Evaluation of QTc IntervalPhase 1NCT07695779
QT Interval Effects Study of Oral FXS5626 Tablets
A Phase 1 study testing FXS5626 tablet in people with Evaluation of QTc Interval, run by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the Exposure-Response Relationship Between the Plasma Drug Concentrations and the Change From Baseline in QTc interval of a single oral dose of FXS5626 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Evaluation of QTc Interval
- What is being tested?
- FXS5626 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 13 Aug 2026to 22 Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
- Medically healthy with no clinically significant medical history, physical examination,laboratory profiles, vital signs or ECG abnormalities , as deemed by the PI or designee.
- Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.
- 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:
- Female subjects who are pregnant,or breastfeeding,or with a positive pregnancy test
Show all 16Show fewer
- 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.
- 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.
- 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).
- Significant screening ECG abnormalities,QTcF interval > 450ms (Fridericia's correction), or QRS>120ms,or PR interval >=210ms or <=120ms
- 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
- Subjects virus serological test (hepatitis B virus surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, treponema pallidum specific antibody TPPA) positive results.
- Subjects with a history of drug abuse,or who screened positive for drug abuse.
- 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.
- Subjects who smoked more than 5 cigarettes per day in the 6 months prior before screening or could not give up during the trial.
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Hospital
Beijing, Beijing Municipality, 100730
Qingqing Wang, 86 010-58115037, bjyygcp@vip.126.com
Haijuan Zhao, 86 010-85138673, bjyygcp@vip.126.com
About this study
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
The purpose of this study is to evaluate the Exposure-Response Relationship Between the Plasma Drug Concentrations and the Change From Baseline in QTc interval of a single oral dose of FXS5626 in healthy subjects.
- Conditions
- Evaluation of QTc Interval
- Being tested
- FXS5626 tablet, Placebo tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FXS5626 tabletDrug
FXS5626 75mg、250mg、400mg, single dose, oral
Placebo tabletDrug
single dose, oral
| Study group | Role | What they receive |
|---|---|---|
| FXS5626 | Experimental | FXS5626 75mg、250mg、400mg; single dose, oral Receives: Drug: FXS5626 tablet |
| Placebo | Placebo comparator | single dose, oral Receives: Drug: Placebo tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on QTcF between baseline and post-dose treatment of FXS5626
The Cmax geometric mean corresponds to the upper 90% bilateral confidence interval of ΔΔQTcF
Measured: 45 min before administration and 24 hours after administration
To access the incidence and severity of adverse events (AEs), serious AEs and abnormalities on laboratory tests [Safety and Tolerability] of single ascending oral dose of FXS5626 in healthy adults.
The incidence and severity of adverse events (AEs) , serious AEs and abnormalities on laboratory tests
Measured: Approximately 1 week
Secondary outcomes (1)
Plasma concentration and pharmacokinetic parameters
Cmax
Measured: 10 min before administration and 48 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start13 Aug 2026
- Primary completion21 Sep 2026
- Study completion22 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluation of QTc IntervalStudies of the same condition, open and under way.
- More trials run by Shanghai Fosun Pharmaceutical Industrial Development 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07695779
- Sponsor's protocol ID
- FXS5626-104
- Status last verified
- Oct 2026
- First submitted
- 6 Jul 2026
- Last updated
- 14 Oct 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 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07695779
- Acronym / sponsor ID
- FXS5626-104
- Conditions
- Evaluation of QTc Interval
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Aug 2026 (actual)
- Primary completion
- 21 Sep 2026 (actual)
- Study completion
- 22 Jan 2027 (estimated)
- First posted
- 10 Jul 2026 (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 purpose of this study is to evaluate the Exposure-Response Relationship Between the Plasma Drug Concentrations and the Change From Baseline in QTc interval of a single oral dose of FXS5626 in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FXS5626 | Experimental | Drug: FXS5626 tabletFXS5626 75mg、250mg、400mg; single dose, oral |
| Placebo | Placebo comparator | Drug: Placebo tabletsingle dose, oral |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 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).
- Medically healthy with no clinically significant medical history, physical examination,laboratory profiles, vital signs or ECG abnormalities , as deemed by the PI or designee.
- Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.
- 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).
- Female subjects who are pregnant,or breastfeeding,or with a positive pregnancy test
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| FXS5626 tabletFXS5626 75mg、250mg、400mg, single dose, oral | Drug | FXS5626 |
| Placebo tabletsingle dose, oral | Drug | Placebo |
Primary outcome
Effect on QTcF between baseline and post-dose treatment of FXS5626
Time frame: 45 min before administration and 24 hours after administration
The Cmax geometric mean corresponds to the upper 90% bilateral confidence interval of ΔΔQTcF
To access the incidence and severity of adverse events (AEs), serious AEs and abnormalities on laboratory tests [Safety and Tolerability] of single ascending oral dose of FXS5626 in healthy adults.
Time frame: Approximately 1 week
The incidence and severity of adverse events (AEs) , serious AEs and abnormalities on laboratory tests
1 secondary outcome
Plasma concentration and pharmacokinetic parameters
Time frame: 10 min before administration and 48 hours after administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
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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.
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 FXS5626 tablet in people with Evaluation of QTc Interval, run by Shanghai Fosun Pharmaceutical Industrial Development 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 16 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 14 Oct 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Xue, PHD (86 010-58115037, roserebel@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect on QTcF between baseline and post-dose treatment of FXS5626 (time frame: 45 min before administration and 24 hours after administration). 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 14 Oct 2026.