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Relative Bioavailability, Safety, and Tolerability of Single-dose Sotrovimab Injection in Adults (COSMIC) (COSMIC)

2. november 2022 opdateret af: Vir Biotechnology, Inc.

A Phase 1, Open-label, Randomized, Parallel Group, Single-dose Clinical Pharmacology Study to Investigate the Relative Bioavailability, Safety, and Tolerability of Two Different Concentrations of Sotrovimab Administered at Different Injection Sites, in Male or Female Healthy Participants Aged 18 to 65 Years

This clinical pharmacology study will evaluate the relative bioavailability, safety, and tolerability of two different concentrations of sotrovimab injections administered at different injection sites in male or female healthy participants aged 18 to 65 years. The study will be conducted in three parts (Part A, an optional Part B and Part C).

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

504

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • California
      • Riverside, California, Forenede Stater, 92503
        • Rekruttering
        • Investigative Site
    • Florida
      • Atlantis, Florida, Forenede Stater, 33462
        • Rekruttering
        • Investigative Site
      • Edgewater, Florida, Forenede Stater, 32132
        • Rekruttering
        • Investigative Site
        • Kontakt:
          • Study Inquiry
    • Missouri
      • Saint Louis, Missouri, Forenede Stater, 63141
        • Rekruttering
        • Investigative Site
    • New York
      • Binghamton, New York, Forenede Stater, 13901
        • Rekruttering
        • Investigative Site
    • Oklahoma
      • Yukon, Oklahoma, Forenede Stater, 73099
        • Rekruttering
        • Investigative Site
    • Oregon
      • Medford, Oregon, Forenede Stater, 97504
        • Rekruttering
        • Investigative Site
        • Kontakt:
          • Study Inquiry
    • Texas
      • Austin, Texas, Forenede Stater, 78745
        • Rekruttering
        • Investigative Site
      • Houston, Texas, Forenede Stater, 77065
        • Rekruttering
        • Investigative Site
    • Utah
      • West Jordan, Utah, Forenede Stater, 84088
        • Rekruttering
        • Investigative Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Male or female participants, aged 18 to 65 years, inclusive.
  • Participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
  • For Part C, inclusion in the Japanese subgroup analysis, a participant must meet all of the following criteria: Japanese ancestry, defined as being a descendant of 4 ethnic Japanese grandparents and 2 ethnic Japanese parents.
  • Body Mass Index (BMI) within the range of 18 to 30 kilogram per square meter (kg/m^2).
  • Capable of giving signed informed consent

Exclusion Criteria:

  • History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
  • Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
  • Breast cancer within the past 10 years
  • Abnormal blood pressure at Screening.
  • Known hypersensitivity to any constituent present in the investigational product or history of severe hypersensitivity or anaphylaxis after receiving a COVID-19 vaccine
  • Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions
  • Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • Use of any over the counter or prescription medications unless permitted by the protocol or approved by the Investigator in conjunction with the GSK medical monitor.
  • For Part A and Part B, any condition that would prohibit receipt of injections in the investigator's opinion, such as coagulation disorder, bleeding diathesis, or thrombocytopenia.
  • Treatment with biologic agents (such as) within 3 months or 5 half-lives
  • Receipt of convalescent plasma from a recovered COVID-19 participant or anti- severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) monoclonal antibody (mAb) within the last 3 months.
  • Receipt of any vaccine within 48 hours prior to enrollment.
  • Has received a SARS-CoV-2 vaccine but has not completed all doses in the series more than 28 days prior to Screening.
  • Exposure to more than 4 new chemical entities (e.g., investigational pharmaceuticals) within 12 months prior to the first dosing day.
  • Enrolment in any investigational vaccine study within the last 180 days or enrollment in any other investigational drug study within 30 days prior to Day 1 or within 5 half-lives
  • Current enrolment or past participation in this clinical study.
  • A positive pre-study hepatitis B surface antigen or positive hepatitis C antibody test result at Screening or within 3 months prior to dosing.
  • Positive pre-study drug/alcohol screen.
  • Positive human immunodeficiency virus (HIV) antibody test.
  • History of regular alcohol consumption within 6 months prior to the study.
  • Regular use of known drugs of abuse.
  • 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 study.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Part A Cohort 1: Concentration 1 of sotrovimab
administered at injection site 1
Biologisk: sotrovimab
via IM injection
Biologisk: sotrovimab
via IV infusion
Eksperimentel: Part A Cohort 2: Concentration 2 of sotrovimab
administered at injection site 1
Biologisk: sotrovimab
via IM injection
Biologisk: sotrovimab
via IV infusion
Eksperimentel: Part A Cohort 3: Concentration 2 of sotrovimab
administered at injection site 2
Biologisk: sotrovimab
via IM injection
Biologisk: sotrovimab
via IV infusion
Eksperimentel: Part A Cohort 4: Concentration 2 of sotrovimab
administered at injection site 3
Biologisk: sotrovimab
via IM injection
Biologisk: sotrovimab
via IV infusion
Eksperimentel: Part B Cohort 5: Concentration 1 of sotrovimab
administered at potential injection site 1,2,3 or other
Biologisk: sotrovimab
via IM injection
Biologisk: sotrovimab
via IV infusion
Eksperimentel: Part B Cohort 6: Concentration 2 of sotrovimab
administered at potential injection site 1,2,3 or other
Biologisk: sotrovimab
via IM injection
Biologisk: sotrovimab
via IV infusion
Eksperimentel: Part C Cohort 7: Concentration 2 of sotrovimab
administered by intravenous (IV) infusion
Biologisk: sotrovimab
via IM injection
Biologisk: sotrovimab
via IV infusion
Eksperimentel: Part C Cohort 8: Concentration 2 of sotrovimab
administered by IV infusion
Biologisk: sotrovimab
via IM injection
Biologisk: sotrovimab
via IV infusion

