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Phase 1 Study Evaluating Gefurulimab Pharmacokinetics and Safety Following Delivery Via Autoinjector or Prefilled Syringe With Needle Safety Device in Healthy Adults.

Alanna McEneny·Xiangyu Cong·Min Yee·Praveen Amancha·Alyssa Easton·Olivia Tong
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Abstract

PURPOSE: Gefurulimab, a novel dual-binding nanobody targeting complement component 5 (C5), is in clinical development for anti-acetylcholine receptor antibody-positive generalized myasthenia gravis. Gefurulimab has a low molecular weight, enabling subcutaneous (SC) self-administration by autoinjector (AI) or prefilled syringe with needle safety device (PFS-SD). We compared gefurulimab pharmacokinetic (PK) exposure and safety in healthy adults following a single SC dose administered by AI versus PFS-SD. METHODS: In this phase 1, open-label, randomized, parallel-group study (NCT06208488), healthy participants aged 18 to 65 years were stratified by weight and randomized equally to 1 of 6 combination groups of device and injection site (abdomen/thigh/upper arm). Participants received a single SC dose of gefurulimab on day 1 and were assessed throughout the 92-day evaluation period. Primary endpoints were PK parameters for each device: maximum observed concentration (Cmax) and area under the serum concentration-time curve (AUCinf, AUClast). PK across injection sites, pharmacodynamics, safety, immunogenicity, and device performance were also assessed. FINDINGS: Overall, 175 participants were randomized: AI (n = 87), PFS-SD (n = 88). Geometric least squares mean ratios (90% CI) comparing AI/PFS-SD for Cmax, AUCinf, and AUClast were 97.6% (94.5-100.8), 99.6% (96.1-103.3), and 98.8% (95.2‒102.6), respectively. Secondary analyses found no meaningful differences in PK parameters across injection sites. Serum-free C5 concentrations over time, treatment-emergent adverse event (TEAE) profiles, and antidrug antibody responses were similar between cohorts. Most TEAEs were mild; none led to study discontinuation. IMPLICATIONS: SC administration of gefurulimab by AI and PFS-SD was well tolerated with comparable exposure, meeting bioequivalence criteria.

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HumansAdultMaleMiddle AgedFemaleYoung AdultInjections, SubcutaneousAdolescentSyringesAgedAntibodies, Monoclonal, HumanizedArea Under CurveNeedlesSelf AdministrationHealthy VolunteersAutoinjectorGefurulimabGeneralized myasthenia gravisNCT06208488Pharmacodynamics/pharmacokineticsPrefilled syringe with needle safety deviceJournal ArticleRandomized Controlled TrialClinical Trial, Phase IComparative Study

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Alanna McEneny, Xiangyu Cong, Min Yee, Praveen Amancha, Alyssa Easton, Olivia Tong. 2026-06-30. Phase 1 Study Evaluating Gefurulimab Pharmacokinetics and Safety Following Delivery Via Autoinjector or Prefilled Syringe With Needle Safety Device in Healthy Adults.. https://doi.org/10.1016/j.clinthera.2026.06.001

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Adolescent subjectAdult subjectAged subjectAntibodies, Monoclonal, Humanized subjectClinical Trial, Phase I subjectComparative Study subjectFemale subjectHealthy Volunteers subjectHumans subjectInjections, Subcutaneous subjectJournal Article subjectMale subjectMiddle Aged subjectNeedles subjectRandomized controlled trials study

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