Relative Bioavailability, Safety, and Tolerability of Single-dose Sotrovimab Injection in Adults (COSMIC) (COSMIC)
2. november 2022 oppdatert av: 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).
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Forventet)
504
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: Study Inquiry
- Telefonnummer: 4156545281
- E-post: clinicaltrials@vir.bio
Studiesteder
-
-
California
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Riverside, California, Forente stater, 92503
- Rekruttering
- Investigative Site
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Florida
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Atlantis, Florida, Forente stater, 33462
- Rekruttering
- Investigative Site
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Edgewater, Florida, Forente stater, 32132
- Rekruttering
- Investigative Site
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Ta kontakt med:
- Study Inquiry
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Missouri
-
Saint Louis, Missouri, Forente stater, 63141
- Rekruttering
- Investigative Site
-
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New York
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Binghamton, New York, Forente stater, 13901
- Rekruttering
- Investigative Site
-
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Oklahoma
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Yukon, Oklahoma, Forente stater, 73099
- Rekruttering
- Investigative Site
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Oregon
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Medford, Oregon, Forente stater, 97504
- Rekruttering
- Investigative Site
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Ta kontakt med:
- Study Inquiry
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Texas
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Austin, Texas, Forente stater, 78745
- Rekruttering
- Investigative Site
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Houston, Texas, Forente stater, 77065
- Rekruttering
- Investigative Site
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Utah
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West Jordan, Utah, Forente stater, 84088
- Rekruttering
- Investigative Site
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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
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
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: Part A Cohort 1: Concentration 1 of sotrovimab
administered at injection site 1
|
via IM injection
via IV infusion
|
|
Eksperimentell: Part A Cohort 2: Concentration 2 of sotrovimab
administered at injection site 1
|
via IM injection
via IV infusion
|
|
Eksperimentell: Part A Cohort 3: Concentration 2 of sotrovimab
administered at injection site 2
|
via IM injection
via IV infusion
|
|
Eksperimentell: Part A Cohort 4: Concentration 2 of sotrovimab
administered at injection site 3
|
via IM injection
via IV infusion
|
|
Eksperimentell: Part B Cohort 5: Concentration 1 of sotrovimab
administered at potential injection site 1,2,3 or other
|
via IM injection
via IV infusion
|
|
Eksperimentell: Part B Cohort 6: Concentration 2 of sotrovimab
administered at potential injection site 1,2,3 or other
|
via IM injection
via IV infusion
|
|
Eksperimentell: Part C Cohort 7: Concentration 2 of sotrovimab
administered by intravenous (IV) infusion
|
via IM injection
via IV infusion
|
|
Eksperimentell: Part C Cohort 8: Concentration 2 of sotrovimab
administered by IV infusion
|
via IM injection
via IV infusion
|
Hva måler studien?
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
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)
28. mars 2022
Primær fullføring (Forventet)
4. mars 2024
Studiet fullført (Forventet)
30. mai 2024
Datoer for studieregistrering
Først innsendt
4. mars 2022
Først innsendt som oppfylte QC-kriteriene
4. mars 2022
Først lagt ut (Faktiske)
15. mars 2022
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. november 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. november 2022
Sist bekreftet
1. november 2022
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- VIR-7831-5012
- GSK Study 218128 (Annen identifikator: GlaxoSmithKline)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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