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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06877247

Enrollment

Registered

2025-03-14

Start date

2024-12-23

Completion date

2025-10-11

Last updated

2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Secondary Hyperparathyroidism

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.

Interventions

DRUG[14C] SHR6508 Injection

\[14C\] SHR6508 injection.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Adverse Events (AEs)	About 24 weeks.
Serious adverse Events (SAEs)	About 24 weeks.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026