A Trial of SHR6508 in Secondary Hyperparathyroidism

Sponsor
Shanghai Hengrui Pharmaceutical Co., Ltd.
Study ID
NCT05221008
Phase
PHASE1
Status
Completed

Conditions

  • Secondary Hyperparathyroidism

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • SHR6508；Placebo — DRUG
    Group A:SHR6508 low dose
  • SHR6508；Placebo — DRUG
    Group B:SHR6508 medium dose
  • SHR6508；Placebo — DRUG
    Group C:SHR6508 high dose
  • SHR6508；Placebo — DRUG
    Group D:SHR6508 high dose(single dose)

Study Details

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

Key Dates

Start date
Mar 10, 2022
Status verified
Jul 2023
Primary completion
Jul 7, 2023
Completion
Aug 2, 2023

Study Design

Enrollment
54 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: group A
    Experimental: SHR6508 Placebo Comparator: normal saline
  • Experimental: group B
    Experimental: SHR6508 Placebo Comparator: normal saline
  • Experimental: group C
    Experimental: SHR6508 Placebo Comparator: normal saline
  • Experimental: group D
    Experimental: SHR6508 Placebo Comparator: normal saline

Primary Outcome Measure

Tmax, Time of maximum observed concentration. [ Time Frame: 0 hour to 43 hours after first dose administration ]

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