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Part A (Cohort 1, 2): Area under the serum concentration-time curve (AUC) from Day 1 to Day 29 (AUC D1-29) following administration of sotrovimab
Tidsramme: Up to Day 29
Up to Day 29
Part A (Cohort 1, 2): Maximum observed concentration (Cmax) following administration of sotrovimab through Day 29
Tidsramme: Up to Day 29
Up to Day 29
Part A (Cohort 1, 2): Number of participants with adverse events (AEs), serious adverse events (SAEs), and AEs of special interest (AESI) through Day 29
Tidsramme: Up to Day 29
Up to Day 29
Part C (Cohort 7, 8): Number of participants with AEs, SAEs, and AESI
Tidsramme: Up to Day 29
Up to Day 29

Sekundære resultatmål

Resultatmål
Tidsramme
Part A (Cohort 1, 3, 4): AUC(D1-29) following administration of sotrovimab
Tidsramme: Up to Day 29
Up to Day 29
Part A (Cohort 1, 3, 4): Cmax following administration of sotrovimab through Day 29
Tidsramme: Up to Day 29
Up to Day 29
Part A (Cohort 1, 2, 3, 4): Area under the serum concentration-time curve from time zero to infinity (AUCinf) following administration of sotrovimab at injection sites 1, 2 and 3 through Week 24
Tidsramme: Up to Week 24
Up to Week 24
Part A: Serum concentration following administration of sotrovimab through Day 29
Tidsramme: Up to Day 29
Up to Day 29
Part A: Serum concentration following administration of sotrovimab through Week 24
Tidsramme: Up to Week 24
Up to Week 24
Part A (Cohort 3, 4) and Part B: Number of participants with AEs, SAEs, and AESI
Tidsramme: Up to Day 29
Up to Day 29
Part A and Part B: Number of participants with AEs, SAEs, and AESI
Tidsramme: Up to Week 35
Up to Week 35
Part B: AUC(D1-29) following administration of sotrovimab
Tidsramme: Up to Day 29
Up to Day 29
Part B: Cmax following administration of sotrovimab through Day 29
Tidsramme: Up to Day 29
Up to Day 29
Part B: AUCinf following administration of sotrovimab at up to 2 injection sites through Week 24
Tidsramme: Up to Week 24
Up to Week 24
Part B: Serum concentration following administration of sotrovimab through Day 29
Tidsramme: Up to Day 29
Up to Day 29
Part B: Serum concentration following administration of sotrovimab through Week 24
Tidsramme: Up to Week 24
Up to Week 24
Part C: AUC(D1-29) following administration of sotrovimab
Tidsramme: Up to Day 29
Up to Day 29
Part C: Cmax following administration of sotrovimab through Day 29
Tidsramme: Up to Day 29
Up to Day 29
Part C: Serum concentration following administration of sotrovimab through Day 29
Tidsramme: Up to Day 29
Up to Day 29
Part C: Serum concentration following administration of sotrovimab through Week 24
Tidsramme: Up to Week 24
Up to Week 24
Part C: Number of participants with AEs, SAEs, and AESI
Tidsramme: Up to Week 35
Up to Week 35

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Vir Biotechnology, Inc.

Samarbejdspartnere

GlaxoSmithKline

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

28. marts 2022

Primær færdiggørelse (Forventet)

4. marts 2024

Studieafslutning (Forventet)

30. maj 2024

Datoer for studieregistrering

Først indsendt

4. marts 2022

Først indsendt, der opfyldte QC-kriterier

4. marts 2022

Først opslået (Faktiske)

15. marts 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. november 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. november 2022

Sidst verificeret

1. november 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • VIR-7831-5012
  • GSK Study 218128 (Anden identifikator: GlaxoSmithKline)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Covid19

Kliniske forsøg med sotrovimab

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Jamaica

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner