Status:
COMPLETED
A Study of Subcutaneous Gefurulimab Using Prefilled Syringe Versus Autoinjector in Healthy Adult Participants
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Collaborating Sponsors:
Parexel
Conditions:
Healthy Adult Participants
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This study will evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, immunogenicity, and device performance of gefurulimab.
Detailed Description
This is an open-label, randomized, parallel-group study. The study consists of 2 periods: a Screening Period (up to 70 days), and an Evaluation Period of 92 days. Separate randomization lists will b...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 28 2024
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT06208488
Start Date
November 22 2023
End Date
September 28 2024
Last Update
October 23 2024
Active Locations (2)
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1
Research Site
Toronto, Ontario, Canada, M9L 3A2
2
Research Site
Laval, Quebec, Canada, h7v 4bc