Subcutaneous FatPhase 2NCT05234736
A Study to Evaluate the Pharmacokinetic Profile of CBL-514 Injection in Healthy Volunteers
A Phase 2 study testing CBL-514 in people with Subcutaneous Fat, run by Caliway Biopharmaceuticals Co., Ltd. at 1 site in United States.
Trial summary
This Phase 2 study will be an open-label and single course study to assess the safety, tolerability, PK and metabolite profile of CBL-514. 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2022to 9 Jun 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male/female aged 18 years to 64 years old (at Screening), inclusive.
- Body mass index (BMI) >18.5 and < 35 kg/m2 and body weight ≥ 50 kg at Screening and Day 1.
- Participant has sufficient subcutaneous fat thickness of at least 3.00 cm (30.0 mm) measured by caliper skinfold method around treatment area at Screening and Day 1.
- 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, including food and drink restrictions.
Who cannot join
- Women of childbearing potential (WOCBP) who are not willing to commit to an acceptable contraceptive regimen from the time of Screening and throughout study participation until 90 days after the last IP dose, or who are currently pregnant or lactating. Male participants who are not willing to commit to an acceptable contraceptive method. Female participants who are not WOCBP are not required to use contraception.
- Participant diagnosed with coagulation disorders or is receiving anticoagulant/antiplatelet therapy or medications or dietary supplements, which impede coagulation or platelet aggregation.
- Participant has hemoglobin A1c (HbA1c) ≥ 9%, delayed wound healing, or any diabetic risks which, in the opinion of Investigator, is inappropriate to participate in the study.
- Participant has a clinically significant cardiovascular disease and clinically significant abnormal findings in electrocardiogram (ECG).
- Participant 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.
- Participant with a history of human immunodeficiency virus (HIV)-1, hepatitis B, or hepatitis C infections or participants with active HIV, hepatitis B, or hepatitis C infections at Screening:
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- Participants with positive COVID-19 antigen test at Screening and Day 1.
- Participants with any hepatic medical condition that, in the opinion of the Investigator, would compromise the participant's ability to undergo study procedures and/or interfere with the assessment of the obtained data.
- Participants with a history of trypanophobia, the extreme fear of medical procedures involving injections or needles, or who experience vasovagal syncope and faint or pass out at the sight of blood or a needle.
- Participant 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:
- Participant who has the following procedures:
- Previous surgery which caused scar tissues on the anticipated treatment area before Screening or during the study,
- Liposuction to the region to be treated before Screening or during the study,
- Esthetic procedure e.g., cryolipolysis, ultrasonic lipolysis, LLLT, lipolysis injection to the region to be treated within 12 months before Screening or during the study.
- Participant is undergoing chronic systemic steroid or immunosuppressive therapy.
- Requiring continual use of the following therapeutic agents during the study: terfenadine, buspirone, fexofenadine, any medication that is known to strongly inhibit or induce CYP enzymes, sensitive CYP substrates or drugs with narrow therapeutic index, in the opinion of the Investigator, may affect the evaluation of the study product or place the participant at undue risk.
- If a participant needs to use the above-mentioned therapeutic agents during the study for any reason, these therapeutic agents should not be used for at least 2 days prior to dosing and until 1 day post-dose.
- Unable to receive local anesthesia (e.g., history of hypersensitivity to lidocaine).
- Participants with known allergies or sensitivities to the IP or its components.
- Participants with liver cirrhosis or with inadequate liver function at Screening defined as aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), total bilirubin (TBIL), or gamma-glutamyl transferase (GGT) > 3.0 × upper limit of normal (ULN).
- Participants with any renal impairment, defined as abnormal serum creatinine, and urea > 1.5 × ULN or estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73 m2. Participants who are currently on dialysis should be excluded.
- Participants with an eGFR ≥ 60 and < 90 mL/min/1.73 m2 at Screening should be evaluated by the Investigator to exclude pre-existing renal disease or associated dysfunction. If mild decrease in eGFR is assessed by the Investigator as not clinically significant or not related to dysfunction, the subjects may be eligible upon the Investigator's assessment.
