Tiny trial tracks new Drug's journey in dialysis patients
NCT ID NCT07284043
First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 1 time
Summary
This early-stage study looks at how the experimental drug MT1013 moves through and leaves the body of people on hemodialysis who have secondary hyperparathyroidism. Six participants will receive a single dose, and researchers will measure radioactivity in blood, urine, and stool to track the drug. The goal is not to treat the disease but to understand the drug's breakdown and elimination, which is a necessary step before larger safety and effectiveness trials can begin.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- MT1013 (a dual-target agonist drug)
- What this could lead to
- If successful, this study will clarify how MT1013 is absorbed and eliminated, which is essential for future dosing and safety studies.
- What could go wrong
- This is a very early Phase 1 trial with only 6 participants, so results may not apply broadly. The drug is still experimental and may not prove effective or safe in larger trials.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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6 people
The number who actually took part.
- Started
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Nov 2025
- Finished
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May 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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; Exclusion Criteria: * 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; * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital)
Jinan, Shandong, 250014, China