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

NCT ID: NCT06877247

Last Updated: 2025-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-19

Study Completion Date

2025-09-30

Brief Summary

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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

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Conditions

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Secondary Hyperparathyroidism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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[14C] SHR6508 Injection Group

Group Type EXPERIMENTAL

[14C] SHR6508 Injection

Intervention Type DRUG

\[14C\] SHR6508 injection.

Interventions

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[14C] SHR6508 Injection

\[14C\] SHR6508 injection.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Hengrui Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province)

Jinan, Shandong, China

Site Status

Countries

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China

Other Identifiers

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SHR6508-103

Identifier Type: -

Identifier Source: org_study_id

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