Trial Outcomes & Findings for A Study to Evaluate the Pharmacokinetic Profile of CBL-514 Injection in Healthy Volunteers (NCT NCT05234736)
NCT ID: NCT05234736
Last Updated: 2026-05-22
Results Overview
To evaluate maximum analyte concentration of CBL-514 in plasma (Cmax) after single dose injection.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
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
Results posted on
2026-05-22
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Pharmacokinetic Profile of CBL-514 Injection in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
CBL-514
n=10 Participants
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.
|
|---|---|
|
Age, Continuous
|
47.5 years
STANDARD_DEVIATION 10.7 • n=2 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=2 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=2 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=2 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
PRIMARY outcome
Timeframe: 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-doseTo evaluate maximum analyte concentration of CBL-514 in plasma (Cmax) after single dose injection.
Outcome measures
| Measure |
Curcumin of CBL-514
n=10 Participants
Participants received a single treatment with CBL-514 800 mg (unit dose: 2 mg/cm\^2). CBL-514 has two active pharmaceutical ingredients: curcumin and resveratrol. The pharmaceutical profiles of two APIs are presented separately.
|
Resveratrol of CBL-514
n=10 Participants
Participants received a single treatment with CBL-514 800 mg (unit dose: 2 mg/cm\^2). CBL-514 has two active pharmaceutical ingredients: curcumin and resveratrol. The pharmaceutical profiles of two APIs are presented separately.
|
|---|---|---|
|
Assess Maximum Analyte Concentration of CBL-514 in Plasma (Cmax)
|
137.6 ng/mL
Standard Deviation 42.6
|
79.5 ng/mL
Standard Deviation 18.0
|
PRIMARY outcome
Timeframe: 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-doseTo evaluate time to Cmax of CBL-514 in plasma (tmax) after single dose injection.
Outcome measures
| Measure |
Curcumin of CBL-514
n=10 Participants
Participants received a single treatment with CBL-514 800 mg (unit dose: 2 mg/cm\^2). CBL-514 has two active pharmaceutical ingredients: curcumin and resveratrol. The pharmaceutical profiles of two APIs are presented separately.
|
Resveratrol of CBL-514
n=10 Participants
Participants received a single treatment with CBL-514 800 mg (unit dose: 2 mg/cm\^2). CBL-514 has two active pharmaceutical ingredients: curcumin and resveratrol. The pharmaceutical profiles of two APIs are presented separately.
|
|---|---|---|
|
Assess Time to Cmax of CBL-514 in Plasma (Tmax)
|
7.4 hour
Standard Deviation 1.6
|
7.4 hour
Standard Deviation 1.8
|
PRIMARY outcome
Timeframe: 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-doseTo evaluate area under the concentration-time curve of CBL-514 in plasma (AUC) after single dose injection.
Outcome measures
| Measure |
Curcumin of CBL-514
n=10 Participants
Participants received a single treatment with CBL-514 800 mg (unit dose: 2 mg/cm\^2). CBL-514 has two active pharmaceutical ingredients: curcumin and resveratrol. The pharmaceutical profiles of two APIs are presented separately.
|
Resveratrol of CBL-514
n=10 Participants
Participants received a single treatment with CBL-514 800 mg (unit dose: 2 mg/cm\^2). CBL-514 has two active pharmaceutical ingredients: curcumin and resveratrol. The pharmaceutical profiles of two APIs are presented separately.
|
|---|---|---|
|
Assess Area Under the Concentration-time Curve of CBL-514 in Plasma (AUC)
|
881.4 hour*ng/mL
Standard Deviation 220.1
|
1005.0 hour*ng/mL
Standard Deviation 178.8
|
PRIMARY outcome
Timeframe: 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-doseTo evaluate elimination half-life of CBL-514 in plasma (t1/2) after single dose injection.
