A Phase 1 interventional study of SHR0302 in Graft-versus-host Disease, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Completed at 1 site in China. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-08.
Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 1, Interventional, and Basic science
To assess the relative bioavailability of SHR0302 oral solution and tablet in healthy subjects.
To assess the safety and tolerability of a single dose of SHR0302 oral solution and tablet.
806 studies on the registry are indexed under Graft vs Host Disease; 138 are open to participants now.
This study's enrollment of 16 is below the median of 35 across 637 interventional studies indexed under Graft vs Host Disease.
Browse Graft vs Host Disease studies →Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
SHR0302 tablets, then SHR0302 oral solution
Drug: SHR0302
SHR0302 oral solution, then SHR0302 tablets
Drug: SHR0302
SHR0302 oral solution 1 time, SHR0302 tablets 1 time
SHR0302 and its main Pk parameter, AUC0-t
Time frame: day 1 to 8
SHR0302 and its main Pk parameter, AUC0-inf
Time frame: day 1 to 8
SHR0302 and its main Pk parameter, Cmax
Time frame: day 1 to 8
Relative bioavailability (F%) value between SHR0302 oral solution and SHR0302 tablet: F% = AUC0-t (oral solution) / AUC0-t (tablet) ×100%
Time frame: day 1 to 8
SHR0302 and its main Pk parameter, Tmax (SHR0302 only)
Time frame: day 1 to 8
SHR0302 and its main Pk parameter, t1/2 (SHR0302 only)
Time frame: day 1 to 8
SHR0302 and its main Pk parameter, CL/F (SHR0302 only)
Time frame: day 1 to 8
SHR0302 and its main Pk parameter, Vz/F (SHR0302 only)
Time frame: day 1 to 8
Adverse events
Time frame: day 1 to 12
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Jiangsu HengRui Medicine Co., Ltd.