> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-subcutaneous-gefurulimab-using-prefilled-syringe-2b38c6d3-63d8-4cda-add5-75ca585410cb > Record changed: 2026-10-13 # A Study of Subcutaneous Gefurulimab Using Prefilled Syringe Versus Autoinjector in Healthy Adult Participants NCT06208488 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06208488) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06208488) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06208488) Participants 175 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06208488) Lead sponsor Alexion Pharmaceuticals, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06208488) Start date 2023-11-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06208488) Number of sites 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06208488) ## Title and summary **Summary** This study will evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, immunogenicity, and device performance of gefurulimab. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06208488) **Short title** A Study of Subcutaneous Gefurulimab Using Prefilled Syringe Versus Autoinjector in Healthy Adult Participants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06208488) **Official title** A Phase 1, Open-label, Randomized, Parallel-group Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Immunogenicity, and Device Performance of ALXN1720 (Gefurulimab) Administered Subcutaneously Using Prefilled Syringe Versus Autoinjector in Adult Healthy Participants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06208488) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06208488) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06208488) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06208488) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06208488) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06208488) ## Dates **Completion date** 2024-09-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06208488) **First posted** 2024-01-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06208488) **Registry last updated** 2024-10-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06208488) **Primary completion date** 2024-09-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06208488) **Start date** 2023-11-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06208488) ## Size and sites **Actual participants** 175 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06208488) **Participants** 175 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06208488) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06208488) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06208488) **Randomisation ratio** 1:1:1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06208488) **Number of sites** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06208488) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06208488) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06208488) **Lead sponsor** Alexion Pharmaceuticals, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06208488) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06208488) ## Identifiers **Registry ID** NCT06208488 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06208488) **ClinicalTrials.gov ID** NCT06208488 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06208488) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06208488) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Single masking **Masking description** This is an open-label study. To avoid potential bias and maintain the data integrity, the analysis and reporting performed before database lock for Primary Analysis, ie, dry run/blinded data review for Primary Analysis, will be based on blinded data in which the treatment information is based on a dummy randomization schedule. **Masked roles** Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06208488) ## Outcomes ### Primary outcomes 1. Area under the serum concentration-time curve from time zero to the last measurable concentration (AUClast) Timeframe: Day 1 up to early discontinuation or Day 92 The AUClast exposure in healthy participants following a single SC dose of 600 mg gefurulimab by AI comparable to the PK exposure using the PFS-SD will be assessed. 2. Area under the serum concentration-time curve from time zero to time infinity (AUCinf) Timeframe: Day 1 up to early discontinuation or Day 92 The AUClinf exposure in healthy participants following a single SC dose of 600 mg gefurulimab by AI comparable to the PK exposure using the PFS-SD will be assessed. 3. Maximum (peak) concentration observed after study intervention administration (Cmax) Timeframe: Day 1 up to early discontinuation or Day 92 The Cmax exposure in healthy participants following a single SC dose of 600 mg gefurulimab by AI comparable to the PK exposure using the PFS-SD will be assessed. ### Secondary outcomes 1. Time to maximum observed serum concentration (tmax) Timeframe: Day 1 to Day 92 The tmax of gefurulimab SC in healthy participants across devices, and injection sites will be assessed. 2. Terminal elimination half-life (t½) Timeframe: Day 1 to Day 92 The t½ of gefurulimab SC in healthy participants across devices, and injection sites will be assessed. 3. Apparent total body clearance of the study intervention from serum (CL/F) Timeframe: Day 1 to Day 92 The CL/F of gefurulimab SC in healthy participants across devices, and injection sites will be assessed. 4. Apparent volume of distribution (Vd/F) Timeframe: Day 1 to Day 92 The Vd/F of gefurulimab SC in healthy participants across devices, and injection sites will be assessed. 5. Serum free C5 (complement component 5) concentrations Timeframe: Day 1 to Day 92 The serum free C5 concentrations of gefurulimab SC in healthy participants across devices and injection sites will be assessed. 6. Number of subjects with TEAEs (treatment-emergent adverse event) and TESAEs (treatment-emergent serious adverse event) Timeframe: From Admission (Day-1) to Day 92 The safety and tolerability of gefurulimab SC in healthy participants across devices and injection sites will be evaluated. 7. Incidence of antidrug antibody (ADA) to gefurulimab category of immune-response and titer Timeframe: Day 1, Day 92 The immunogenicity of gefurulimab SC administered with either PFS-SD or AI in healthy participants will be assessed. 8. Number of reported outcome of attempted full-dose administration via AI (autoinjector) or PFS-SD (prefilled syringe with needle safety device) Timeframe: Day 1 The performance of the AI and PFS-SD in the administration of gefurulimab SC in healthy participants will be assessed. 9. Number of reported device deficiencies/complaints and associated device investigations Timeframe: Day 1 The performance of the AI and PFS-SD in the administration of gefurulimab SC in healthy participants will be assessed. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06208488) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 65 Years **Healthy volunteers** Yes ### Inclusion criteria 1. Participants must be 18 to 65 years of age inclusive, at the time of signing the informed consent. 2. Body weight within ≥ 50 to < 110 kg and body mass index (BMI) within the range 18.5 to 30 kg/m2 (inclusive) 3. Participants who are healthy as determined by medical evaluation with no clinically significant or relevant abnormalities as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluation. 4. QT interval corrected using Fridericia's formula (QTcF) ≤ 450 msec for male participants and ≤ 460 msec for female participants at Screening and prior to dosing on Day 1. 5. Documented vaccination against meningococcal infection from serogroups A, C, W, and Y and serogroup B. 6. Male and female participants should adhere to study-specific contraceptive methods. ### Exclusion criteria 1. History of any Neisseria meningitidis infection. 2. History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders. 3. Abnormal blood pressure as determined by the Investigator. 4. History of latent or active TB (Tuberculosis) or exposure to endemic areas. 5. Allergy to monoclonal antibodies. 6. Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe posttreatment hypersensitivity reactions. 7. 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. 8. Current or chronic history of liver disease. 9. Known hepatic or biliary abnormalities. 10. Active systemic bacterial, viral, or fungal infection within 14 days prior to dosing. 11. History of allergy or intolerance to penicillin or cephalosporin. 12. History of clinically significant allergic reaction (eg, anaphylaxis or angioedema) to any product. 13. Live vaccine(s) within 1 month prior to Screening or plans to receive such vaccines during the study. 14. Evidence of human immunodeficiency virus (HIV) infection (positive HIV type 1 or type 2 antibody). 15. Evidence of hepatitis B infection (positive hepatitis B surface antigen \[HBsAg\] or positive total hepatitis B core antibody \[HBcAb\] with negative surface antibody \[anti-HBs\]), or hepatitis C viral infection (positive HCV RNA). 16. Female participants who have a positive pregnancy test at Screening or Admission. 17. Positive prestudy drug/alcohol screen; positive result may be repeated once. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06208488) ## Sites - Research SiteToronto, Canada - Research SiteLaval, Canada Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06208488) ## Related records ### Drugs (1) - [Gefurulimab](https://trialight.com/data/asset/gefurulimab-5d6adf29-dfd8-4aff-9ae0-5273f6986c61.md) ### Collaborators (1) - Parexel ### Lead sponsors (1) - [Alexion Pharmaceuticals, Inc.](https://trialight.com/data/company/alexion-pharmaceuticals-inc-4c38cf78-660e-459c-91b1-eab1bae29505.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. Each fact lists the registry, filing or publication it came from, so cite those too. - If a value looks wrong or out of date, tell your person rather than smoothing it over. 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