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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBL-514 | Drug | CBL-514 800 mg (unit dose: 2.0 mg/cm^2) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0 | Number of participants experiencing TEAEs | Day 1 to Week 4 |
| Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values |
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Inclusion Criteria:
Exclusion Criteria:
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:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Anne Sheu | Caliway Biopharmaceuticals Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DermResearch Inc | Austin | Texas | 78759 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | CBL-514 | All 10 participants enrolled in the study received a single 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CBL-514 | All 10 participants enrolled in the study received a single 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | ng/mL | 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 |
|
from enrollment until end of follow-up (Week 4)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CBL-514 | All 10 participants enrolled in the study received a single treatment with CBL-514 800 mg (unit dose: 2.0 mg/cm^2) on the abdomen (administered as multiple subcutaneous injections) on Day 1. Observation of adverse events was from Day 1 to Week 4. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site reactions | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne Sheu | Caliway Biopharmaceuticals | 886226971355 | cr@caliway.com.tw |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 18, 2021 | Apr 22, 2026 | Prot_SAP_000.pdf |
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To evaluate apparent terminal volume of distribution of CBL-514 in plasma (Vz/F) after single dose injection.
| 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 |
Clinical laboratory tests include Biochemistry, Hematology, Coagulation, Urinalysis, Virology and Pregnancy status test. |
| Up to 2 weeks after last treatment |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | hour | 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 |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | hour*ng/mL | 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 |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | hour | 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 |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | L/hour | 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 |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | L | 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 |
|
|
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| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0 | Number of participants experiencing TEAEs | Posted | Count of Participants | Participants | Day 1 to Week 4 |
|
|
|
| Secondary | Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values | Clinical laboratory tests include Biochemistry, Hematology, Coagulation, Urinalysis, Virology and Pregnancy status test. | Posted | Count of Participants | Participants | Up to 2 weeks after last treatment |
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| 0 |
| 10 |
| 0 |
| 10 |
| 10 |
| 10 |
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