The Phase 1 component of the study is a double-blind, placebo-controlled, single ascending dose (SAD) design intended to assess the safety, tolerability, and PK of CBL-514. The SAD part will involve 9 proposed dosing cohorts.
The Phase 1 part of the study was a first-in-human, single ascending dose, double-blind, randomized (except Cohorts 6 to 9 \[open-label\]) study in healthy subjects to evaluate the safety, tolerability and PK of CBL-514, and to determine the dose levels to be used for the Phase 2a part of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
One side of the abdominal region will receive CBL-514, while the other will receive placebo with equal volume. Which side of the abdominal region to receive CBL-514 or placebo would be randomized. No PK samples will be collected in this cohort.
One side of the abdominal region will receive CBL-514, while the other will receive placebo with equal volume. Which side of the abdominal region to receive CBL-514 or placebo would be randomized.
Both sides of the abdominal region will receive CBL-514.
Investigational site
Melbourne, Australia
Incidence of treatment emergent adverse events (TEAEs)
Number of participants experiencing TEAEs and number of individual TEAEs among treatment groups by severity and relationship to investigational product (IP)
Time frame: Up to 4 weeks after treatment
Number of participants with clinically significant abnormalities in clinical laboratory values
Clinical laboratory tests include Biochemistry, Hematology, Coagulation and Urinalysis testinjection site reactions.
Time frame: Up to 2 weeks after treatment
Number of participants with clinically significant abnormalities in vital signs
Vital signs measurements include temperature, pulse rate, blood pressure, and respiratory rate
Time frame: Up to 2 weeks after treatment
Number of participants with clinically significant abnormalities in Electrocardiogram (ECG)
ECG parameters include heart rate, RR interval, PR interval, QT interval, QTc interval, and QRS interval
Time frame: Up to 2 weeks after treatment
Number of participants with clinically significant abnormalities in physical examination
Physical examinations include assessment of cardiovascular, respiratory, gastrointestinal, and neurological systems
Time frame: Up to 2 weeks after treatment
Number of participants with injection site reactions
Injection site reactions include but not limited to redness, swelling, bruising, tenderness, itching, pain, warmth, discoloration and hardness
Time frame: Up to 2 weeks after treatment
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Assess maximum concentration of CBL-514 in plasma (Cmax)
To evaluate maximum concentration of CBL-514 in plasma (Cmax) after single dose injection.
Time frame: Up to 24 hours after treatment
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: Up to 24 hours after treatment
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: Up to 24 hours after treatment
Assess terminal rate constant and half-life of CBL-514 in plasma (λz and t1/2)
To evaluate terminal rate constant and half-life of CBL-514 in plasma (λz and t1/2) after single dose injection.
Time frame: Up to 24 hours after treatment
Assess apparent clearance and volume of distribution of CBL-514 in plasma (CL/F and Vz/F).
To evaluate apparent clearance and volume of distribution of CBL-514 in plasma (CL/F and Vz/F) after single dose injection.
Time frame: Up to 24 hours after treatment