- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07695779
QT Interval Effects Study of Oral FXS5626 Tablets
6. juli 2026 oppdatert av: Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
28
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Wei Xue, PHD
- Telefonnummer: 86 010-58115037
- E-post: roserebel@126.com
Studer Kontakt Backup
- Navn: Wenyuan Qi
- Telefonnummer: 86 010-85138673
- E-post: qiwenyuan.bjhmoh@gmail.com
Studiesteder
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Kina, 100730
- Beijing Hospital
-
Ta kontakt med:
- Qingqing Wang
- Telefonnummer: 86 010-58115037
- E-post: bjyygcp@vip.126.com
-
Ta kontakt med:
- Haijuan Zhao
- Telefonnummer: 86 010-85138673
- E-post: bjyygcp@vip.126.com
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Ja
Beskrivelse
Inclusion Criteria:
- 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
- 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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: FXS5626
FXS5626 75mg、250mg、400mg; single dose, oral
|
FXS5626 75mg、250mg、400mg, single dose, oral
|
|
Placebo komparator: Placebo
single dose, oral
|
single dose, oral
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Effect on QTcF between baseline and post-dose treatment of FXS5626
Tidsramme: 45 min before administration and 24 hours after administration
|
The Cmax geometric mean corresponds to the upper 90% bilateral confidence interval of ΔΔQTcF
|
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.
Tidsramme: Approximately 1 week
|
The incidence and severity of adverse events (AEs) , serious AEs and abnormalities on laboratory tests
|
Approximately 1 week
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Plasma concentration and pharmacokinetic parameters
Tidsramme: 10 min before administration and 48 hours after administration
|
Cmax
|
10 min before administration and 48 hours after administration
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
5. august 2026
Primær fullføring (Antatt)
25. september 2026
Studiet fullført (Antatt)
25. september 2026
Datoer for studieregistrering
Først innsendt
6. juli 2026
Først innsendt som oppfylte QC-kriteriene
6. juli 2026
Først lagt ut (Faktiske)
10. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
10. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- FXS5626-104
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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