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

Hengrui Medicine

Status and phase: Active, not recruiting; Phase 1

Conditions: Secondary Hyperparathyroidism

Treatments: Drug: [14C] SHR6508 Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06877247

SHR6508-103

Details and patient eligibility

About

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

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

[14C] SHR6508 Injection Group

Experimental group

Treatment:

Drug: [14C] SHR6508 Injection