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Subcutaneous FatPhase 1NCT04699669

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

A Phase 1 study testing CBL-514 in people with Subcutaneous Fat, run by Caliway Biopharmaceuticals Co., Ltd. at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for
Subcutaneous Fat
What is being tested?
CBL-514
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteAustralia
Study dates
27 Nov 2018to 20 Aug 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • A subject can participate in the study only if all the following criteria are met:
  • Male/female aged 18 years to 64 years old (at Screening), inclusive.
  • Body mass index >18.5 and <35 kg/m2 and body weight ≥50 kg at Screening and Day 1.
  • Has MWC ≥80.0 cm at Screening and Day 1.
  • 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.
  • 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.

Who cannot join

  • A subject who meets any of the following criteria will not be eligible to enter the study:
  • 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.
  • Subject diagnosed with coagulation disorders or is receiving anticoagulant/antiplatelet therapy or medications or dietary supplements, which impede coagulation or platelet aggregation.
  • Subject has diabetes or glycated hemoglobin ≥6.5% (48 mmol/mol) or fasting blood sugar ≥7 mmol/L.
  • Subject has a cardiovascular disease, or shows clinically significant abnormal findings in ECG at Screening.
  • 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.
Show all 32Show fewer
  • 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:
  • Active HIV infection: positive HIV Ag/Ab combo test;
  • 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.
  • Active hepatitis C virus (HCV) infection: positive HCV antibody.
  • 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:
  • Skin manifestations of a systemic disease,
  • Any abnormality of the skin or soft tissues of the abdominal wall in the area to be treated,
  • Skin or superficial tissue that does not lie flat on its own when the subject is in the supine position,
  • Sensory loss or dysesthesia in the area to be treated,
  • Evidence of any cause of enlargement in the abdominal area other than localized subcutaneous fat,
  • Tattoos on the area to be treated.
  • Subject who has undergone the following procedures:
  • Previous open or laparoscopic abdominal surgery in the anticipated treatment area,
  • Cardiac pacemakers or any implantable electrical device,
  • Metal implants of any type in the area to be treated,
  • Esthetic procedure to the region to be treated within 6 months before Screening.
  • Subject is on prescription or over-the-counter weight reduction medication or weight reduction programs within 3 months before Screening.
  • Subject is undergoing chronic steroid or immunosuppressive therapy.
  • 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.
  • Unable to receive topical anesthesia (e.g., history of hypersensitivity to lidocaine).
  • Subjects with known allergies or sensitivities to the study drug and/or excipients.
  • 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.
  • 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.
  • Use of other investigational drug or device within 4 weeks prior to Screening.

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Investigational site

    Melbourne

Other trials in Australia

About this study

Official 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)

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.

Read the detailed description

The Phase 1 part of the study was a first-in-human, single ascending dose, double-blind, randomized (except Cohorts 6 to 9 [open-label]) study in healthy subjects to evaluate the safety, tolerability and PK of CBL-514, and to determine the dose levels to be used for the Phase 2a part of the study.

Being tested
CBL-514, placebo, CBL-514

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CBL-514, placeboDrug

    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.

  • CBL-514, placeboDrug

    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.

  • CBL-514Drug

    Both sides of the abdominal region will receive CBL-514.

