A Trial of SHR6508 in Secondary Hyperparathyroidism

Secondary Hyperparathyroidism Clinical Trial

Official title:

Study on Tolerability, Pharmacokinetics and Pharmacodynamics of SHR6508 in Chinese Patients With Secondary Hyperparathyroidism of Chronic Kidney Disease Treated by Maintenance Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05221008
• Other study ID #: SHR6508-102
• Status: Completed
• Phase: Phase 1
• Start date: March 10, 2022
• Est. completion date: August 2, 2023

Study information

• Verified date: July 2023
• Source: Shanghai Hengrui Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: August 2, 2023
• Est. primary completion date: July 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Neoplasm Metastasis
• Secondary Hyperparathyroidism

Intervention

Drug:
• SHR6508;Placebo
Group A:SHR6508 low dose
• SHR6508;Placebo
Group B:SHR6508 medium dose
• SHR6508;Placebo
Group C:SHR6508 high dose
• SHR6508;Placebo
Group D:SHR6508 high dose(single dose)

Locations

Country	Name	City	State
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Hengrui Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tmax, Time of maximum observed concentration.		0 hour to 43 hours after first dose administration
Primary	Cmax, Maximum observed concentration.		0 hour to 43 hours after first dose administration
Primary	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
Primary	AUC0-8, Area under the curve from time 0 extrapolated to infinite time		0 hour to 43 hours after first dose administration
Primary	t1/2z, Terminal elimination half-life		0 hour to 43 hours after first dose administration
Primary	CLz, Total Body Clearance		0 hour to 43 hours after first dose administration
Primary	Vz, Volume of distribution based on the terminal phase		0 hour to 43 hours after first dose administration
Primary	MRT0-t, Mean residence time from time zero to the last measurable concentration.		0 hour to 43 hours after first dose administration
Primary	MRT0-8, Mean residence time from time 0 extrapolated to infinite time		0 hour to 43 hours after first dose administration
Primary	Cmax,ss : Maximum observed concentration at steady-state.		Day1-Day29(if reach steady-state)
Primary	Cmin,ss : Minimum observed concentration at steady-state		Day1-Day29(if reach steady-state)
Primary	Cav : Average concentration		Day1-Day29(if reach steady-state)
Primary	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)
Primary	AUC0-8,ss, Area under the concentration-time curve from time 0 extrapolated to infinite time at steady-state.		Day1-Day29(if reach steady-state)
Primary	Tmax,ss, Time of maximum observed concentration at steady-state.		Day1-Day29(if reach steady-state)
Primary	t1/2z,ss, Terminal elimination half-life at steady-state		Day1-Day29(if reach steady-state)
Primary	CLss, Total Body Clearance at steady-state.		Day1-Day29(if reach steady-state)
Primary	Vss, Volume of distribution based on the terminal phase at steady-state.		Day1-Day29(if reach steady-state)
Primary	MRT0-8, Mean residence time from time 0 extrapolated to infinite time.		Day1-Day29(if reach steady-state)
Primary	DF: Degree of Fluctuation		Day1-Day29(if reach steady-state)
Primary	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
Secondary	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
Secondary	Proportion of Participants to End of Study whose iPTH decreased by=30% from baseline	iPTH was tested at a central laboratory.	Day1 to Day29
Secondary	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
Secondary	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