Relative Bioavailability, Safety, and Tolerability of Single-dose Sotrovimab Injection in Adults (COSMIC) (COSMIC)
2 novembre 2022 mis à jour par: 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).
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Anticipé)
504
Phase
- La phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Study Inquiry
- Numéro de téléphone: 4156545281
- E-mail: clinicaltrials@vir.bio
Lieux d'étude
-
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California
-
Riverside, California, États-Unis, 92503
- Recrutement
- Investigative Site
-
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Florida
-
Atlantis, Florida, États-Unis, 33462
- Recrutement
- Investigative Site
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Edgewater, Florida, États-Unis, 32132
- Recrutement
- Investigative Site
-
Contact:
- Study Inquiry
-
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Missouri
-
Saint Louis, Missouri, États-Unis, 63141
- Recrutement
- Investigative Site
-
-
New York
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Binghamton, New York, États-Unis, 13901
- Recrutement
- Investigative Site
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Oklahoma
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Yukon, Oklahoma, États-Unis, 73099
- Recrutement
- Investigative Site
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Oregon
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Medford, Oregon, États-Unis, 97504
- Recrutement
- Investigative Site
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Contact:
- Study Inquiry
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Texas
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Austin, Texas, États-Unis, 78745
- Recrutement
- Investigative Site
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Houston, Texas, États-Unis, 77065
- Recrutement
- Investigative Site
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Utah
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West Jordan, Utah, États-Unis, 84088
- Recrutement
- Investigative Site
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Part A Cohort 1: Concentration 1 of sotrovimab
administered at injection site 1
|
via IM injection
via IV infusion
|
|
Expérimental: Part A Cohort 2: Concentration 2 of sotrovimab
administered at injection site 1
|
via IM injection
via IV infusion
|
|
Expérimental: Part A Cohort 3: Concentration 2 of sotrovimab
administered at injection site 2
|
via IM injection
via IV infusion
|
|
Expérimental: Part A Cohort 4: Concentration 2 of sotrovimab
administered at injection site 3
|
via IM injection
via IV infusion
|
|
Expérimental: Part B Cohort 5: Concentration 1 of sotrovimab
administered at potential injection site 1,2,3 or other
|
via IM injection
via IV infusion
|
|
Expérimental: Part B Cohort 6: Concentration 2 of sotrovimab
administered at potential injection site 1,2,3 or other
|
via IM injection
via IV infusion
|
|
Expérimental: Part C Cohort 7: Concentration 2 of sotrovimab
administered by intravenous (IV) infusion
|
via IM injection
via IV infusion
|
|
Expérimental: Part C Cohort 8: Concentration 2 of sotrovimab
administered by IV infusion
|
via IM injection
via IV infusion
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
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
Délai: Up to Day 29
|
Up to Day 29
|
|
Part A (Cohort 1, 2): Maximum observed concentration (Cmax) following administration of sotrovimab through Day 29
Délai: 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
Délai: Up to Day 29
|
Up to Day 29
|
|
Part C (Cohort 7, 8): Number of participants with AEs, SAEs, and AESI
Délai: Up to Day 29
|
Up to Day 29
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Part A (Cohort 1, 3, 4): AUC(D1-29) following administration of sotrovimab
Délai: Up to Day 29
|
Up to Day 29
|
|
Part A (Cohort 1, 3, 4): Cmax following administration of sotrovimab through Day 29
Délai: 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
Délai: Up to Week 24
|
Up to Week 24
|
|
Part A: Serum concentration following administration of sotrovimab through Day 29
Délai: Up to Day 29
|
Up to Day 29
|
|
Part A: Serum concentration following administration of sotrovimab through Week 24
Délai: Up to Week 24
|
Up to Week 24
|
|
Part A (Cohort 3, 4) and Part B: Number of participants with AEs, SAEs, and AESI
Délai: Up to Day 29
|
Up to Day 29
|
|
Part A and Part B: Number of participants with AEs, SAEs, and AESI
Délai: Up to Week 35
|
Up to Week 35
|
|
Part B: AUC(D1-29) following administration of sotrovimab
Délai: Up to Day 29
|
Up to Day 29
|
|
Part B: Cmax following administration of sotrovimab through Day 29
Délai: Up to Day 29
|
Up to Day 29
|
|
Part B: AUCinf following administration of sotrovimab at up to 2 injection sites through Week 24
Délai: Up to Week 24
|
Up to Week 24
|
|
Part B: Serum concentration following administration of sotrovimab through Day 29
Délai: Up to Day 29
|
Up to Day 29
|
|
Part B: Serum concentration following administration of sotrovimab through Week 24
Délai: Up to Week 24
|
Up to Week 24
|
|
Part C: AUC(D1-29) following administration of sotrovimab
Délai: Up to Day 29
|
Up to Day 29
|
|
Part C: Cmax following administration of sotrovimab through Day 29
Délai: Up to Day 29
|
Up to Day 29
|
|
Part C: Serum concentration following administration of sotrovimab through Day 29
Délai: Up to Day 29
|
Up to Day 29
|
|
Part C: Serum concentration following administration of sotrovimab through Week 24
Délai: Up to Week 24
|
Up to Week 24
|
|
Part C: Number of participants with AEs, SAEs, and AESI
Délai: Up to Week 35
|
Up to Week 35
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
28 mars 2022
Achèvement primaire (Anticipé)
4 mars 2024
Achèvement de l'étude (Anticipé)
30 mai 2024
Dates d'inscription aux études
Première soumission
4 mars 2022
Première soumission répondant aux critères de contrôle qualité
4 mars 2022
Première publication (Réel)
15 mars 2022
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
8 novembre 2022
Dernière mise à jour soumise répondant aux critères de contrôle qualité
2 novembre 2022
Dernière vérification
1 novembre 2022
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- VIR-7831-5012
- GSK Study 218128 (Autre identifiant: GlaxoSmithKline)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .