Trial results for a Phase 2 study evaluating the pharmacokinetic (PK) profile of CBL-514 injection in healthy volunteers were posted on ClinicalTrials.gov on 2026-05-22. The study characterized key PK parameters for CBL-514, including a mean maximum analyte concentration (Cmax) for its curcumin component of 137.6 ng/mL.
Background
The Phase 2 study aimed to assess the safety, tolerability, and pharmacokinetic (PK) and metabolite profile of CBL-514 injection. The investigation focused on understanding how the drug behaves in the body, specifically its absorption, distribution, metabolism, and excretion, in healthy individuals.
Trial design
The completed Phase 2 study (NCT05234736) was an open-label, single-course investigation that enrolled 10 healthy volunteers. The study's primary objective was to evaluate the pharmacokinetic profile of CBL-514 injection, along with its safety, tolerability, and metabolite profile.
Key results
The study characterized the pharmacokinetic profile of CBL-514, detailing parameters for its curcumin and resveratrol components:
- Maximum Analyte Concentration (Cmax) in Plasma:
- For Curcumin of CBL-514, the mean Cmax was 137.6 ng/mL (Standard Deviation: 42.6 ng/mL).
- For Resveratrol of CBL-514, the mean Cmax was 79.5 ng/mL (Standard Deviation: 18.0 ng/mL).
- Time to Cmax (Tmax) in Plasma:
- For Curcumin of CBL-514, the mean Tmax was 7.4 hours (Standard Deviation: 1.6 hours).
- For Resveratrol of CBL-514, the mean Tmax was 7.4 hours (Standard Deviation: 1.8 hours).
- Area Under the Concentration-time Curve (AUC) in Plasma:
- For Curcumin of CBL-514, the mean AUC was 881.4 hour*ng/mL (Standard Deviation: 220.1 hour*ng/mL).
- For Resveratrol of CBL-514, the mean AUC was 1005.0 hour*ng/mL (Standard Deviation: 178.8 hour*ng/mL).
- Elimination Half-life (t1/2) in Plasma:
- For Curcumin of CBL-514, the mean t1/2 was 3.3 hours (Standard Deviation: 0.9 hours).
- For Resveratrol of CBL-514, the mean t1/2 was 7.2 hours (Standard Deviation: 2.0 hours).
- Apparent Total Plasma Clearance (CL/F):
- For Curcumin of CBL-514, the mean CL/F was 767.2 L/hour (Standard Deviation: 253.8 L/hour).
- For Resveratrol of CBL-514, the mean CL/F was 136.1 L/hour (Standard Deviation: 20.1 L/hour).
- Apparent Terminal Volume of Distribution (Vz/F):
- For Curcumin of CBL-514, the mean Vz/F was 3752.7 L (Standard Deviation: 1922.7 L).
- For Resveratrol of CBL-514, the mean Vz/F was 1255.2 L (Standard Deviation: 290.5 L).
What this means
The results from this Phase 2 study provide a comprehensive pharmacokinetic profile for CBL-514 and its components, curcumin and resveratrol, in healthy volunteers. Characterizing these parameters, such as Cmax, Tmax, AUC, t1/2, CL/F, and Vz/F, is fundamental for the continued development of CBL-514. This data helps in understanding the drug's absorption, distribution, metabolism, and excretion, which is essential for determining appropriate dosing regimens and predicting drug behavior in future clinical trials or potential therapeutic applications.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05234736, titled "A Study to Evaluate the Pharmacokinetic Profile of CBL-514 Injection in Healthy Volunteers", were posted on 2026-05-22 on clinicaltrials.gov.