Clinical trial NCT05221008: A Trial of SHR6508 in Secondary Hyperparathyroidism
Official title: Study on Tolerability, Pharmacokinetics and Pharmacodynamics of SHR6508 in Chinese Patients With Secondary Hyperparathyroidism of Chronic Kidney Disease Treated by Maintenance Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Secondary Hyperparathyroidism
Lead sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-02-02
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: SHR6508 compared with placebo
Primary purpose: TREATMENT

Brief summary: The study is being conducted to evaluate the tolerability, pharmacokinetics and pharmacodynamics of SHR6508 for Chinese patients with secondary hyperparathyroidism of chronic kidney disease treated by maintenance hemodialysis


Eligibility criteria: Inclusion Criteria:

1. Able and willing to provide a written informed consent
2. Diagnosed with end stage renal disease receiving stable hemodialysis
3. Male or female
4. Meet the Body Mass Index standard
5. Conform to the ASA Physical Status Classification
6. Stably use of concomitant medication of other therapies of SHPT
7. Meet the standard of iPTH level, cCa and HB

Exclusion Criteria:

1. Subjects with a history of malignant tumor
2. Subjects with neuropsychiatric diseases
3. Subjects with a history of cardiovascular diseases
4. Subjects with gastrointestinal diseases
5. Subjects with a history of surgery
6. Subjects with a history of blood loss
7. Subjects with a history of parathyroidectomy or planned during the study
8. Subjects with a history of kidney transplant or planned during the study
9. Abnormal blood pressure, serum magnesium, serum transaminase, serum albumin, platelet counts.
10. Subjects with a treatment history of similar drugs
11. Allergic to a drug ingredient or component
12. Pregnant or nursing women
13. No birth control during the specified period of time
14. Subject with a history of alcohol abuse and drug abuse
15. Participated in clinical trials of other drugs (received experimental drugs)
16. The investigators determined that other conditions were inappropriate for participation in this clinical trial

Primary outcomes:
measure: Tmax, Time of maximum observed concentration.
timeFrame: 0 hour to 43 hours after first dose administration
measure: Cmax, Maximum observed concentration.
timeFrame: 0 hour to 43 hours after first dose administration
measure: AUC0-t, Area under the concentration-time curve from time zero to the last measurable concentration.
timeFrame: 0 hour to 43 hours after first dose administration
measure: AUC0-∞, Area under the curve from time 0 extrapolated to infinite time
timeFrame: 0 hour to 43 hours after first dose administration
measure: t1/2z, Terminal elimination half-life
timeFrame: 0 hour to 43 hours after first dose administration
measure: CLz, Total Body Clearance
timeFrame: 0 hour to 43 hours after first dose administration
measure: Vz, Volume of distribution based on the terminal phase
timeFrame: 0 hour to 43 hours after first dose administration
measure: MRT0-t, Mean residence time from time zero to the last measurable concentration.
timeFrame: 0 hour to 43 hours after first dose administration
measure: MRT0-∞, Mean residence time from time 0 extrapolated to infinite time
timeFrame: 0 hour to 43 hours after first dose administration
measure: Cmax,ss : Maximum observed concentration at steady-state.
timeFrame: Day1-Day29(if reach steady-state)
measure: Cmin,ss : Minimum observed concentration at steady-state
timeFrame: Day1-Day29(if reach steady-state)
measure: Cav : Average concentration
timeFrame: Day1-Day29(if reach steady-state)
measure: AUC0-t,ss, Area under the concentration-time curve from time zero to the last measurable concentration at steady-state.
timeFrame: Day1-Day29(if reach steady-state)
measure: AUC0-∞,ss, Area under the concentration-time curve from time 0 extrapolated to infinite time at steady-state.
timeFrame: Day1-Day29(if reach steady-state)
measure: Tmax,ss, Time of maximum observed concentration at steady-state.
timeFrame: Day1-Day29(if reach steady-state)
measure: t1/2z,ss, Terminal elimination half-life at steady-state
timeFrame: Day1-Day29(if reach steady-state)
measure: CLss, Total Body Clearance at steady-state.
timeFrame: Day1-Day29(if reach steady-state)
measure: Vss, Volume of distribution based on the terminal phase at steady-state.
timeFrame: Day1-Day29(if reach steady-state)
measure: MRT0-∞, Mean residence time from time 0 extrapolated to infinite time.
timeFrame: Day1-Day29(if reach steady-state)
measure: DF: Degree of Fluctuation
timeFrame: Day1-Day29(if reach steady-state)
measure: Accumulation Ratio
timeFrame: Day1-Day29(if reach steady-state)
Secondary outcomes:
measure: Change From Baseline in serum iPTH, cCa, P, FGF23 and BSAP
timeFrame: 0 hour to 43 hours after first dose administration
measure: Change From Baseline to End of Study in serum iPTH, cCa, P, FGF23 and BSAP
timeFrame: Day1 to Day29
measure: Proportion of Participants to End of Study whose iPTH decreased by≥30% from baseline
timeFrame: Day1 to Day29
measure: Proportion of Participants to End of Study whose iPTH decreased to 300 pg/mL from baseline
timeFrame: Day1 to Day29
measure: Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Day1 to End of Study, End of Study is about Day55
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
References: