Pharmacokinetics of Depemokimab Delivered by Safety Syringe Device or Autoinjector in Healthy Adults: A Phase 1, Single‐Dose Study

• Published in: Clinical pharmacology in drug development Vol. 14; no. 3; pp. 190 - 199
• Main Authors: Schalkwijk, Stein, Zecchin, Chiara, Sen, Anusmita, Choi, Sei, Wang, Kai, Min, Jeff, Spears, Brian
• Format: Journal Article
• Language: English
• Published: United States 01.03.2025
• Subjects: Adult; Antibodies, Monoclonal, Humanized - administration & dosage; Antibodies, Monoclonal, Humanized - adverse effects; Antibodies, Monoclonal, Humanized - blood; Antibodies, Monoclonal, Humanized - pharmacokinetics; Area Under Curve; Biological Availability; biologics; depemokimab; drug metabolism; Female; Healthy Volunteers; Humans; Injections, Subcutaneous - instrumentation; Male; Middle Aged; pharmacokinetics; self‐administration; Syringes; Therapeutic Equivalency; Young Adult; pharmacokinetics; biologics; depemokimab; self‐administration; drug metabolism
• ISSN: 2160-763X; 2160-7648
• DOI: 10.1002/cpdd.1506

This Phase I, randomized, multicenter, open‐label, parallel‐group, single‐dose study assessed the relative bioavailability of the anti–interleukin‐5 antibody depemokimab (100 mg) when administered subcutaneously via either a safety syringe device (SSD) or an autoinjector (AI). Healthy adult participants were randomized I:I to SSD or AI treatment arms and I:I:I to the injection site (upper arm, abdomen, or thigh). Participants were followed up for 30 weeks; blood samples were collected for pharmacokinetic (PK) assessment before dosing on Day 1 and up to Week 26. Depemokimab concentration profile as measured by plasma maximum concentration (Cmax), the area under the concentration–time curve from time zero extrapolated to infinity (AUC0‐inf), PK parameters, immunogenicity, and safety were assessed. Overall, 140 participants were enrolled (n = 70 per arm). Mean plasma concentration‐time profiles of depemokimab were similar in both treatment arms, regardless of the injection site, adjusted geometric mean AI:SSD ratios for Cmax and AUC0‐inf were 1.03 and 1.03, respectively, with all 90% confidence intervals within the bioequivalence bounds of 0.80‐1.25. PK parameters were comparable across treatment arms. Treatment‐related adverse events were reported in 19% of SSD and 20% of AI participants, with headache being the most common across both arms; no adverse events led to study withdrawal. These results support the use of either SSD or AI for subcutaneous administration of depemokimab.