Secondary HyperparathyroidismPhase 1NCT06877247
A Mass Balance Study of [14C] SHR6508 in Chinese Hemodialysis Subjects With Secondary Hyperparathyroidism
A Phase 1 study testing [14C] SHR6508 Injection in people with Secondary Hyperparathyroidism, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to determine the mass balance and routes of excretion of total radioactivity after the dose of [14C] SHR6508. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary Hyperparathyroidism
- What is being tested?
- [14C] SHR6508 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- 23 Dec 2024to 11 Oct 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be able and willing to provide a written informed consent form.
- Male subjects and postmenopausal women.
- Meet the Body Mass Index (BMI) standard.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province)
Jinan, Shandong, 250014
About this study
The study is being conducted to determine the mass balance and routes of excretion of total radioactivity after the dose of [14C] SHR6508.
- Conditions
- Secondary Hyperparathyroidism
- Being tested
- [14C] SHR6508 Injection
- Medical subject headings
- Hyperparathyroidism, Secondary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C] SHR6508 InjectionDrug
[14C] SHR6508 injection.
| Study group | Role | What they receive |
|---|---|---|
| [14C] SHR6508 Injection Group | Experimental | Not described Receives: Drug: [14C] SHR6508 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative excretion of radioactivity
Measured: Day 1 to Day 168.
Percentage of parent drug and its metabolites in plasma as a percentage of total radioactive exposure (%AUC)
Measured: Day 1 to Day 6.
Secondary outcomes (2)
Adverse Events (AEs)
Measured: About 24 weeks.
Serious adverse Events (SAEs)
Measured: About 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start23 Dec 2024
- Primary completion4 Apr 2025
- Study completion11 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary HyperparathyroidismStudies of the same condition, open and under way.
- More trials run by Shanghai Hengrui Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06877247
- Sponsor's protocol ID
- SHR6508-103
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2025
- Last updated
- 23 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mass Balance Study of [14C] SHR6508 in Chinese Hemodialysis Subjects With Secondary Hyperparathyroidism
- ClinicalTrials.gov ID
- NCT06877247
- Acronym / sponsor ID
- SHR6508-103
- Conditions
- Secondary Hyperparathyroidism
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Dec 2024 (actual)
- Primary completion
- 4 Apr 2025 (actual)
- Study completion
- 11 Oct 2025 (actual)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is being conducted to determine the mass balance and routes of excretion of total radioactivity after the dose of [14C] SHR6508.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C] SHR6508 Injection Group | Experimental | Drug: [14C] SHR6508 Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be able and willing to provide a written informed consent form.
- Male subjects and postmenopausal women.
- Meet the Body Mass Index (BMI) standard.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [14C] SHR6508 Injection[14C] SHR6508 injection. | Drug | [14C] SHR6508 Injection Group |
Primary outcome
Cumulative excretion of radioactivity
Time frame: Day 1 to Day 168.
Percentage of parent drug and its metabolites in plasma as a percentage of total radioactive exposure (%AUC)
Time frame: Day 1 to Day 6.
2 secondary outcomes
Adverse Events (AEs)
Time frame: About 24 weeks.
Serious adverse Events (SAEs)
Time frame: About 24 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C] SHR6508 Injection in people with Secondary Hyperparathyroidism, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative excretion of radioactivity (time frame: Day 1 to Day 168.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.