Back to resultsA Trial of SHR6508 in Secondary Hyperparathyroidism
Primary Purpose
Secondary Hyperparathyroidism
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
SHR6508；Placebo
SHR6508；Placebo
SHR6508；Placebo
SHR6508；Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Secondary Hyperparathyroidism
Eligibility Criteria
Inclusion Criteria:
- Able and willing to provide a written informed consent
- Diagnosed with end stage renal disease receiving stable hemodialysis
- Male or female
- Meet the Body Mass Index standard
- Conform to the ASA Physical Status Classification
- Stably use of concomitant medication of other therapies of SHPT
- Meet the standard of iPTH level, cCa and HB
Exclusion Criteria:
- Subjects with a history of malignant tumor
- Subjects with neuropsychiatric diseases
- Subjects with a history of cardiovascular diseases
- Subjects with gastrointestinal diseases
- Subjects with a history of surgery
- Subjects with a history of blood loss
- Subjects with a history of parathyroidectomy or planned during the study
- Subjects with a history of kidney transplant or planned during the study
- Abnormal blood pressure, serum magnesium, serum transaminase, serum albumin, platelet counts.
- Subjects with a treatment history of similar drugs
- Allergic to a drug ingredient or component
- Pregnant or nursing women
- No birth control during the specified period of time
- Subject with a history of alcohol abuse and drug abuse
- Participated in clinical trials of other drugs (received experimental drugs)
- The investigators determined that other conditions were inappropriate for participation in this clinical trial
Sites / Locations
- Guangdong Provincial People's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
group A
group B
group C
group D
Arm Description
Experimental: SHR6508 Placebo Comparator: normal saline
Experimental: SHR6508 Placebo Comparator: normal saline
Experimental: SHR6508 Placebo Comparator: normal saline
Experimental: SHR6508 Placebo Comparator: normal saline
Outcomes
Primary Outcome Measures
Tmax, Time of maximum observed concentration.
Cmax, Maximum observed concentration.
AUC0-t, Area under the concentration-time curve from time zero to the last measurable concentration.
AUC0-∞, Area under the curve from time 0 extrapolated to infinite time
t1/2z, Terminal elimination half-life
CLz, Total Body Clearance
Vz, Volume of distribution based on the terminal phase
MRT0-t, Mean residence time from time zero to the last measurable concentration.
MRT0-∞, Mean residence time from time 0 extrapolated to infinite time
Cmax,ss : Maximum observed concentration at steady-state.
Cmin,ss : Minimum observed concentration at steady-state
Cav : Average concentration
AUC0-t,ss, Area under the concentration-time curve from time zero to the last measurable concentration at steady-state.
AUC0-∞,ss, Area under the concentration-time curve from time 0 extrapolated to infinite time at steady-state.
Tmax,ss, Time of maximum observed concentration at steady-state.
t1/2z,ss, Terminal elimination half-life at steady-state
CLss, Total Body Clearance at steady-state.
Vss, Volume of distribution based on the terminal phase at steady-state.
MRT0-∞, Mean residence time from time 0 extrapolated to infinite time.
DF: Degree of Fluctuation
Accumulation Ratio
Secondary Outcome Measures
Change From Baseline in serum iPTH, cCa, P, FGF23 and BSAP
iPTH, FGF23 and BSAP were tested at a central laboratory.
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.
Proportion of Participants to End of Study whose iPTH decreased by≥30% from baseline
iPTH was tested at a central laboratory.
Proportion of Participants to End of Study whose iPTH decreased to 300 pg/mL from baseline
iPTH was tested at a central laboratory
Participants With Treatment-Emergent Adverse Events (TEAEs)
Terms were coded with Medical Dictionary for Regulatory Activities (MedDRA)
Full Information
NCT ID
NCT05221008
First Posted
January 7, 2022
Last Updated
August 7, 2023
Sponsor
Shanghai Hengrui Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05221008
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 10, 2022 (Actual)
Primary Completion Date
July 7, 2023 (Actual)
Study Completion Date
August 2, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Hengrui Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Hyperparathyroidism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
SHR6508 compared with placebo
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group A
Arm Type
Experimental
Arm Description
Experimental: SHR6508 Placebo Comparator: normal saline
Arm Title
group B
Arm Type
Experimental
Arm Description
Experimental: SHR6508 Placebo Comparator: normal saline
Arm Title
group C
Arm Type
Experimental
Arm Description
Experimental: SHR6508 Placebo Comparator: normal saline
Arm Title
group D
Arm Type
Experimental
Arm Description
Experimental: SHR6508 Placebo Comparator: normal saline
Intervention Type
Drug
Intervention Name(s)
SHR6508；Placebo
Intervention Description
Group A:SHR6508 low dose
Intervention Type
Drug
Intervention Name(s)
SHR6508；Placebo
Intervention Description
Group B:SHR6508 medium dose
Intervention Type
Drug
Intervention Name(s)
SHR6508；Placebo
Intervention Description
Group C:SHR6508 high dose
Intervention Type
Drug
Intervention Name(s)
SHR6508；Placebo
Intervention Description
Group D:SHR6508 high dose(single dose)
Primary Outcome Measure Information:
Title
Tmax, Time of maximum observed concentration.
