Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
54 participants
INTERVENTIONAL
2022-03-10
2023-08-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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group A
Experimental: SHR6508 Placebo Comparator: normal saline
SHR6508；Placebo
Group A:SHR6508 low dose
group B
Experimental: SHR6508 Placebo Comparator: normal saline
SHR6508；Placebo
Group B:SHR6508 medium dose
group C
Experimental: SHR6508 Placebo Comparator: normal saline
SHR6508；Placebo
Group C:SHR6508 high dose
group D
Experimental: SHR6508 Placebo Comparator: normal saline
SHR6508；Placebo
Group D:SHR6508 high dose(single dose)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
70 Years
ALL
No
Sponsors
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Shanghai Hengrui Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Countries
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Other Identifiers
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SHR6508-102
Identifier Type: -
Identifier Source: org_study_id
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