Outcome measures
| Measure |
Curcumin of CBL-514
n=10 Participants
Participants received a single treatment with CBL-514 800 mg (unit dose: 2 mg/cm\^2). CBL-514 has two active pharmaceutical ingredients: curcumin and resveratrol. The pharmaceutical profiles of two APIs are presented separately.
|
Resveratrol of CBL-514
n=10 Participants
Participants received a single treatment with CBL-514 800 mg (unit dose: 2 mg/cm\^2). CBL-514 has two active pharmaceutical ingredients: curcumin and resveratrol. The pharmaceutical profiles of two APIs are presented separately.
|
|---|---|---|
|
Assess Elimination Half-life of CBL-514 in Plasma (t1/2)
|
3.3 hour
Standard Deviation 0.9
|
7.2 hour
Standard Deviation 2.0
|
PRIMARY outcome
Timeframe: 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-doseTo evaluate apparent total plasma clearance of CBL-514 (CL/F) after single dose injection.
Outcome measures
| Measure |
Curcumin of CBL-514
n=10 Participants
Participants received a single treatment with CBL-514 800 mg (unit dose: 2 mg/cm\^2). CBL-514 has two active pharmaceutical ingredients: curcumin and resveratrol. The pharmaceutical profiles of two APIs are presented separately.
|
Resveratrol of CBL-514
n=10 Participants
Participants received a single treatment with CBL-514 800 mg (unit dose: 2 mg/cm\^2). CBL-514 has two active pharmaceutical ingredients: curcumin and resveratrol. The pharmaceutical profiles of two APIs are presented separately.
|
|---|---|---|
|
Assess Apparent Total Plasma Clearance of CBL-514 in Plasma (CL/F).
|
767.2 L/hour
Standard Deviation 253.8
|
136.1 L/hour
Standard Deviation 20.1
|
PRIMARY outcome
Timeframe: 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-doseTo evaluate apparent terminal volume of distribution of CBL-514 in plasma (Vz/F) after single dose injection.
Outcome measures
| Measure |
Curcumin of CBL-514
n=10 Participants
Participants received a single treatment with CBL-514 800 mg (unit dose: 2 mg/cm\^2). CBL-514 has two active pharmaceutical ingredients: curcumin and resveratrol. The pharmaceutical profiles of two APIs are presented separately.
|
Resveratrol of CBL-514
n=10 Participants
Participants received a single treatment with CBL-514 800 mg (unit dose: 2 mg/cm\^2). CBL-514 has two active pharmaceutical ingredients: curcumin and resveratrol. The pharmaceutical profiles of two APIs are presented separately.
|
|---|---|---|
|
Assess Apparent Terminal Volume of Distribution of CBL-514 in Plasma (Vz/F).
|
3752.7 L
Standard Deviation 1922.7
|
1255.2 L
Standard Deviation 290.5
|
SECONDARY outcome
Timeframe: Day 1 to Week 4Number of participants experiencing TEAEs
Outcome measures
| Measure |
Curcumin of CBL-514
n=10 Participants
Participants received a single treatment with CBL-514 800 mg (unit dose: 2 mg/cm\^2). CBL-514 has two active pharmaceutical ingredients: curcumin and resveratrol. The pharmaceutical profiles of two APIs are presented separately.
|
Resveratrol of CBL-514
Participants received a single treatment with CBL-514 800 mg (unit dose: 2 mg/cm\^2). CBL-514 has two active pharmaceutical ingredients: curcumin and resveratrol. The pharmaceutical profiles of two APIs are presented separately.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0
|
10 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 2 weeks after last treatmentClinical laboratory tests include Biochemistry, Hematology, Coagulation, Urinalysis, Virology and Pregnancy status test.
Outcome measures
| Measure |
Curcumin of CBL-514
n=10 Participants
Participants received a single treatment with CBL-514 800 mg (unit dose: 2 mg/cm\^2). CBL-514 has two active pharmaceutical ingredients: curcumin and resveratrol. The pharmaceutical profiles of two APIs are presented separately.
|
Resveratrol of CBL-514
Participants received a single treatment with CBL-514 800 mg (unit dose: 2 mg/cm\^2). CBL-514 has two active pharmaceutical ingredients: curcumin and resveratrol. The pharmaceutical profiles of two APIs are presented separately.
|
|---|---|---|
|
Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values
|
0 Participants
|
—
|
Adverse Events
CBL-514
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CBL-514
n=10 participants at risk
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.
|
|---|---|
|
General disorders
Injection site reactions
|
100.0%
10/10 • from enrollment until end of follow-up (Week 4)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER