New drug FXS5626 put to the test: will it affect the Heart's rhythm?
NCT ID NCT07695779
First seen Jul 10, 2026 · Last updated Jul 10, 2026
Summary
This study investigates the safety and tolerability of a single oral dose of FXS5626 in healthy Chinese adults aged 18 to 45. Researchers will measure how the drug affects the heart's electrical activity (QT interval) and look for any side effects. The goal is to understand the drug's behavior in the body before moving to larger trials.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- FXS5626 tablet
- What this could lead to
- If safe, this could support further studies of FXS5626 for potential future uses.
- What could go wrong
- This is an early Phase 1 trial with only 28 healthy people, so it cannot predict real-world benefits or risks. The drug may cause unexpected side effects or heart rhythm changes.
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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About 28 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- 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 to 45 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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. Healthy, adult, male or female,18-45 years of age (inclusive), with a Body Mass Index (BMI) of 19.0-28.0 kg/m2 (inclusive),have a minimum weight of at least 50kg(male) or 45kg(female). 2. Medically healthy with no clinically significant medical history, physical examination,laboratory profiles, vital signs or ECG abnormalities , as deemed by the PI or designee. 3. Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol. 4. Female subjects of childbearing potential and male subjects with a partner of childbearing potential who voluntarily signed ICF should be no fertile, sperm/egg donation for 3 months from the beginning to the last dose, and voluntary use highly effective contraception (including partner) (non-drug contraception is required during the trial). Exclusive Criteria: 1. Female subjects who are pregnant,or breastfeeding,or with a positive pregnancy test 2. Allergic constitutions (such as allergies to two or more drugs, foods, and pollen), or determined by the investigator, may be allergic to the investigational product or any component of the investigational product. 3. Subjects with a prior or present history of clinically abnormal metabolic, liver, kidney, hematological, pulmonary, cardiovascular, gastrointestinal, urinary, endocrine, neurological, or psychiatric disease who were judged by the investigator to be unsuitable for participation in this study. 4. Subjects who have a history of other risk factors for tachycardia, or a family history of a first-degree relative (i.e. biological parent, sibling, or child) of short QT syndrome, long QT syndrome, or sudden unexplained death in young age (≤40 years). 5. Significant screening ECG abnormalities,QTcF interval \> 450ms (Fridericia's correction), or QRS\>120ms,or PR interval \>=210ms or \<=120ms 6. Subjects who have got severe infections within 2 months before screening; Or have a history of active bacterial infection or viral infection or fungal infection within 2 weeks before screening 7. Subjects virus serological test (hepatitis B virus surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, treponema pallidum specific antibody TPPA) positive results. 8. Subjects with a history of drug abuse,or who screened positive for drug abuse. 9. Subjects who consumed more than 14 units of alcohol per week in the 6 months prior before screening (1 unit of alcohol =360mL beer or 45mL spirits with 40% alcohol or 150mL wine) or had a positive alcohol breath test or could not abstain during the trial. 10. Subjects who smoked more than 5 cigarettes per day in the 6 months prior before screening or could not give up during the trial. 11. Subjects who have abnormal laboratory test: neutrophil count\<1.5 x10\^9/L,or white blood cell count\<3.5 x10\^9/L,or creatine kinase greater than the upper limit of normal at screening.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing Hospital
Beijing, Beijing Municipality, 100730, China