Study groups in NCT04699669
Study groupRoleWhat they receive
Cohort 1: CBL-514 2 mg, 0.5 mg/cm^2OtherIndividual placebo control. CBL-514 will be administrated with the grid spacing of 4 cm^2
Receives: Drug: CBL-514, placebo
Cohort 2: CBL-514 10 mg, 0.5 mg/cm^2OtherIndividual placebo control. CBL-514 will be administrated with the grid spacing of 4 cm^2
Receives: Drug: CBL-514, placebo
Cohort 3: CBL-514 20 mg, 0.5 mg/cm^2OtherIndividual placebo control. CBL-514 will be administrated with the grid spacing of 4 cm^2
Receives: Drug: CBL-514, placebo
Cohort 4: CBL-514 40 mg, 1.0 mg/cm^2OtherIndividual placebo control. CBL-514 will be administrated with the grid spacing of 4 cm^2
Receives: Drug: CBL-514, placebo
Cohort 5: CBL-514 40 mg, 2 mg/cm^2OtherIndividual placebo control. CBL-514 will be administrated with the grid spacing of 2 cm^2
Receives: Drug: CBL-514, placebo
Cohort 6: CBL-514 80 mg, 2 mg/cm^2ExperimentalCBL-514 only. CBL-514 will be administrated with the grid spacing of 2 cm^2
Receives: Drug: CBL-514
Cohort 7: CBL-514 160 mg, 2 mg/cm^2ExperimentalCBL-514 only. CBL-514 will be administrated with the grid spacing of 2 cm^2
Receives: Drug: CBL-514
Cohort 8: CBL-514 240 mg, 2 mg/cm^2ExperimentalCBL-514 only. CBL-514 will be administrated with the grid spacing of 2 cm^2
Receives: Drug: CBL-514
Cohort 9: CBL-514 320 mg, 2 mg/cm^2ExperimentalCBL-514 only. CBL-514 will be administrated with the grid spacing of 2 cm^2
Receives: Drug: CBL-514

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Up to 4 weeks after treatment

  2. Number of participants with clinically significant abnormalities in clinical laboratory values

    Clinical laboratory tests include Biochemistry, Hematology, Coagulation and Urinalysis testinjection site reactions.

    Measured: Up to 2 weeks after treatment

  3. Number of participants with clinically significant abnormalities in vital signs

    Vital signs measurements include temperature, pulse rate, blood pressure, and respiratory rate

    Measured: Up to 2 weeks after treatment

  4. 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

    Measured: Up to 2 weeks after treatment

  5. Number of participants with clinically significant abnormalities in physical examination

    Physical examinations include assessment of cardiovascular, respiratory, gastrointestinal, and neurological systems

    Measured: Up to 2 weeks after treatment

  6. 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

    Measured: Up to 2 weeks after treatment

Secondary outcomes (5)

  1. Assess maximum concentration of CBL-514 in plasma (Cmax)

    To evaluate maximum concentration of CBL-514 in plasma (Cmax) after single dose injection.

    Measured: Up to 24 hours after treatment

  2. Assess time to Cmax of CBL-514 in plasma (tmax)

    To evaluate time to Cmax of CBL-514 in plasma (tmax) after single dose injection.

    Measured: Up to 24 hours after treatment

  3. Assess area under the concentration-time curve of CBL-514 in plasma (AUC)

    To evaluate area under the concentration-time curve of CBL-514 in plasma (AUC) after single dose injection.

    Measured: Up to 24 hours after treatment

  4. Assess terminal rate constant and half-life of CBL-514 in plasma (λz and t1/2)

    To evaluate terminal rate constant and half-life of CBL-514 in plasma (λz and t1/2) after single dose injection.

    Measured: Up to 24 hours after treatment

  5. Assess apparent clearance and volume of distribution of CBL-514 in plasma (CL/F and Vz/F).

    To evaluate apparent clearance and volume of distribution of CBL-514 in plasma (CL/F and Vz/F) after single dose injection.

    Measured: Up to 24 hours after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2021
  2. Study start27 Nov 2018
  3. Primary completion20 Aug 2019
  4. Study completion20 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04699669
Sponsor's protocol ID
CBL-16001(Phase 1)
Status last verified
Jan 2021
First submitted
29 Dec 2020
Last updated
7 Jan 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CBL-514 in people with Subcutaneous Fat, run by Caliway Biopharmaceuticals Co., Ltd. at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment emergent adverse events (TEAEs) (time frame: Up to 4 weeks after treatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04699669.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2021.

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Clinical Trial NCT04699669 | AzTrials