- Use of other investigational drug or device within 4 weeks prior to Screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2 Study to Evaluate the Pharmacokinetic Profile of CBL-514 Injection in Healthy Volunteers
This Phase 2 study will be an open-label and single course study to assess the safety, tolerability, PK and metabolite profile of CBL-514.
Read the detailed description
This is a Phase 2 study to evaluate the safety, tolerability, PK and metabolite profile of CBL-514 injection at the maximal use dosage.
This Phase 2 study has an open-label and single course design. A total of 10 adult participants, composed of 5 females and 5 males, will be enrolled in a single cohort. Each participant will receive a single course of treatment with CBL-514 800 mg on the abdomen (administered as multiple subcutaneous injections) on Day 1 only.
- Conditions
- Subcutaneous Fat
- Being tested
- CBL-514
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBL-514Drug
CBL-514 800 mg (unit dose: 2.0 mg/cm^2)
| Study group | Role | What they receive |
|---|---|---|
| CBL-514 | Experimental | All 10 participants enrolled in the study will receive a single course of treatment with CBL-514 800 mg (unit dose: 2.0 mg/cm^2) on the abdomen (administered as multiple subcutaneous injections) on Day 1 only. Receives: Drug: CBL-514 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess Maximum Analyte Concentration of CBL-514 in Plasma (Cmax)
To evaluate maximum analyte concentration of CBL-514 in plasma (Cmax) after single dose injection.
Measured: pre-dose, 1 hour, 2 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 18 hours, and 24 hours post-dose
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: pre-dose, 1 hour, 2 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 18 hours, and 24 hours post-dose
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: pre-dose, 1 hour, 2 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 18 hours, and 24 hours post-dose
Assess Elimination Half-life of CBL-514 in Plasma (t1/2)
To evaluate elimination half-life of CBL-514 in plasma (t1/2) after single dose injection.
Measured: pre-dose, 1 hour, 2 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 18 hours, and 24 hours post-dose
Assess Apparent Total Plasma Clearance of CBL-514 in Plasma (CL/F).
To evaluate apparent total plasma clearance of CBL-514 (CL/F) after single dose injection.
Measured: pre-dose, 1 hour, 2 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 18 hours, and 24 hours post-dose
Assess Apparent Terminal Volume of Distribution of CBL-514 in Plasma (Vz/F).
To evaluate apparent terminal volume of distribution of CBL-514 in plasma (Vz/F) after single dose injection.
Measured: pre-dose, 1 hour, 2 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 18 hours, and 24 hours post-dose
Secondary outcomes (2)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0
Number of participants experiencing TEAEs
Measured: Day 1 to Week 4
Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values
Clinical laboratory tests include Biochemistry, Hematology, Coagulation, Urinalysis, Virology and Pregnancy status test.
Measured: Up to 2 weeks after last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start11 Feb 2022
- Primary completion9 Jun 2022
- Study completion9 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Subcutaneous FatStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Caliway Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anne Sheu, Study director, Caliway Biopharmaceuticals Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05234736
- Sponsor's protocol ID
- CBL-0203
- Status last verified
- May 2026
- First submitted
- 23 Dec 2021
- Last updated
- 22 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study to Evaluate the Pharmacokinetic Profile of CBL-514 Injection in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05234736
- Acronym / sponsor ID
- CBL-0203
- Conditions
- Subcutaneous Fat
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Caliway Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Feb 2022 (actual)
- Primary completion
- 9 Jun 2022 (actual)
- Study completion
- 9 Jun 2022 (actual)
- First posted
- 10 Feb 2022 (actual)
- Results
- Posted 22 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 2 study will be an open-label and single course study to assess the safety, tolerability, PK and metabolite profile of CBL-514.
Detailed description
This is a Phase 2 study to evaluate the safety, tolerability, PK and metabolite profile of CBL-514 injection at the maximal use dosage.
