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

Phase 1

Active, not recruiting

• Conditions: Secondary Hyperparathyroidism
• Interventions: Drug: [14C] SHR6508 Injection

• Registration Number: NCT06877247
• Lead Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Brief Summary

The study is being conducted to determine the mass balance and routes of excretion of total radioactivity after the dose of \[14C\] SHR6508.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-19
• Study First Submitted: 2025-03-10
• Study First Submitted QC: 2025-03-10
• Study First Posted: 2025-03-14
• Status Verified: 2025-04
• Primary Completion: 2025-04-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-17
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[14C] SHR6508 Injection Group	[14C] SHR6508 Injection	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Adverse Events (AEs)	About 24 weeks.
Serious adverse Events (SAEs)	About 24 weeks.

Trial Locations

Locations (1)

The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province); 🇨🇳 Jinan, Shandong, China