Relative Bioavailability, Safety, and Tolerability of Single-dose Sotrovimab Injection in Adults (COSMIC) (COSMIC)
2 november 2022 uppdaterad 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).
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Förväntat)
504
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Study Inquiry
- Telefonnummer: 4156545281
- E-post: clinicaltrials@vir.bio
Studieorter
-
-
California
-
Riverside, California, Förenta staterna, 92503
- Rekrytering
- Investigative Site
-
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Florida
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Atlantis, Florida, Förenta staterna, 33462
- Rekrytering
- Investigative Site
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Edgewater, Florida, Förenta staterna, 32132
- Rekrytering
- Investigative Site
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Kontakt:
- Study Inquiry
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Missouri
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Saint Louis, Missouri, Förenta staterna, 63141
- Rekrytering
- Investigative Site
-
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New York
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Binghamton, New York, Förenta staterna, 13901
- Rekrytering
- Investigative Site
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Oklahoma
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Yukon, Oklahoma, Förenta staterna, 73099
- Rekrytering
- Investigative Site
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Oregon
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Medford, Oregon, Förenta staterna, 97504
- Rekrytering
- Investigative Site
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Kontakt:
- Study Inquiry
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Texas
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Austin, Texas, Förenta staterna, 78745
- Rekrytering
- Investigative Site
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Houston, Texas, Förenta staterna, 77065
- Rekrytering
- Investigative Site
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Utah
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West Jordan, Utah, Förenta staterna, 84088
- Rekrytering
- Investigative Site
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Part A Cohort 1: Concentration 1 of sotrovimab
administered at injection site 1
|
via IM injection
via IV infusion
|
|
Experimentell: Part A Cohort 2: Concentration 2 of sotrovimab
administered at injection site 1
|
via IM injection
via IV infusion
|
|
Experimentell: Part A Cohort 3: Concentration 2 of sotrovimab
administered at injection site 2
|
via IM injection
via IV infusion
|
|
Experimentell: Part A Cohort 4: Concentration 2 of sotrovimab
administered at injection site 3
|
via IM injection
via IV infusion
|
|
Experimentell: Part B Cohort 5: Concentration 1 of sotrovimab
administered at potential injection site 1,2,3 or other
|
via IM injection
via IV infusion
|
|
Experimentell: Part B Cohort 6: Concentration 2 of sotrovimab
administered at potential injection site 1,2,3 or other
|
via IM injection
via IV infusion
|
|
Experimentell: Part C Cohort 7: Concentration 2 of sotrovimab
administered by intravenous (IV) infusion
|
via IM injection
via IV infusion
|
|
Experimentell: Part C Cohort 8: Concentration 2 of sotrovimab
administered by IV infusion
|
via IM injection
via IV infusion
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
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
Tidsram: Up to Day 29
|
Up to Day 29
|
|
Part A (Cohort 1, 2): Maximum observed concentration (Cmax) following administration of sotrovimab through Day 29
Tidsram: 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
Tidsram: Up to Day 29
|
Up to Day 29
|
|
Part C (Cohort 7, 8): Number of participants with AEs, SAEs, and AESI
Tidsram: Up to Day 29
|
Up to Day 29
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Part A (Cohort 1, 3, 4): AUC(D1-29) following administration of sotrovimab
Tidsram: Up to Day 29
|
Up to Day 29
|
|
Part A (Cohort 1, 3, 4): Cmax following administration of sotrovimab through Day 29
Tidsram: 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
Tidsram: Up to Week 24
|
Up to Week 24
|
|
Part A: Serum concentration following administration of sotrovimab through Day 29
Tidsram: Up to Day 29
|
Up to Day 29
|
|
Part A: Serum concentration following administration of sotrovimab through Week 24
Tidsram: Up to Week 24
|
Up to Week 24
|
|
Part A (Cohort 3, 4) and Part B: Number of participants with AEs, SAEs, and AESI
Tidsram: Up to Day 29
|
Up to Day 29
|
|
Part A and Part B: Number of participants with AEs, SAEs, and AESI
Tidsram: Up to Week 35
|
Up to Week 35
|
|
Part B: AUC(D1-29) following administration of sotrovimab
Tidsram: Up to Day 29
|
Up to Day 29
|
|
Part B: Cmax following administration of sotrovimab through Day 29
Tidsram: Up to Day 29
|
Up to Day 29
|
|
Part B: AUCinf following administration of sotrovimab at up to 2 injection sites through Week 24
Tidsram: Up to Week 24
|
Up to Week 24
|
|
Part B: Serum concentration following administration of sotrovimab through Day 29
Tidsram: Up to Day 29
|
Up to Day 29
|
|
Part B: Serum concentration following administration of sotrovimab through Week 24
Tidsram: Up to Week 24
|
Up to Week 24
|
|
Part C: AUC(D1-29) following administration of sotrovimab
Tidsram: Up to Day 29
|
Up to Day 29
|
|
Part C: Cmax following administration of sotrovimab through Day 29
Tidsram: Up to Day 29
|
Up to Day 29
|
|
Part C: Serum concentration following administration of sotrovimab through Day 29
Tidsram: Up to Day 29
|
Up to Day 29
|
|
Part C: Serum concentration following administration of sotrovimab through Week 24
Tidsram: Up to Week 24
|
Up to Week 24
|
|
Part C: Number of participants with AEs, SAEs, and AESI
Tidsram: Up to Week 35
|
Up to Week 35
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
28 mars 2022
Primärt slutförande (Förväntat)
4 mars 2024
Avslutad studie (Förväntat)
30 maj 2024
Studieregistreringsdatum
Först inskickad
4 mars 2022
Först inskickad som uppfyllde QC-kriterierna
4 mars 2022
Första postat (Faktisk)
15 mars 2022
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
8 november 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 november 2022
Senast verifierad
1 november 2022
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- VIR-7831-5012
- GSK Study 218128 (Annan identifierare: GlaxoSmithKline)
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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