A Trial of SHR6508 in Secondary Hyperparathyroidism

NCT05221008 | Completed Phase 1

• 1 other identifier: SHR6508-102
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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

Conditions

Secondary Hyperparathyroidism

Outcome Measures

Primary Outcomes (21)

• Tmax, Time of maximum observed concentration.

  0 hour to 43 hours after first dose administration

• Cmax, Maximum observed concentration.

  0 hour to 43 hours after first dose administration

• AUC0-t, Area under the concentration-time curve from time zero to the last measurable concentration.

  0 hour to 43 hours after first dose administration

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

  0 hour to 43 hours after first dose administration

• t1/2z, Terminal elimination half-life

  0 hour to 43 hours after first dose administration

• CLz, Total Body Clearance

  0 hour to 43 hours after first dose administration

• Vz, Volume of distribution based on the terminal phase

  0 hour to 43 hours after first dose administration

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

  0 hour to 43 hours after first dose administration

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

  0 hour to 43 hours after first dose administration

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

  Day1-Day29(if reach steady-state)

• Cmin,ss : Minimum observed concentration at steady-state

  Day1-Day29(if reach steady-state)

• Cav : Average concentration

  Day1-Day29(if reach steady-state)

• AUC0-t,ss, Area under the concentration-time curve from time zero to the last measurable concentration at steady-state.

  Day1-Day29(if reach steady-state)

• AUC0-∞,ss, Area under the concentration-time curve from time 0 extrapolated to infinite time at steady-state.

  Day1-Day29(if reach steady-state)

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

  Day1-Day29(if reach steady-state)

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

  Day1-Day29(if reach steady-state)

• CLss, Total Body Clearance at steady-state.

  Day1-Day29(if reach steady-state)

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

  Day1-Day29(if reach steady-state)

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

  Day1-Day29(if reach steady-state)

• DF: Degree of Fluctuation

  Day1-Day29(if reach steady-state)

• Accumulation Ratio

  Day1-Day29(if reach steady-state)

Secondary Outcomes (5)

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

  0 hour to 43 hours after first dose administration

• Change From Baseline to End of Study in serum iPTH, cCa, P, FGF23 and BSAP

  Day1 to Day29

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

  Day1 to Day29

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

  Day1 to Day29

• Participants With Treatment-Emergent Adverse Events (TEAEs)

  Day1 to End of Study, End of Study is about Day55

Study Arms (4)

group A

EXPERIMENTAL

Experimental: SHR6508 Placebo Comparator: normal saline

Drug: SHR6508；Placebo

group B

EXPERIMENTAL

Experimental: SHR6508 Placebo Comparator: normal saline

Drug: SHR6508；Placebo

group C

EXPERIMENTAL

Experimental: SHR6508 Placebo Comparator: normal saline

Drug: SHR6508；Placebo

group D

EXPERIMENTAL

Experimental: SHR6508 Placebo Comparator: normal saline

Drug: SHR6508；Placebo

Interventions

SHR6508；Placebo DRUG

Group A:SHR6508 low dose

group A

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Shanghai Hengrui Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Hyperparathyroidism, Secondary

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SHR6508 compared with placebo

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: February 2, 2022
• Study Start: March 10, 2022
• Primary Completion: July 7, 2023
• Study Completion: August 2, 2023
• Last Updated: August 8, 2023

Record last verified: 2023-07

Locations

CN (1)