QT Interval Effects of FXS5626 Tablets in Healthy Adults
Official title: A Single-Center, Double-Blind, Placebo-Controlled, Dose-Escalating Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and QT Interval Effects of Oral FXS5626 Tablets in Healthy Chinese Participants
Run by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. · NCT07695779 · Data updated 2026-11-12
This study tests whether a single dose of FXS5626 affects the heart’s QT interval in healthy adults compared to placebo.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Enrollment | 28 (estimated) |
| Sponsor | Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. Industry-sponsored |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | August 13, 2026 |
| Main results expected | September 21, 2026 |
| Study ends | January 22, 2027 |
| Registry record updated | October 14, 2026 |
| Trial ID | NCT07695779 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults aged 18-45 with BMI 19.0-28.0 kg/m2 and no significant medical history.
✕Probably not a fit
Individuals with pregnancy or breastfeeding, significant medical conditions, or contraindications to study procedures may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1 study examines the relationship between plasma levels of a single oral dose of FXS5626 and changes in QTc interval in healthy volunteers. Participants receive either FXS5626 or a placebo in a controlled setting, with ECGs and blood samples collected to characterize exposure and cardiac response. The trial uses standard safety monitoring and strict eligibility to ensure healthy volunteers without significant medical histories. Results may inform dose selection and safety profiling for future studies. The study is conducted at Beijing Hospital with Shanghai Fosun Pharmaceutical as the lead sponsor.
Why it matters
Potential benefit: If successful, the study could help determine a safe dosing range and improve understanding of cardiac safety for FXS5626.
How similar studies have gone: Cardiac safety studies of new compounds in healthy volunteers have been used to characterize QT effects in prior research, though this exact compound is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Beijing Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Wei Xue, PHD
- Email: roserebel@126.com
- Phone: 86 010-58115037
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.