This is a first time in Asia (FTIA) study designed to evaluate the safety, tolerability, pharmacokinetic (PK) and immunogenicity of efimosfermin alfa to healthy participants of Chinese, Japanese, and White/European ancestry.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
30
Efimosfermin alfa to be administered
Placebo to be administered
GSK Investigational Site
Auckland, New Zealand
Number of participants with Adverse Events (AEs), treatment related AEs and serious adverse events (SAEs)
Time frame: Up to 90 days
Number of participants with clinically significant changes in hematology, chemistry and urinalysis parameters
Time frame: Up to 90 days
Number of participants with clinically significant changes in 12 Lead electrocardiogram (ECG)
Time frame: Up to 90 days
Number of participants with clinically significant changes in vital signs
Time frame: Up to 90 days
Area under the serum drug concentration versus time curve from time zero to the time of the last quantifiable concentration (AUC[0-t]) of efimosfermin alfa
Time frame: Up to 90 days
Area under the serum drug concentration versus time curve from time zero extrapolated to infinity (AUC[0-inf]) of efimosfermin alfa
Time frame: Up to 90 days
Maximum observed serum drug concentration, determined directly from the serum concentration-time data (Cmax) of efimosfermin alfa
Time frame: Up to 90 days
Time to maximum observed serum drug concentration (Tmax) of efimosfermin alfa
Time frame: Up to 90 days
Apparent terminal phase half-life (t1/2) of efimosfermin alfa
Time frame: Up to 90 days
Area under the serum drug concentration versus time curve from time zero to 45 days [AUC(0-45days)] of efimosfermin alfa
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Time frame: Up to 45 days
Area under the serum drug concentration versus time curve from time zero to 60 days [AUC(0-60days)] of efimosfermin alfa
Time frame: Up to 60 days
Area under the serum drug concentration versus time curve from time zero to 90 days [AUC(0-90days)] of efimosfermin alfa
Time frame: Up to 90 days
Time of last quantifiable plasma drug concentration (Tlast) of efimosfermin alfa
Time frame: Up to 90 days
Apparent clearance (CL/F) of efimosfermin alfa
Time frame: Up to 90 days
Apparent volume of distribution (Vz/F) of efimosfermin alfa
Time frame: Up to 90 days