This is a phase 1 open-label study.
This is a phase 1 open-label study. The objective of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of oral administered SHR8735 in healthy subjects
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
SHR8735 is an thrombopoietin receptor agonist to promote platelet production.
Linear Clinical research
Perth, Western Australia, Australia
Adverse events
Incidence and severity of adverse events
Time frame: Start of Treatment to end of study (approximately 28 days)
Pharmacokinetics-AUC0-last
Area under the concentration-time curve from time 0 to last time point after SHR8735 administration
Time frame: Start of Treatment to end of study (approximately 15 days)
Pharmacokinetics-AUC0-inf
Area under the concentration-time curve from time 0 to infinity after SHR8735 administration
Time frame: Start of Treatment to end of study (approximately 15 days)
Pharmacokinetics-Tmax
Time to Cmax of SHR8735
Time frame: Up to 15 days
Pharmacokinetics-Cmax
Maximum observed concentration of SHR8735
Time frame: Up to 15 days
Pharmacokinetics-CL/F
Apparent clearance of SHR8735
Time frame: Up to 15 days
Pharmacokinetics-Vz/F
Apparent volume of distribution during terminal phase of SHR8735
Time frame: Up to 15 days
Pharmacokinetics-t1/2
Terminal elimination half-life of SHR8735
Time frame: Up to 15 days
Change from baseline to end of treatment for platelet count
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Up to 28 days