- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07712393
A Comparative Study to Investigate the Difference in Blood Levels of Two Different Formulations of GSK5784283
28. juli 2026 oppdatert av: GlaxoSmithKline
Open-Label, Randomized, Single Dose, Parallel Group, Phase 1 Study in Healthy Volunteers to Evaluate the Relative Bioavailability of Two Formulations of GSK5784283 Administered by Subcutaneous Injection
The purpose of this study is to compare how two different formulations of the study medicine (GSK5784283) move through the body over time (pharmacokinetic [PK] study) in healthy adults.
The aim of the study is to see how the body processes GSK5784283 and determine if the study medicine is safe, how well it is tolerated by the body and if the study medicines being tested work in the body in the same way.
Studieoversikt
Studietype
Intervensjonell
Registrering (Antatt)
24
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: US GSK Clinical Trials Call Center
- Telefonnummer: 877-379-3718
- E-post: GSKClinicalSupportHD@gsk.com
Studer Kontakt Backup
- Navn: EU GSK Clinical Trials Call Center
- Telefonnummer: +44 (0) 20 89904466
- E-post: GSKClinicalSupportHD@gsk.com
Studiesteder
-
-
Texas
-
Austin, Texas, Forente stater, 78744
- Rekruttering
- GSK Investigational Site
-
Ta kontakt med:
- US GSK Clinical Trials Call Center
- Telefonnummer: 877-379-3718
- E-post: GSKClinicalSupportHD@gsk.com
-
Ta kontakt med:
- EU GSK Clinical Trials Call Centre
- Telefonnummer: +44 (0) 20 8990 4466
- E-post: GSKClinicalSupportHD@gsk.com
-
Hovedetterforsker:
- Sean Gilbey
-
-
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:
- Participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECG.
- Body weight greater than or equal (>=) 50 kilogram (kg) (110 pounds [lbs]) and body mass index within the range 19 to 30 kilogram per meter square (kg/m^2) (inclusive).
- A female participant is eligible to participate if she is a participant of non-childbearing potential (PONCBP) as specified in the protocol.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Exclusion Criteria:
- Hypersensitivity- Participants with allergy/intolerance to any biologic therapy or any of the known excipients used in products administered subcutaneously
- History or presence of any clinically significant medical condition capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.
- Any clinically relevant abnormal findings in physical examination, hematology, clinical chemistry, urinalysis, vital signs during screening period which in the opinion of the investigator, may put the subject at risk because of his/her participation in the study, or may influence the results of the study, or the subject's ability to participate in the study.
- Live vaccine(s) within 1 month prior to screening or plans to receive such vaccines during the clinical study.
- Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to study intervention administration.
- Current smokers (tobacco and/or marijuana) or former smokers with a smoking history >10 pack-years and participants using vaping products, including electronic cigarettes.
- Regular alcohol consumption that exceeds the limits specified in the protocol
- Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the clinical study.
- The QTc is the QT interval corrected for heart rate according to Fridericia's formula (QTcF), machine-read or manually over-read >450 millisecond (msec).
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: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: GSK5784283 Test Formulation
|
GSK5784283 vil bli administrert.
|
|
Eksperimentell: GSK5784283 Reference Formulation
|
GSK5784283 vil bli administrert.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Maximum Observed Concentration (Cmax) of GSK5784283 Serum Samples
Tidsramme: Pre-dose and up to 253 days post dose
|
Pre-dose and up to 253 days post dose
|
|
Area Under the Curve from Zero up to 253 Days [AUC(0-253 d)] of GSK5784283 Serum Samples
Tidsramme: Pre-dose and up to 253 days post dose
|
Pre-dose and up to 253 days post dose
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs), Serious AEs and Adverse Event of Special Interest (AESI)
Tidsramme: Up to 253 days
|
Up to 253 days
|
|
Number of Participants with Clinically Significant Change from Baseline in Laboratory Assessments, Vital Signs and Electrocardiogram (ECG) Values
Tidsramme: Baseline and up to 253 days
|
Baseline and up to 253 days
|
|
Proportion of Participants with Anti-drug Antibody (ADA) Incidence, ADA Titre Assessment and Neutralizing Antibody (NAb) Incidence Against GSK5784283
Tidsramme: Up to 253 days
|
Up to 253 days
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: GSK Clinical Trials, GlaxoSmithKline
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 (Faktiske)
17. juli 2026
Primær fullføring (Antatt)
13. april 2027
Studiet fullført (Antatt)
26. april 2027
Datoer for studieregistrering
Først innsendt
14. juli 2026
Først innsendt som oppfylte QC-kriteriene
14. juli 2026
Først lagt ut (Faktiske)
17. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
29. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
28. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 307918
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents.
Data sharing is subject to certain criteria, conditions, and exceptions.
For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
IPD-delingstidsramme
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
Tilgangskriterier for IPD-deling
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place.
Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .