A Study of Subcutaneous Gefurulimab Using Prefilled Syringe Versus Autoinjector in Healthy Adult Participants
- Summary
- This study will evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, immunogenicity, and device performance of gefurulimab.
- Short title
- A Study of Subcutaneous Gefurulimab Using Prefilled Syringe Versus Autoinjector in Healthy Adult Participants
- 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
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2024-09-28
- First posted
- 2024-01-17
- Registry last updated
- 2024-10-23
- Primary completion date
- 2024-09-17
- Start date
- 2023-11-22
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Randomisation ratio
- 1:1:1:1
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06208488
- ClinicalTrials.gov ID
- NCT06208488
- Registry record
- Open registry record
- 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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 65 Years
- Healthy volunteers
- Yes
- Participants must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
- Body weight within ≥ 50 to < 110 kg and body mass index (BMI) within the range 18.5 to 30 kg/m2 (inclusive)
- 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.
- 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.
- Documented vaccination against meningococcal infection from serogroups A, C, W, and Y and serogroup B.
- Male and female participants should adhere to study-specific contraceptive methods.
- History of any Neisseria meningitidis infection.
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders.
- Abnormal blood pressure as determined by the Investigator.
- History of latent or active TB (Tuberculosis) or exposure to endemic areas.
- Allergy to monoclonal antibodies.
- Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe posttreatment hypersensitivity reactions.
- 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.
- Current or chronic history of liver disease.
- Known hepatic or biliary abnormalities.
- Active systemic bacterial, viral, or fungal infection within 14 days prior to dosing.
- History of allergy or intolerance to penicillin or cephalosporin.
- History of clinically significant allergic reaction (eg, anaphylaxis or angioedema) to any product.
- Live vaccine(s) within 1 month prior to Screening or plans to receive such vaccines during the study.
- Evidence of human immunodeficiency virus (HIV) infection (positive HIV type 1 or type 2 antibody).
- 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).
- Female participants who have a positive pregnancy test at Screening or Admission.
- Positive prestudy drug/alcohol screen; positive result may be repeated once.
- Research SiteToronto, Canada
- Research SiteLaval, Canada
Related records
Drugs (1)
Collaborators (1)
- Parexel