A Trial of SHR6508 in Secondary Hyperparathyroidism

• Status: Not yet recruiting
• Trial end date: 2022-09-30
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Criteria

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