A Phase 1 interventional study of HS-20090-2 and Prolia in Postmenopausal Osteoporosis, sponsored by Shanghai Hansoh Biomedical Co., Ltd. Status unknown at 1 site in China. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-25.
Sponsored by Shanghai Hansoh Biomedical Co., Ltd · Phase 1, Interventional, and Prevention
A randomized, single-blind and parallel group study to compare the pharmacokinetic, safety and immunogenicity of HS-20090-2 60mg#1ml#and Prolia® in healthy adults.
This is a phase I, single center, randomized, single-blind and parallel group clinical trial .The primary objective is to assess the pharmacokinetic similarity of single subcutaneously injection of HS-20090-2 or Prolia® in healthy volunteers.The secondary objectives are to assess the Clinical safety and immunogenicity similarity of single subcutaneously injection of HS-20090-2 or Prolia® in healthy volunteers.
1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.
This study's planned enrollment of 174 is above the median of 95 across 1,133 interventional studies indexed under Osteoporosis.
Browse Osteoporosis studies →Shanghai Hansoh Biomedical Co., Ltd is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: HS-20090-2
Drug: Prolia
Subcutaneously injection of HS-20090-2 (60mg/1mL) once on the first day
Subcutaneously injection of Prolia® (60mg/1mL) once on the first day
Area under the plasma concentration-infinity curve (AUC0-∞ )
Area under the plasma concentration-time curve (AUC0-t ) from 0 o'clock to infinite time.
Time frame: 155days
Cmax
maximum concentration
Time frame: 155days
Adverse events(AE)
The adverse medical events that occur after the clinical trial subjects receive the test drug do not necessarily have a causal relationship with the treatment.
Time frame: 155days
ADA
percentage of subjects positive for antidrug antibody
Time frame: 155days
Nab
percentage of subjects positive for Nab
Time frame: 155days
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Shanghai Hansoh Biomedical Co., Ltd