A Trial of SHR6508 in Secondary Hyperparathyroidism

Phase 1

Completed

• Conditions: Secondary Hyperparathyroidism
• Interventions: Drug: SHR6508；Placebo

• Registration Number: NCT05221008
• Lead Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-07
• Study First Submitted QC: 2022-01-20
• Study First Posted: 2022-02-02
• Study Start: 2022-03-10
• Status Verified: 2023-07
• Primary Completion: 2023-07-07
• Study Completion: 2023-08-02
• Last Update Submitted: 2023-08-07
• Last Update Posted: 2023-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group B	SHR6508；Placebo	Experimental: SHR6508 Placebo Comparator: normal saline
group A	SHR6508；Placebo	Experimental: SHR6508 Placebo Comparator: normal saline
group C	SHR6508；Placebo	Experimental: SHR6508 Placebo Comparator: normal saline
group D	SHR6508；Placebo	Experimental: SHR6508 Placebo Comparator: normal saline

Primary Outcome Measures

Name	Time	Method
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,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-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
CLz, Total Body Clearance	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
AUC0-∞,ss, Area under the concentration-time curve from time 0 extrapolated to infinite time 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)
DF: Degree of Fluctuation	Day1-Day29(if reach steady-state)
t1/2z, Terminal elimination half-life	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
Cmax,ss : Maximum observed concentration at steady-state.	Day1-Day29(if reach steady-state)
Cav : Average concentration	Day1-Day29(if reach steady-state)
MRT0-∞, Mean residence time from time 0 extrapolated to infinite time.	Day1-Day29(if reach steady-state)
Cmin,ss : Minimum observed concentration 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)
MRT0-∞, Mean residence time from time 0 extrapolated to infinite time	0 hour to 43 hours after first dose administration
Accumulation Ratio	Day1-Day29(if reach steady-state)

Secondary Outcome Measures

Name	Time	Method
Change From Baseline to End of Study in serum iPTH, cCa, P, FGF23 and BSAP	Day1 to Day29	iPTH, FGF23 and BSAP were tested at a central laboratory.
Proportion of Participants to End of Study whose iPTH decreased to 300 pg/mL from baseline	Day1 to Day29	iPTH was tested at a central laboratory
Participants With Treatment-Emergent Adverse Events (TEAEs)	Day1 to End of Study, End of Study is about Day55	Terms were coded with Medical Dictionary for Regulatory Activities (MedDRA)
Change From Baseline in serum iPTH, cCa, P, FGF23 and BSAP	0 hour to 43 hours after first dose administration	iPTH, FGF23 and BSAP were tested at a central laboratory.
Proportion of Participants to End of Study whose iPTH decreased by≥30% from baseline	Day1 to Day29	iPTH was tested at a central laboratory.

Trial Locations

Locations (1)

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China