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Clinical Trial Details

Trial ID: L1710
Source ID: NCT05221008
Associated Drug: Shr6508;Placebo
Title: A Trial of SHR6508 in Secondary Hyperparathyroidism
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Secondary Hyperparathyroidism
Interventions: DRUG: SHR6508;Placebo|DRUG: SHR6508;Placebo|DRUG: SHR6508;Placebo|DRUG: SHR6508;Placebo
Outcome Measures: Primary: Tmax, Time of maximum observed concentration., 0 hour to 43 hours after first dose administration|Cmax, Maximum observed concentration., 0 hour to 43 hours after first dose administration|AUC0-t, Area under the concentration-time curve from time zero to the last measurable concentration., 0 hour to 43 hours after first dose administration|AUC0-∞, Area under the curve from time 0 extrapolated to infinite time, 0 hour to 43 hours after first dose administration|t1/2z, Terminal elimination half-life, 0 hour to 43 hours after first dose administration|CLz, Total Body Clearance, 0 hour to 43 hours after first dose administration|Vz, Volume of distribution based on the terminal phase, 0 hour to 43 hours after first dose administration|MRT0-t, Mean residence time from time zero to the last measurable concentration., 0 hour to 43 hours after first dose administration|MRT0-∞, Mean residence time from time 0 extrapolated to infinite time, 0 hour to 43 hours after first dose administration|Cmax,ss : Maximum observed concentration at steady-state., Day1-Day29(if reach steady-state)|Cmin,ss : Minimum observed concentration at steady-state, Day1-Day29(if reach steady-state)|Cav : Average concentration, Day1-Day29(if reach steady-state)|AUC0-t,ss, Area under the concentration-time curve from time zero to the last measurable concentration at steady-state., Day1-Day29(if reach steady-state)|AUC0-∞,ss, Area under the concentration-time curve from time 0 extrapolated to infinite time at steady-state., Day1-Day29(if reach steady-state)|Tmax,ss, Time of maximum observed concentration at steady-state., Day1-Day29(if reach steady-state)|t1/2z,ss, Terminal elimination half-life at steady-state, Day1-Day29(if reach steady-state)|CLss, Total Body Clearance at steady-state., Day1-Day29(if reach steady-state)|Vss, Volume of distribution based on the terminal phase at steady-state., Day1-Day29(if reach steady-state)|MRT0-∞, Mean residence time from time 0 extrapolated to infinite time., Day1-Day29(if reach steady-state)|DF: Degree of Fluctuation, Day1-Day29(if reach steady-state)|Accumulation Ratio, Day1-Day29(if reach steady-state) | Secondary: Change From Baseline in serum iPTH, cCa, P, FGF23 and BSAP, iPTH, FGF23 and BSAP were tested at a central laboratory., 0 hour to 43 hours after first dose administration|Change From Baseline to End of Study in serum iPTH, cCa, P, FGF23 and BSAP, iPTH, FGF23 and BSAP were tested at a central laboratory., Day1 to Day29|Proportion of Participants to End of Study whose iPTH decreased by≥30% from baseline, iPTH was tested at a central laboratory., Day1 to Day29|Proportion of Participants to End of Study whose iPTH decreased to 300 pg/mL from baseline, iPTH was tested at a central laboratory, Day1 to Day29|Participants With Treatment-Emergent Adverse Events (TEAEs), Terms were coded with Medical Dictionary for Regulatory Activities (MedDRA), Day1 to End of Study, End of Study is about Day55
Sponsor/Collaborators: Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 54
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2022-03-10
Completion Date: 2023-08-02
Results First Posted:
Last Update Posted: 2023-08-08
Locations: Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China
URL: https://clinicaltrials.gov/show/NCT05221008