NCT06877247

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 23, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 14, 2025

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2025

Completed
Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

March 10, 2025

Last Update Submit

March 20, 2026

Conditions

Secondary Hyperparathyroidism

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Adverse Events (AEs)

    About 24 weeks.

  • Serious adverse Events (SAEs)

    About 24 weeks.

Study Arms (1)

[14C] SHR6508 Injection Group

EXPERIMENTAL
Drug: [14C] SHR6508 Injection

Interventions

[14C] SHR6508 InjectionDRUG

\[14C\] SHR6508 injection.

[14C] SHR6508 Injection Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Jinan, Shandong, 250014, China

Location

MeSH Terms

Conditions

Hyperparathyroidism, Secondary

Condition Hierarchy (Ancestors)

HyperparathyroidismParathyroid DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2025

First Posted

March 14, 2025

Study Start

December 23, 2024

Primary Completion

April 4, 2025

Study Completion

October 11, 2025

Last Updated

March 23, 2026

Record last verified: 2026-03

Locations

CN(1)