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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04699669




Registration number
NCT04699669
Ethics application status
Date submitted
29/12/2020
Date registered
7/01/2021
Date last updated
7/01/2021

Titles & IDs
Public title
A Phase 1 Study to Evaluate the Safety and Tolerability of CBL-514 Injection on Convexity or Fullness of Abdominal Subcutaneous Fat in Healthy Volunteers
Scientific title
A 2-stage, Phase 1/2a Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of CBL-514 Injection for Reducing Convexity or Fullness of Abdominal Subcutaneous Fat (Phase 1)
Secondary ID [1] 0 0
CBL-16001(Phase 1)
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, placebo
Treatment: Drugs - CBL-514, placebo
Treatment: Drugs - CBL-514

Other: Cohort 1: CBL-514 2 mg, 0.5 mg/cm^2 - Individual placebo control. CBL-514 will be administrated with the grid spacing of 4 cm^2

Other: Cohort 2: CBL-514 10 mg, 0.5 mg/cm^2 - Individual placebo control. CBL-514 will be administrated with the grid spacing of 4 cm^2

Other: Cohort 3: CBL-514 20 mg, 0.5 mg/cm^2 - Individual placebo control. CBL-514 will be administrated with the grid spacing of 4 cm^2

Other: Cohort 4: CBL-514 40 mg, 1.0 mg/cm^2 - Individual placebo control. CBL-514 will be administrated with the grid spacing of 4 cm^2

Other: Cohort 5: CBL-514 40 mg, 2 mg/cm^2 - Individual placebo control. CBL-514 will be administrated with the grid spacing of 2 cm^2

Experimental: Cohort 6: CBL-514 80 mg, 2 mg/cm^2 - CBL-514 only. CBL-514 will be administrated with the grid spacing of 2 cm^2

Experimental: Cohort 7: CBL-514 160 mg, 2 mg/cm^2 - CBL-514 only. CBL-514 will be administrated with the grid spacing of 2 cm^2

Experimental: Cohort 8: CBL-514 240 mg, 2 mg/cm^2 - CBL-514 only. CBL-514 will be administrated with the grid spacing of 2 cm^2

Experimental: Cohort 9: CBL-514 320 mg, 2 mg/cm^2 - CBL-514 only. CBL-514 will be administrated with the grid spacing of 2 cm^2


Treatment: Drugs: CBL-514, placebo
One side of the abdominal region will receive CBL-514, while the other will receive placebo with equal volume.
Which side of the abdominal region to receive CBL-514 or placebo would be randomized.
No PK samples will be collected in this cohort.

Treatment: Drugs: CBL-514, placebo
One side of the abdominal region will receive CBL-514, while the other will receive placebo with equal volume.
Which side of the abdominal region to receive CBL-514 or placebo would be randomized.

Treatment: Drugs: CBL-514
Both sides of the abdominal region will receive CBL-514.
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)
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
Timepoint [2] 0 0
Up to 2 weeks after treatment
Primary outcome [3] 0 0
Number of participants with clinically significant abnormalities in vital signs
Timepoint [3] 0 0
Up to 2 weeks after treatment
Primary outcome [4] 0 0
Number of participants with clinically significant abnormalities in Electrocardiogram (ECG)
Timepoint [4] 0 0
Up to 2 weeks after treatment
Primary outcome [5] 0 0
Number of participants with clinically significant abnormalities in physical examination
Timepoint [5] 0 0
Up to 2 weeks after treatment
Primary outcome [6] 0 0
Number of participants with injection site reactions
Timepoint [6] 0 0
Up to 2 weeks after treatment
Secondary outcome [1] 0 0
Assess maximum concentration of CBL-514 in plasma (Cmax)
Timepoint [1] 0 0
Up to 24 hours after treatment
Secondary outcome [2] 0 0
Assess time to Cmax of CBL-514 in plasma (tmax)
Timepoint [2] 0 0
Up to 24 hours after treatment
Secondary outcome [3] 0 0
Assess area under the concentration-time curve of CBL-514 in plasma (AUC)
Timepoint [3] 0 0
Up to 24 hours after treatment
Secondary outcome [4] 0 0
Assess terminal rate constant and half-life of CBL-514 in plasma (?z and t1/2)
Timepoint [4] 0 0
Up to 24 hours after treatment
Secondary outcome [5] 0 0
Assess apparent clearance and volume of distribution of CBL-514 in plasma (CL/F and Vz/F).
Timepoint [5] 0 0
Up to 24 hours after treatment

