480 mg -

Experimental: CBL-514 640 mg -

Experimental: CBL-514 800 mg -


Treatment: Drugs: CBL-514
CBL-514 will be administered via injection into the thigh subcutaneous adipose layer.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of treatment emergent adverse events (TEAEs) - Number of participants experiencing TEAEs and number of individual TEAEs among treatment groups by severity and relationship to investigational product (IP)
Timepoint [1] 0 0
Up to 4 weeks after treatment
Primary outcome [2] 0 0
Number of participants with clinically significant abnormalities in clinical laboratory values - Clinical laboratory tests include Biochemistry, Hematology, Coagulation and Urinalysis test
Timepoint [2] 0 0
Up to 4 weeks after treatment
Primary outcome [3] 0 0
Number of participants with clinically significant abnormalities in vital signs - Vital signs measurements include temperature, pulse rate, blood pressure, and respiratory rate
Timepoint [3] 0 0
Up to 4 weeks after treatment
Primary outcome [4] 0 0
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
Timepoint [4] 0 0
Up to 4 weeks after treatment
Primary outcome [5] 0 0
Number of participants with clinically significant abnormalities in physical examination - Physical examinations include assessment of cardiovascular, respiratory, gastrointestinal, and neurological systems
Timepoint [5] 0 0
Up to 4 weeks after treatment
Primary outcome [6] 0 0
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
Timepoint [6] 0 0
Up to 4 weeks after treatment
Secondary outcome [1] 0 0
Change in thigh subcutaneous fat thickness as measured by ultrasound compared to Baseline
Timepoint [1] 0 0
Up to 4 weeks after treatment
Secondary outcome [2] 0 0
Change in thigh subcutaneous fat volume over the treated area as measured by ultrasound compared to Baseline
Timepoint [2] 0 0
Up to 4 weeks after treatment

Eligibility
Key inclusion criteria
1. Body mass index (BMI) >18.5 and <32 kg/m2 and body weight =50 kg at Screening and Day
1.

2. Subject has sufficient thigh subcutaneous fat thickness of at least 1.50 cm (15.0 mm)
and up to 5.00 cm (50.0 mm) measured by ultrasound, surrounding the center of
treatment area at Screening and Day 1.

3. Subject has stable body weight (identified as = 5% weight change) for at least 3
months before Screening and during the study.

4. 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.

5. 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
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 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.

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) = 9%, delayed would healing, or any
diabetic risks which, in the opinion of Investigator, is inappropriate to participate
in the study.

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:

1. Skin manifestations of a systemic disease,

2. Any abnormality of the skin or soft tissues of the area to be treated,

3. Grade III cellulite (Nürnberger and Muller scale, Nürnberger F, 1978) at the area
to be treated,

4. Skin folding on treatment area when the subject is in the supine position,

5. Sensory loss or dysesthesia in the area to be treated,

6. Evidence of any cause of enlargement in the area to be treated other than
localized subcutaneous fat,

7. Tattoos on the area to be treated.

9. Subject who has undergone the following procedures:

1. Previous surgery in the anticipated treatment area,

2. Cardiac pacemakers or any implantable electrical device,

3. Metal implants of any type in the area to be treated,

4. Esthetic procedure i.e. liposuction to the region to be treated,

5. Esthetic procedure e.g. cryolipolysis, ultrasonic lipolysis, low level laser
therapy (LLLT), lipolysis injection to the region to be treated within 12 months
before Screening or during the study.

10. 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.

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 × 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 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
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
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
Recruitment hospital [1] 0 0
Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Caliway Biopharmaceuticals Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/show/NCT04575467
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Anne Sheu
Address 0 0
Country 0 0
Phone 0 0
+886-2-26971355
Fax 0 0
Email 0 0
CR@caliway.com.tw
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04575467