A Trial of SHR6508 in Secondary Hyperparathyroidism

Hengrui Medicine

Status and phase: Completed; Phase 1

Conditions: Secondary Hyperparathyroidism

Treatments: Drug: SHR6508；Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05221008

SHR6508-102

Details and patient eligibility

About

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

Enrollment: 54 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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54 participants in 4 patient groups

group A

Experimental group

Description:

Experimental: SHR6508 Placebo Comparator: normal saline

Treatment:

Drug: SHR6508；Placebo

Drug: SHR6508；Placebo

Drug: SHR6508；Placebo

Drug: SHR6508；Placebo

group B

Experimental group

Description:

Experimental: SHR6508 Placebo Comparator: normal saline

Treatment:

Drug: SHR6508；Placebo

Drug: SHR6508；Placebo

Drug: SHR6508；Placebo

Drug: SHR6508；Placebo

group C

Experimental group

Description:

Experimental: SHR6508 Placebo Comparator: normal saline

Treatment:

Drug: SHR6508；Placebo

Drug: SHR6508；Placebo

Drug: SHR6508；Placebo

Drug: SHR6508；Placebo

group D

Experimental group

Description:

Experimental: SHR6508 Placebo Comparator: normal saline

Treatment:

Drug: SHR6508；Placebo

Drug: SHR6508；Placebo

Drug: SHR6508；Placebo

Drug: SHR6508；Placebo