Eptinezumab administered intravenously, subcutaneously, or intramuscularly in healthy subjects and/or patients with migraine: Early development studies
Objective: To report the safety, tolerability, and pharmacokinetics/pharmacodynamics (PK/PD) of eptinezumab using intravenous (IV) infusion compared to other routes of administration from two phase 1 trials. Methods: Study 1 (NCT01579383) and Study 2 (ACTRN12615000531516) were double-blind, placebo-...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
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SAGE Publishing
2022-10-01
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| Series: | Cephalalgia Reports |
| Online Access: | https://doi.org/10.1177/25158163221131326 |
| _version_ | 1797304102327156736 |
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| author | Brian Baker Vivienne Shen Roger Cady Anders Ettrup Frank Larsen |
| author_facet | Brian Baker Vivienne Shen Roger Cady Anders Ettrup Frank Larsen |
| author_sort | Brian Baker |
| collection | DOAJ |
| description | Objective: To report the safety, tolerability, and pharmacokinetics/pharmacodynamics (PK/PD) of eptinezumab using intravenous (IV) infusion compared to other routes of administration from two phase 1 trials. Methods: Study 1 (NCT01579383) and Study 2 (ACTRN12615000531516) were double-blind, placebo-controlled, randomized trials. Study 1 singly administered ascending doses of eptinezumab 1–1000 mg IV infusion or 100 mg subcutaneous (SC) injection to healthy adults on day 1 ( n = 60); in a second part, eptinezumab 300 mg IV + sumatriptan 6 mg SC was administered to healthy adults and patients with migraine ( n = 18). Study 2 administered eptinezumab 100 or 300 mg intramuscular (IM), 100 mg SC, or 100 mg IV to healthy adults on days 1 and 84 ( n = 60). Results: No withdrawals due to treatment-emergent adverse events (TEAEs) were reported due to IV administration, with IV generally reporting TEAEs similar to placebo. The pharmacokinetics of eptinezumab were as expected for a monoclonal antibody, with the 100 mg and 300 mg IV doses exhibiting higher C max and shorter t max compared to identical SC and IM doses. Discussion: These phase 1 safety and tolerability data supported eptinezumab intravenous infusions at 100 and 300 mg; both were approved for migraine prevention, were well tolerated, had low immunogenicity and rapid attainment of high plasma concentrations. |
| first_indexed | 2024-03-08T00:03:31Z |
| format | Article |
| id | doaj.art-e780e545bf7d41bfad3f16260884796b |
| institution | Directory Open Access Journal |
| issn | 2515-8163 |
| language | English |
| last_indexed | 2024-03-08T00:03:31Z |
| publishDate | 2022-10-01 |
| publisher | SAGE Publishing |
| record_format | Article |
| series | Cephalalgia Reports |
| spelling | doaj.art-e780e545bf7d41bfad3f16260884796b2024-02-17T19:03:19ZengSAGE PublishingCephalalgia Reports2515-81632022-10-01510.1177/25158163221131326Eptinezumab administered intravenously, subcutaneously, or intramuscularly in healthy subjects and/or patients with migraine: Early development studiesBrian Baker0Vivienne Shen1Roger Cady2Anders Ettrup3Frank Larsen4 Lundbeck Seattle BioPharmaceuticals, Inc., Bothell, WA, USA Lundbeck LLC, Deerfield, IL, USA Missouri State University, Springfield, MO, USA Lundbeck A/S, Copenhagen, Denmark Lundbeck A/S, Copenhagen, DenmarkObjective: To report the safety, tolerability, and pharmacokinetics/pharmacodynamics (PK/PD) of eptinezumab using intravenous (IV) infusion compared to other routes of administration from two phase 1 trials. Methods: Study 1 (NCT01579383) and Study 2 (ACTRN12615000531516) were double-blind, placebo-controlled, randomized trials. Study 1 singly administered ascending doses of eptinezumab 1–1000 mg IV infusion or 100 mg subcutaneous (SC) injection to healthy adults on day 1 ( n = 60); in a second part, eptinezumab 300 mg IV + sumatriptan 6 mg SC was administered to healthy adults and patients with migraine ( n = 18). Study 2 administered eptinezumab 100 or 300 mg intramuscular (IM), 100 mg SC, or 100 mg IV to healthy adults on days 1 and 84 ( n = 60). Results: No withdrawals due to treatment-emergent adverse events (TEAEs) were reported due to IV administration, with IV generally reporting TEAEs similar to placebo. The pharmacokinetics of eptinezumab were as expected for a monoclonal antibody, with the 100 mg and 300 mg IV doses exhibiting higher C max and shorter t max compared to identical SC and IM doses. Discussion: These phase 1 safety and tolerability data supported eptinezumab intravenous infusions at 100 and 300 mg; both were approved for migraine prevention, were well tolerated, had low immunogenicity and rapid attainment of high plasma concentrations.https://doi.org/10.1177/25158163221131326 |
| spellingShingle | Brian Baker Vivienne Shen Roger Cady Anders Ettrup Frank Larsen Eptinezumab administered intravenously, subcutaneously, or intramuscularly in healthy subjects and/or patients with migraine: Early development studies Cephalalgia Reports |
| title | Eptinezumab administered intravenously, subcutaneously, or intramuscularly in healthy subjects and/or patients with migraine: Early development studies |
| title_full | Eptinezumab administered intravenously, subcutaneously, or intramuscularly in healthy subjects and/or patients with migraine: Early development studies |
| title_fullStr | Eptinezumab administered intravenously, subcutaneously, or intramuscularly in healthy subjects and/or patients with migraine: Early development studies |
| title_full_unstemmed | Eptinezumab administered intravenously, subcutaneously, or intramuscularly in healthy subjects and/or patients with migraine: Early development studies |
| title_short | Eptinezumab administered intravenously, subcutaneously, or intramuscularly in healthy subjects and/or patients with migraine: Early development studies |
| title_sort | eptinezumab administered intravenously subcutaneously or intramuscularly in healthy subjects and or patients with migraine early development studies |
| url | https://doi.org/10.1177/25158163221131326 |
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