Hemodialysis Subjects With Secondary HyperparathyroidismPhase 1NCT07284043
A Mass Balance Study of [14C] MT1013 in Hemodialysis Subjects With Secondary Hyperparathyroidism
A Phase 1 study testing [14C] MT1013/MT1013 Injection in people with Hemodialysis Subjects With Secondary Hyperparathyroidism, run by Shaanxi Micot Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
MT1013 is a first-in-class dual-target agonist.This study is being conducted to determine the mass balance and routes of excretion of total radioactivity after the dose of [14C] MT1013. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis Subjects With Secondary Hyperparathyroidism
- What is being tested?
- [14C] MT1013/MT1013 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 27 Nov 2025to 14 May 2026
- 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
- 1. Male or postmenopausal female participants, aged 18 years or older, with a confirmed diagnosis of SHPT.
- 2. The BMI is between 18 kg/m2 and 35 kg/m2;
- 3. The subjects must undergo regular maintenance hemodialysis three times a week for at least three months；
- 4. Within 14 days prior to randomization, subjects must have serum calcium levels≥ 8.4 mg/dL;
- 5.Subject capable of understanding written information ,willing to participate in, and provide a written informed consent;
Who cannot join
- 1. The subjects underwent parathyroidectomy within 6 months prior to screening, or plan to undergo parathyroidectomy or ablation or radiation during the study;
- 2. Gastrointestinal bleeding or peptic ulcer medical history within 6 months prior to screening;
- 3. The subjects had myocardial infarction or had undergone coronary angioplasty or coronary artery bypass grafting within 6 months before screening.
- 4．Subjects with severe uncontrolled hypertension, defined as systolic blood pressure>180 mmHg and/or diastolic blood pressure>110 mmHg;
- 5. History of epileptic seizures or ongoing epilepsy related treatment within 1 year prior to screening;
- 6. History of malignant tumors within the five years prior to screening;
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- 7. The subjects received oral cinacalcet or ivocalcet within 7 days before signing the informed consent form, or received Etelcalcetide injection treatment within 4 months.
- 8. Engaged in work that requires long-term exposure to radioactive conditions; Or those who have had significant radioactive exposure or participated in radioactive drug labeling tests within one year prior to screening;
- 9. Participants who may not be able to complete this study for other reasons or who the researchers consider should not be included.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital)
Jinan, Shandong, 250014
About this study
MT1013 is a first-in-class dual-target agonist.This study is being conducted to determine the mass balance and routes of excretion of total radioactivity after the dose of [14C] MT1013.
- Being tested
- [14C] MT1013/MT1013 Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C] MT1013/MT1013 InjectionDrug
[14C] MT1013/MT1013 Injection
| Study group | Role | What they receive |
|---|---|---|
| [14C] MT1013/MT1013 Injection Group | Experimental | Not described Receives: Drug: [14C] MT1013/MT1013 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 91.
Percentage of parent drug and its metabolites in plasma as a percentage of total radioactive exposure (%AUC)
Measured: Day 1 to Day 91.
Secondary outcomes (2)
Adverse Events (AEs)
Measured: About 13 weeks.
Serious adverse Events (SAEs)
Measured: About 13 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start27 Nov 2025
- Primary completion14 May 2026
- Study completion14 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis Subjects With Secondary HyperparathyroidismStudies of the same condition, open and under way.
- 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaanxi Micot Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07284043
- Sponsor's protocol ID
- MT1013-I-C03
- Status last verified
- Dec 2025
- First submitted
- 23 Nov 2025
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mass Balance Study of [14C] MT1013 in Hemodialysis Subjects With Secondary Hyperparathyroidism
- ClinicalTrials.gov ID
- NCT07284043
- Acronym / sponsor ID
- MT1013-I-C03
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Shaanxi Micot Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Nov 2025 (actual)
- Primary completion
- 14 May 2026 (actual)
- Study completion
- 14 May 2026 (actual)
- First posted
- 16 Dec 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.
MT1013 is a first-in-class dual-target agonist.This study is being conducted to determine the mass balance and routes of excretion of total radioactivity after the dose of [14C] MT1013.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C] MT1013/MT1013 Injection Group | Experimental | Drug: [14C] MT1013/MT1013 Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. Male or postmenopausal female participants, aged 18 years or older, with a confirmed diagnosis of SHPT.
- 2. The BMI is between 18 kg/m2 and 35 kg/m2;
- 3. The subjects must undergo regular maintenance hemodialysis three times a week for at least three months；
- 4. Within 14 days prior to randomization, subjects must have serum calcium levels≥ 8.4 mg/dL;
- 5.Subject capable of understanding written information ,willing to participate in, and provide a written informed consent;
Key exclusion criteria (9 listed)
- 1. The subjects underwent parathyroidectomy within 6 months prior to screening, or plan to undergo parathyroidectomy or ablation or radiation during the study;
- 2. Gastrointestinal bleeding or peptic ulcer medical history within 6 months prior to screening;
- 3. The subjects had myocardial infarction or had undergone coronary angioplasty or coronary artery bypass grafting within 6 months before screening.
- 4．Subjects with severe uncontrolled hypertension, defined as systolic blood pressure>180 mmHg and/or diastolic blood pressure>110 mmHg;
- 5. History of epileptic seizures or ongoing epilepsy related treatment within 1 year prior to screening;
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] MT1013/MT1013 Injection[14C] MT1013/MT1013 Injection | Drug | [14C] MT1013/MT1013 Injection Group |
Primary outcome
Cumulative excretion of radioactivity
Time frame: Day 1 to Day 91.
Percentage of parent drug and its metabolites in plasma as a percentage of total radioactive exposure (%AUC)
Time frame: Day 1 to Day 91.
2 secondary outcomes
Adverse Events (AEs)
Time frame: About 13 weeks.
Serious adverse Events (SAEs)
Time frame: About 13 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 24 Jul 2026.
Related trials for Hemodialysis Subjects With Secondary Hyperparathyroidism
RecruitingPhase 3
A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
Secondary Hyperparathyroidism, Chronic Kidney Disease
RecruitingPhase 2
Study of MT1013 Injection for the Treatment of Secondary Hyperparathyroidism (SHPT) Patients With Chronic Kidney Disease Undergoing Maintenance Dialysis
Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis
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] MT1013/MT1013 Injection in people with Hemodialysis Subjects With Secondary Hyperparathyroidism, run by Shaanxi Micot Pharmaceutical Technology 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 5 inclusion and 9 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 24 Jul 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 91.). 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 24 Jul 2026.