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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
CBL-514 800 mg (unit dose: 2.0 mg/cm\^2)
DermResearch Inc
Austin, Texas, United States
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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Number of Participants With Treatment-emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0
Number of participants experiencing TEAEs
Time frame: 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.
Time frame: Up to 2 weeks after last treatment