A Mass Balance Study of [14C] SHR6508 in Chinese Hemodialysis Subjects With Secondary Hyperparathyroidism

March 20, 2026 updated by: Shanghai Hengrui Pharmaceutical Co., Ltd.
The study is being conducted to determine the mass balance and routes of excretion of total radioactivity after the dose of [14C] SHR6508.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250014
        • The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Be able and willing to provide a written informed consent form.
  2. Male subjects and postmenopausal women.
  3. Meet the Body Mass Index (BMI) standard.

Exclusion Criteria:

  1. Subjects with a history of cardiovascular diseases.
  2. Subjects with gastrointestinal diseases.
  3. Subjects with a history of surgery.
  4. Subjects with a history of blood loss.
  5. Abnormal blood pressure.
  6. Be allergic to a drug ingredient or component.
  7. Subject with a history of alcohol abuse and drug abuse
  8. The investigators determined that other conditions were inappropriate for participation in this clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: [14C] SHR6508 Injection Group
Drug: [14C] SHR6508 Injection
[14C] SHR6508 injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cumulative excretion of radioactivity
Time Frame: Day 1 to Day 168.
Day 1 to Day 168.
Percentage of parent drug and its metabolites in plasma as a percentage of total radioactive exposure (%AUC)
Time Frame: Day 1 to Day 6.
Day 1 to Day 6.

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse Events (AEs)
Time Frame: About 24 weeks.
About 24 weeks.
Serious adverse Events (SAEs)
Time Frame: About 24 weeks.
About 24 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 23, 2024

Primary Completion (Actual)

April 4, 2025

Study Completion (Actual)

October 11, 2025

Study Registration Dates

First Submitted

March 10, 2025

First Submitted That Met QC Criteria

March 10, 2025

First Posted (Actual)

March 14, 2025

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 20, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR6508-103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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