This Phase 2 study has an open-label and single course design. A total of 10 adult participants, composed of 5 females and 5 males, will be enrolled in a single cohort. Each participant will receive a single course of treatment with CBL-514 800 mg on the abdomen (administered as multiple subcutaneous injections) on Day 1 only.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CBL-514 | Experimental | Drug: CBL-514All 10 participants enrolled in the study will receive a single course of treatment with CBL-514 800 mg (unit dose: 2.0 mg/cm^2) on the abdomen (administered as multiple subcutaneous injections) on Day 1 only. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male/female aged 18 years to 64 years old (at Screening), inclusive.
- Body mass index (BMI) >18.5 and < 35 kg/m2 and body weight ≥ 50 kg at Screening and Day 1.
- Participant has sufficient subcutaneous fat thickness of at least 3.00 cm (30.0 mm) measured by caliper skinfold method around treatment area at Screening and Day 1.
- 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, including food and drink restrictions.
Key exclusion criteria (23 listed)
- Women of childbearing potential (WOCBP) who are not willing to commit to an acceptable contraceptive regimen from the time of Screening and throughout study participation until 90 days after the last IP dose, or who are currently pregnant or lactating. Male participants who are not willing to commit to an acceptable contraceptive method. Female participants who are not WOCBP are not required to use contraception.
- Participant diagnosed with coagulation disorders or is receiving anticoagulant/antiplatelet therapy or medications or dietary supplements, which impede coagulation or platelet aggregation.
- Participant has hemoglobin A1c (HbA1c) ≥ 9%, delayed wound healing, or any diabetic risks which, in the opinion of Investigator, is inappropriate to participate in the study.
- Participant has a clinically significant cardiovascular disease and clinically significant abnormal findings in electrocardiogram (ECG).
- Participant 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBL-514CBL-514 800 mg (unit dose: 2.0 mg/cm^2) | Drug | CBL-514 |
Primary outcome
Assess Maximum Analyte Concentration of CBL-514 in Plasma (Cmax)
Time frame: pre-dose, 1 hour, 2 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 18 hours, and 24 hours post-dose
To evaluate maximum analyte concentration of CBL-514 in plasma (Cmax) after single dose injection.
Assess Time to Cmax of CBL-514 in Plasma (Tmax)
Time frame: pre-dose, 1 hour, 2 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 18 hours, and 24 hours post-dose
To evaluate time to Cmax of CBL-514 in plasma (tmax) after single dose injection.
Assess Area Under the Concentration-time Curve of CBL-514 in Plasma (AUC)
Time frame: pre-dose, 1 hour, 2 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 18 hours, and 24 hours post-dose
To evaluate area under the concentration-time curve of CBL-514 in plasma (AUC) after single dose injection.
Assess Elimination Half-life of CBL-514 in Plasma (t1/2)
Time frame: pre-dose, 1 hour, 2 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 18 hours, and 24 hours post-dose
To evaluate elimination half-life of CBL-514 in plasma (t1/2) after single dose injection.
Assess Apparent Total Plasma Clearance of CBL-514 in Plasma (CL/F).
Time frame: pre-dose, 1 hour, 2 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 18 hours, and 24 hours post-dose
To evaluate apparent total plasma clearance of CBL-514 (CL/F) after single dose injection.
Assess Apparent Terminal Volume of Distribution of CBL-514 in Plasma (Vz/F).
Time frame: pre-dose, 1 hour, 2 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 18 hours, and 24 hours post-dose
To evaluate apparent terminal volume of distribution of CBL-514 in plasma (Vz/F) after single dose injection.
2 secondary outcomes
Number of Participants With Treatment-emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0
Time frame: Day 1 to Week 4
Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values
Time frame: Up to 2 weeks after last treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Sheu study director
Caliway Biopharmaceuticals Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CBL-514 in people with Subcutaneous Fat, run by Caliway Biopharmaceuticals Co., Ltd. at 1 site in United States.
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 4 inclusion and 23 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 22 May 2026. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Assess Maximum Analyte Concentration of CBL-514 in Plasma (Cmax) (time frame: pre-dose, 1 hour, 2 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 18 hours, and 24 hours post-dose). 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?
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 22 May 2026.