This was a single ascending dose, randomized, double-blind study assessing the safety, tolerability and pharmacokinetics of STSA-1005 in healthy participants. Four kinds different doses and dose-matched placebo were administered under fasted conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
32
AltaSciences Clinical Kansas, Inc
Overland Park, Kansas, United States
Incidence of Adverse Events, Serious Adverse Events, Clinically Significant Laboratory Abnormalities, Electrocardiogram Abnormalities, Vital Signs Abnormalities and Physical Examination Abnormalities.
Time frame: Day 1 through Day 57
Maximum plasma concentration (Cmax)
To evaluate the pharmacokinetics (PK) characteristics of STSA-1005 in healthy adult subjects
Time frame: Up to 1344 hours postdose
Area under the plasma concentration-time curve from time 0 to the collection time point t of the last measurable concentration (AUC0-t)
To evaluate the pharmacokinetics (PK) characteristics of STSA-1005 in healthy adult subjects
Time frame: Up to 1344 hours postdose
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞)
To evaluate the pharmacokinetics (PK) characteristics of STSA-1005 in healthy adult subjects
Time frame: Up to 1344 hours postdose
Time of maximum concentration (Tmax)
To evaluate the pharmacokinetics (PK) characteristics of STSA-1005 in healthy adult subjects
Time frame: Up to 1344 hours postdose
Elimination half-life (t1/2)
To evaluate the pharmacokinetics (PK) characteristics of STSA-1005 in healthy adult subjects
Time frame: Up to 1344 hours postdose
Fraction of drug eliminated per unit of time (Kel)
To evaluate the pharmacokinetics (PK) characteristics of STSA-1005 in healthy adult subjects
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Intravenous injection
Intravenous injection
Intravenous injection
Intravenous injection
Intravenous injection
Time frame: Up to 1344 hours postdose
Last measurable concentration (Clast)
To evaluate the pharmacokinetics (PK) characteristics of STSA-1005 in healthy adult subjects
Time frame: Up to 1344 hours postdose
Mean residence time (MRT)
To evaluate the pharmacokinetics (PK) characteristics of STSA-1005 in healthy adult subjects
Time frame: Up to 1344 hours postdose
Clearance (CL)
To evaluate the pharmacokinetics (PK) characteristics of STSA-1005 in healthy adult subjects
Time frame: Up to 1344 hours postdose
Apparent volume of distribution (Vz/F)
To evaluate the pharmacokinetics (PK) characteristics of STSA-1005 in healthy adult subjects
Time frame: Up to 1344 hours postdose
The number of subjects with anti-drug antibody (ADA) and neutralizing antibody (NAb)
Time frame: Up to 1344 hours postdose
Change from baseline in numbers of neutrophils and monocytes
Time frame: Up to 1344 hours postdose
Changes of granulocyte macrophage colony-stimulating factor (GM-CSF) receptor occupancy (RO) after the administration compared with the baseline
Time frame: Up to 1344 hours postdose