Eligibility
Key inclusion criteria
A subject can participate in the study only if all the following criteria are met:

1. Male/female aged 18 years to 64 years old (at Screening), inclusive.

2. Body mass index >18.5 and <35 kg/m2 and body weight =50 kg at Screening and Day 1.

3. Has MWC =80.0 cm at Screening and Day 1.

4. Subcutaneous fat thickness of at least 3.00 cm (30.0 mm) by pinch method (measured by
calibrated caliper) surrounding the navel at Screening and Day 1.

5. Voluntarily signs the Informed Consent Form 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
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 =12 months of amenorrhea with a follicle stimulating hormone >40 IU/L) are
considered to be of nonchildbearing 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 =6.5% (48 mmol/mol) or fasting blood sugar
=7 mmol/L.

4. Subject has a cardiovascular disease, or shows clinically significant abnormal
findings in ECG at Screening.

5. Subject with active or prior history of malignancies (except for successfully treated
non-invasive basal cell carcinoma) or being worked-up for a possible malignancy.

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:

1. Active HIV infection: positive HIV Ag/Ab combo test;

2. 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.

3. Active hepatitis C virus (HCV) infection: positive HCV antibody.

7. Subject has abnormal skin or local skin conditions, 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 abdominal wall in the area to
be treated,

3. Skin or superficial tissue that does not lie flat on its own when the subject is
in the supine position,

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

5. Evidence of any cause of enlargement in the abdominal area other than localized
subcutaneous fat,

6. Tattoos on the area to be treated.

8. Subject who has undergone the following procedures:

1. Previous open or laparoscopic abdominal 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 to the region to be treated within 6 months before Screening.

9. Subject is on prescription or over-the-counter weight reduction medication or weight
reduction programs within 3 months before Screening.

10. Subject is undergoing chronic steroid or immunosuppressive therapy.

11. Requiring continual use of the following therapeutic agents during the study:

S-mephenytoin, terfenadine, buspirone, fexofenadine, breast cancer resistance protein
(BCRP) substrates (such as mitoxantrone, methotrexate, topotecan, nitrofurantoin,
dipyridamole, statins, etc.), cytochrome P450 3A4 inhibitor, or non-steroidal
anti-inflammatory drugs (NSAIDs). 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.

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

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

14. Subjects with inadequate liver function at Screening defined as aspartate
aminotransferase, alanine aminotransferase, alkaline phosphatase, total bilirubin, or
gamma-glutamyl transferase >1.5 × ULN. A subject with an elevated liver chemistry test
up to 1.5 × ULN at Screening should be evaluated by the Investigator to exclude
pre-existing liver disease associated with mild elevation of liver chemistry tests. If
the mild elevation is assessed by the Investigator as not clinically significant or
related to non-alcoholic fatty liver, the subject may be eligible if the follow-up
tests show an unchanged or reducing value from the initial Screening value. A subject
with marginally elevated fasting unconjugated serum bilirubin with documented
Gilbert's syndrome, and no other cause for the elevated bilirubin on investigation,
may be eligible.

15. 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. A subject with serum urea
between 1 to 1.5 × ULN at Screening, but an eGFR >60mL/min/1.73 m2 and no other renal
risk factors, should be re-tested prior to declaring the subject as eligible. The
subject may be eligible if the fasting serum creatinine is not rising nor the eGFR
falling, the urinary albumin/creatinine ratio remain <3 mg/mmol.

16. 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/11/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/08/2019
Sample size
Target
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
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 Phase 1 component of the study is a double-blind, placebo-controlled, single ascending
dose (SAD) design intended to assess the safety, tolerability, and PK of CBL-514. The SAD
part will involve 9 proposed dosing cohorts.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04699669
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04699669