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CompletedNCT05221008Updated Aug 8, 2023

A Trial of SHR6508 in Secondary Hyperparathyroidism

A Phase 1 interventional study of SHR6508；Placebo and SHR6508；Placebo in Secondary Hyperparathyroidism, sponsored by Shanghai Hengrui Pharmaceutical Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-08-08.

Sponsored by Shanghai Hengrui Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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

02

Conditions studied

  • Secondary Hyperparathyroidism
03

In context

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.

This study's enrollment of 54 is close to the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd. is the lead sponsor of 59 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
54 participants (actual)

Study arms

  • Experimental
    group A

    Experimental: SHR6508 Placebo Comparator: normal saline

    Drug: SHR6508；Placebo

  • Experimental
    group B

    Experimental: SHR6508 Placebo Comparator: normal saline

    Drug: SHR6508；Placebo

  • Experimental
    group C

    Experimental: SHR6508 Placebo Comparator: normal saline

    Drug: SHR6508；Placebo

  • Experimental
    group D

    Experimental: SHR6508 Placebo Comparator: normal saline

    Drug: SHR6508；Placebo

Interventions

  • DrugSHR6508；Placebo

    Group A:SHR6508 low dose

  • DrugSHR6508；Placebo

    Group B:SHR6508 medium dose

  • DrugSHR6508；Placebo

    Group C:SHR6508 high dose

  • DrugSHR6508；Placebo

    Group D:SHR6508 high dose(single dose)

06

What researchers measure

Primary outcomes

  1. Tmax, Time of maximum observed concentration.

    Time frame: 0 hour to 43 hours after first dose administration

  2. Cmax, Maximum observed concentration.

    Time frame: 0 hour to 43 hours after first dose administration

  3. 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

  4. AUC0-∞, Area under the curve from time 0 extrapolated to infinite time

    Time frame: 0 hour to 43 hours after first dose administration

  5. t1/2z, Terminal elimination half-life

    Time frame: 0 hour to 43 hours after first dose administration

  6. CLz, Total Body Clearance

    Time frame: 0 hour to 43 hours after first dose administration

  7. Vz, Volume of distribution based on the terminal phase

    Time frame: 0 hour to 43 hours after first dose administration

  8. MRT0-t, Mean residence time from time zero to the last measurable concentration.

    Time frame: 0 hour to 43 hours after first dose administration

  9. MRT0-∞, Mean residence time from time 0 extrapolated to infinite time

    Time frame: 0 hour to 43 hours after first dose administration

  10. Cmax,ss : Maximum observed concentration at steady-state.

    Time frame: Day1-Day29(if reach steady-state)

  11. Cmin,ss : Minimum observed concentration at steady-state

    Time frame: Day1-Day29(if reach steady-state)

  12. Cav : Average concentration

    Time frame: Day1-Day29(if reach steady-state)

  13. 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)

  14. 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)

  15. Tmax,ss, Time of maximum observed concentration at steady-state.

    Time frame: Day1-Day29(if reach steady-state)

  16. t1/2z,ss, Terminal elimination half-life at steady-state

    Time frame: Day1-Day29(if reach steady-state)

  17. CLss, Total Body Clearance at steady-state.

    Time frame: Day1-Day29(if reach steady-state)

  18. Vss, Volume of distribution based on the terminal phase at steady-state.

    Time frame: Day1-Day29(if reach steady-state)

  19. MRT0-∞, Mean residence time from time 0 extrapolated to infinite time.

    Time frame: Day1-Day29(if reach steady-state)

  20. DF: Degree of Fluctuation

    Time frame: Day1-Day29(if reach steady-state)

  21. Accumulation Ratio

    Time frame: Day1-Day29(if reach steady-state)

Secondary outcomes

  1. Change From Baseline in serum iPTH, cCa, P, FGF23 and BSAP

    iPTH, FGF23 and BSAP were tested at a central laboratory.

    Time frame: 0 hour to 43 hours after first dose administration

  2. 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.

    Time frame: Day1 to Day29

  3. Proportion of Participants to End of Study whose iPTH decreased by≥30% from baseline

    iPTH was tested at a central laboratory.

    Time frame: Day1 to Day29

  4. Proportion of Participants to End of Study whose iPTH decreased to 300 pg/mL from baseline

    iPTH was tested at a central laboratory

    Time frame: Day1 to Day29

  5. Participants With Treatment-Emergent Adverse Events (TEAEs)

    Terms were coded with Medical Dictionary for Regulatory Activities (MedDRA)

    Time frame: Day1 to End of Study, End of Study is about Day55

07

Study locations

1 site
  • Guangdong Provincial People's Hospital
    Guangzhou, Guangdong, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05221008
Lead sponsor
Shanghai Hengrui Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Feb 2, 2022
Start date
Mar 10, 2022
Primary completion
Jul 7, 2023
Completion
Aug 2, 2023
Last update
Aug 8, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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