Time Frame
0 hour to 43 hours after first dose administration
Title
Cmax, Maximum observed concentration.
Time Frame
0 hour to 43 hours after first dose administration
Title
AUC0-t, Area under the concentration-time curve from time zero to the last measurable concentration.
Time Frame
0 hour to 43 hours after first dose administration
Title
AUC0-∞, Area under the curve from time 0 extrapolated to infinite time
Time Frame
0 hour to 43 hours after first dose administration
Title
t1/2z, Terminal elimination half-life
Time Frame
0 hour to 43 hours after first dose administration
Title
CLz, Total Body Clearance
Time Frame
0 hour to 43 hours after first dose administration
Title
Vz, Volume of distribution based on the terminal phase
Time Frame
0 hour to 43 hours after first dose administration
Title
MRT0-t, Mean residence time from time zero to the last measurable concentration.
Time Frame
0 hour to 43 hours after first dose administration
Title
MRT0-∞, Mean residence time from time 0 extrapolated to infinite time
Time Frame
0 hour to 43 hours after first dose administration
Title
Cmax,ss : Maximum observed concentration at steady-state.
Time Frame
Day1-Day29(if reach steady-state)
Title
Cmin,ss : Minimum observed concentration at steady-state
Time Frame
Day1-Day29(if reach steady-state)
Title
Cav : Average concentration
Time Frame
Day1-Day29(if reach steady-state)
Title
AUC0-t,ss, Area under the concentration-time curve from time zero to the last measurable concentration at steady-state.
Time Frame
Day1-Day29(if reach steady-state)
Title
AUC0-∞,ss, Area under the concentration-time curve from time 0 extrapolated to infinite time at steady-state.
Time Frame
Day1-Day29(if reach steady-state)
Title
Tmax,ss, Time of maximum observed concentration at steady-state.
Time Frame
Day1-Day29(if reach steady-state)
Title
t1/2z,ss, Terminal elimination half-life at steady-state
Time Frame
Day1-Day29(if reach steady-state)
Title
CLss, Total Body Clearance at steady-state.
Time Frame
Day1-Day29(if reach steady-state)
Title
Vss, Volume of distribution based on the terminal phase at steady-state.
Time Frame
Day1-Day29(if reach steady-state)
Title
MRT0-∞, Mean residence time from time 0 extrapolated to infinite time.
Time Frame
Day1-Day29(if reach steady-state)
Title
DF: Degree of Fluctuation
Time Frame
Day1-Day29(if reach steady-state)
Title
Accumulation Ratio
Time Frame
Day1-Day29(if reach steady-state)
Secondary Outcome Measure Information:
Title
Change From Baseline in serum iPTH, cCa, P, FGF23 and BSAP
Description
iPTH, FGF23 and BSAP were tested at a central laboratory.
Time Frame
0 hour to 43 hours after first dose administration
Title
Change From Baseline to End of Study in serum iPTH, cCa, P, FGF23 and BSAP
Description
iPTH, FGF23 and BSAP were tested at a central laboratory.
Time Frame
Day1 to Day29
Title
Proportion of Participants to End of Study whose iPTH decreased by≥30% from baseline
Description
iPTH was tested at a central laboratory.
Time Frame
Day1 to Day29
Title
Proportion of Participants to End of Study whose iPTH decreased to 300 pg/mL from baseline
Description
iPTH was tested at a central laboratory
Time Frame
Day1 to Day29
Title
Participants With Treatment-Emergent Adverse Events (TEAEs)
Description
Terms were coded with Medical Dictionary for Regulatory Activities (MedDRA)
Time Frame
Day1 to End of Study, End of Study is about Day55
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Able and willing to provide a written informed consent
Diagnosed with end stage renal disease receiving stable hemodialysis
Male or female
Meet the Body Mass Index standard
Conform to the ASA Physical Status Classification
Stably use of concomitant medication of other therapies of SHPT
Meet the standard of iPTH level, cCa and HB
Exclusion Criteria:
Subjects with a history of malignant tumor
Subjects with neuropsychiatric diseases
Subjects with a history of cardiovascular diseases
Subjects with gastrointestinal diseases
Subjects with a history of surgery
Subjects with a history of blood loss
Subjects with a history of parathyroidectomy or planned during the study
Subjects with a history of kidney transplant or planned during the study
Abnormal blood pressure, serum magnesium, serum transaminase, serum albumin, platelet counts.
Subjects with a treatment history of similar drugs
Allergic to a drug ingredient or component
Pregnant or nursing women
No birth control during the specified period of time
Subject with a history of alcohol abuse and drug abuse
Participated in clinical trials of other drugs (received experimental drugs)
The investigators determined that other conditions were inappropriate for participation in this clinical trial
Facility Information:
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Trial of SHR6508 in Secondary Hyperparathyroidism
We'll reach out to this number within 24 hrs