A Study of Subcutaneous Gefurulimab Using Prefilled Syringe Versus Autoinjector in Healthy Adult Participants

Study Identifier:
ALXN1720-HV-103
ClinicalTrials.gov Identifier:
NCT06208488
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete

Study Details

Medical Condition
  • Other
Study Drug
  • Drug: Gefurulimab PFS-SD
  • Drug: Gefurulimab AI
Date
Nov 2023 - Sep 2024
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 65 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • 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 Criteria
  • 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.
Sex
Female & Male
Age
18 - 65 Years

Study Details

Medical Condition
  • Other
Study Drug
  • Drug: Gefurulimab PFS-SD
  • Drug: Gefurulimab AI
Date
Nov 2023 - Sep 2024
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 65 Years years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • 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 Criteria
  • 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.

Protocol Summary

This study will evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, immunogenicity, and device performance of gefurulimab.

Trial Locations

Location
Status
Location
Research Site
Toronto, Ontario, Canada, M9L 3A2
Status
N/A
Location
Research Site
Laval, Quebec, Canada, h7v 4bc
Status
N/A