Phase 2
N=10
A Study to Evaluate the Pharmacokinetic Profile of CBL-514 Injection in Healthy Volunteers
Subcutaneous Fat
Bottom Line
View on ClinicalTrials.gov: NCT05234736 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Assess Maximum Analyte Concentration of CBL-514 in Plasma (Cmax) — 137.6; 79.5 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CBL-514 (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Caliway Biopharmaceuticals Co., Ltd.
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assess Maximum Analyte Concentration of CBL-514 in Plasma (Cmax) |
137.6; 79.5 | — |
| PRIMARY Assess Time to Cmax of CBL-514 in Plasma (Tmax) |
7.4; 7.4 | — |
| PRIMARY Assess Area Under the Concentration-time Curve of CBL-514 in Plasma (AUC) |
881.4; 1005.0 | — |
| PRIMARY Assess Elimination Half-life of CBL-514 in Plasma (t1/2) |
3.3; 7.2 | — |
| PRIMARY Assess Apparent Total Plasma Clearance of CBL-514 in Plasma (CL/F). |
767.2; 136.1 | — |
| PRIMARY Assess Apparent Terminal Volume of Distribution of CBL-514 in Plasma (Vz/F). |
3752.7; 1255.2 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0 |
10 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- Male/female aged 18 years to 64 years old (at Screening), inclusive.
- Body mass index (BMI) >18.5 and 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.
Data sourced from ClinicalTrials.gov (NCT05234736). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.