This is a randomized, double-blind, placebo-controlled phase I bridging study to evaluate the PK, safety and tolerability of SR750 (formulation F1) in Chinese healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
Ascending single (30-100 mg) and multiple (30-60 mg twice daily \[b.i.d.\]) doses of SR750 orally
Ascending single and multiple doses of placebo orally
Shanghai Clinical Research Center Phase I Clinical Research Unit (SCRC-PCRU)
Shanghai, Shanghai Municipality, China
Cmax
Peak plasma concentration
Time frame: Up to 48 hours post-dose
Tmax
Time of peak plasma concentration
Time frame: Up to 48 hours post-dose
AUC
Area under the plasma concentration-time curve
Time frame: Up to 48 hours post-dose
CL/F
Apparent oral clearance
Time frame: Up to 48 hours post-dose
t1/2
Terminal half-life
Time frame: Up to 48 hours post-dose
Rac
Accumulation ratio
Time frame: Up to 48 hours post-dose
AE: Adverse Event
The frequency and severity of althy volunteers administrated with single and repeated oral doses of SR750 AEs
Time frame: Up to Day 7(+ 7 days) for the safety follow up post-dose
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