Safety and tolerability of intramuscular sotrovimab administered at different injection sites: results from the Phase 1 COSMIC study
Monoclonal antibodies (mAbs) administered using intramuscular (IM) injections could offer a convenient and accessible therapeutic option. However, there is a paucity of data on IM tolerability by injection site to guide mAb development. This Phase 1, open-label trial randomized healthy adults to rec...
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Taylor & Francis Group
2025-12-01
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| Series: | mAbs |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/19420862.2025.2456467 |
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| author | Jennifer Moore Alicia Aylott Wen-Hung Chen Jerzy Daniluk Ian A. Hawes Sergio Parra Prosenjit Sarkar Yasmin Sanchez-Pearson Megan Turner Amanda Peppercorn Andrew Skingsley |
| author_facet | Jennifer Moore Alicia Aylott Wen-Hung Chen Jerzy Daniluk Ian A. Hawes Sergio Parra Prosenjit Sarkar Yasmin Sanchez-Pearson Megan Turner Amanda Peppercorn Andrew Skingsley |
| author_sort | Jennifer Moore |
| collection | DOAJ |
| description | Monoclonal antibodies (mAbs) administered using intramuscular (IM) injections could offer a convenient and accessible therapeutic option. However, there is a paucity of data on IM tolerability by injection site to guide mAb development. This Phase 1, open-label trial randomized healthy adults to receive 62.5 mg/mL sotrovimab IM into each dorsogluteal muscle (2 × 4 mL injections), or 100 mg/mL sotrovimab IM into the dorsogluteal muscle (1 × 5 mL), the anterolateral thigh muscle (1 × 5 mL) or each deltoid muscle (2 × 2.5 mL). Incidence of adverse events (AEs), serious AEs (SAEs) and AEs of special interest (AESIs) were assessed, along with patient-reported outcomes (Perception of Injection version 3 questionnaire and Pain-Numeric Rating Scale [Pain-NRS]). Of 329 participants screened, 215 (65%) received sotrovimab (median age 39 [range 19–65] years; 57% female; mean body mass index 25.4 kg/m2). Overall, 46% (n = 99/215) of participants reported AEs; the most common was injection site pain (30%; n = 65/215). There were no SAEs reported, and all AESIs were Grade 1 or 2. Through Day 8, mean Pain-NRS values were < 1 and similar across injection sites; values were highest on Day 1 at 15 minutes post-dosing and decreased over time through Day 8. Injection site reactions were reported by all participants as ‘not at all’ or ‘a little’ bothersome. No or little impact on sleep and movement was reported. Sotrovimab IM was generally well tolerated at all injection sites, at volumes up to 5 mL (dorsogluteal and anterolateral thigh) and as one 2.5 mL injection into each deltoid muscle. To our knowledge, these are the first data to show that a >2 mL mAb injection into each deltoid muscle is well tolerated.Trial registration ClinicalTrials.gov identifier, NCT05280717 |
| format | Article |
| id | doaj-art-6c05d3e1fa364e279c2b65461a52f26a |
| institution | Kabale University |
| issn | 1942-0862 1942-0870 |
| language | English |
| publishDate | 2025-12-01 |
| publisher | Taylor & Francis Group |
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| series | mAbs |
| spelling | doaj-art-6c05d3e1fa364e279c2b65461a52f26a2025-01-30T06:53:00ZengTaylor & Francis GroupmAbs1942-08621942-08702025-12-0117110.1080/19420862.2025.2456467Safety and tolerability of intramuscular sotrovimab administered at different injection sites: results from the Phase 1 COSMIC studyJennifer Moore0Alicia Aylott1Wen-Hung Chen2Jerzy Daniluk3Ian A. Hawes4Sergio Parra5Prosenjit Sarkar6Yasmin Sanchez-Pearson7Megan Turner8Amanda Peppercorn9Andrew Skingsley10GSK, Brentford, UKGSK, Stevenage, UKGSK, Collegeville, PA, USAGSK, Warsaw, PolandGSK, Mississauga, ON, CanadaVir Biotechnology, Inc., San Francisco, CA, USAGSK, Bengaluru, IndiaGSK, Brentford, UKGSK, Collegeville, PA, USAGSK, Cambridge, MA, USAGSK, Brentford, UKMonoclonal antibodies (mAbs) administered using intramuscular (IM) injections could offer a convenient and accessible therapeutic option. However, there is a paucity of data on IM tolerability by injection site to guide mAb development. This Phase 1, open-label trial randomized healthy adults to receive 62.5 mg/mL sotrovimab IM into each dorsogluteal muscle (2 × 4 mL injections), or 100 mg/mL sotrovimab IM into the dorsogluteal muscle (1 × 5 mL), the anterolateral thigh muscle (1 × 5 mL) or each deltoid muscle (2 × 2.5 mL). Incidence of adverse events (AEs), serious AEs (SAEs) and AEs of special interest (AESIs) were assessed, along with patient-reported outcomes (Perception of Injection version 3 questionnaire and Pain-Numeric Rating Scale [Pain-NRS]). Of 329 participants screened, 215 (65%) received sotrovimab (median age 39 [range 19–65] years; 57% female; mean body mass index 25.4 kg/m2). Overall, 46% (n = 99/215) of participants reported AEs; the most common was injection site pain (30%; n = 65/215). There were no SAEs reported, and all AESIs were Grade 1 or 2. Through Day 8, mean Pain-NRS values were < 1 and similar across injection sites; values were highest on Day 1 at 15 minutes post-dosing and decreased over time through Day 8. Injection site reactions were reported by all participants as ‘not at all’ or ‘a little’ bothersome. No or little impact on sleep and movement was reported. Sotrovimab IM was generally well tolerated at all injection sites, at volumes up to 5 mL (dorsogluteal and anterolateral thigh) and as one 2.5 mL injection into each deltoid muscle. To our knowledge, these are the first data to show that a >2 mL mAb injection into each deltoid muscle is well tolerated.Trial registration ClinicalTrials.gov identifier, NCT05280717https://www.tandfonline.com/doi/10.1080/19420862.2025.2456467COVID-19injection-site reactionintramuscularmonoclonal antibodypainpatient-reported outcome |
| spellingShingle | Jennifer Moore Alicia Aylott Wen-Hung Chen Jerzy Daniluk Ian A. Hawes Sergio Parra Prosenjit Sarkar Yasmin Sanchez-Pearson Megan Turner Amanda Peppercorn Andrew Skingsley Safety and tolerability of intramuscular sotrovimab administered at different injection sites: results from the Phase 1 COSMIC study mAbs COVID-19 injection-site reaction intramuscular monoclonal antibody pain patient-reported outcome |
| title | Safety and tolerability of intramuscular sotrovimab administered at different injection sites: results from the Phase 1 COSMIC study |
| title_full | Safety and tolerability of intramuscular sotrovimab administered at different injection sites: results from the Phase 1 COSMIC study |
| title_fullStr | Safety and tolerability of intramuscular sotrovimab administered at different injection sites: results from the Phase 1 COSMIC study |
| title_full_unstemmed | Safety and tolerability of intramuscular sotrovimab administered at different injection sites: results from the Phase 1 COSMIC study |
| title_short | Safety and tolerability of intramuscular sotrovimab administered at different injection sites: results from the Phase 1 COSMIC study |
| title_sort | safety and tolerability of intramuscular sotrovimab administered at different injection sites results from the phase 1 cosmic study |
| topic | COVID-19 injection-site reaction intramuscular monoclonal antibody pain patient-reported outcome |
| url | https://www.tandfonline.com/doi/10.1080/19420862.2025.2456467 |
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