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A Trial of SHR6508 in Secondary Hyperparathyroidism

NCT05221008 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2023-08-08

No results posted yet for this 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

Conditions

  • Secondary Hyperparathyroidism

Interventions

DRUG

SHR6508；Placebo

Group A:SHR6508 low dose

DRUG

SHR6508；Placebo

Group B:SHR6508 medium dose

DRUG

SHR6508；Placebo

Group C:SHR6508 high dose

DRUG

SHR6508；Placebo

Group D:SHR6508 high dose(single dose)

Sponsors & Collaborators

  • Shanghai Hengrui Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-10
Primary Completion
2023-07-07
Completion
2023-08-02

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05221008 on ClinicalTrials.gov