PK Study of Gefurulimab SC in Healthy Chinese Adult Participants

Study Identifier:
D6780C00003
ClinicalTrials.gov Identifier:
NCT06677138
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
Date
Oct 2024 - Mar 2025
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 45 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Participants must be 18 to 45 years of age, inclusive, at the time of signing the informed consent.
  • Body weight within ≥ 45 kg to \< 110 kg and BMI within the range 18 to 30 kg/m2 (inclusive) at Screening and Admission (Day -1).
  • 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.
  • QTcF ≤ 450 msec for male participants and ≤ 460 msec for female participants at Screening and prior to dosing on Day 1.
  • Documented vaccination against N meningitidis serotypes A, C, W-135, Y at least 28 days and not more than 3 years prior to dosing on Day 1.
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.
  • Active systemic bacterial, viral, or fungal infection within 14 days prior to dosing.
  • History of latent or active TB or exposure to endemic areas within 8 weeks prior to the Screening Visit confirmed by QuantiFERON®-TB test.
  • Significant allergies to humanized biologics.
  • Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions.
  • History of clinically significant allergic reaction (eg, anaphylaxis or angioedema) to any product (eg, food, pharmaceutical).
  • History of allergy or intolerance to penicillin or cephalosporin.
  • 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.
  • 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 - 45 Years

Study Details

Medical Condition
  • Other
Study Drug
  • Drug: gefurulimab
Date
Oct 2024 - Mar 2025
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 45 Years years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Participants must be 18 to 45 years of age, inclusive, at the time of signing the informed consent.
  • Body weight within ≥ 45 kg to \< 110 kg and BMI within the range 18 to 30 kg/m2 (inclusive) at Screening and Admission (Day -1).
  • 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.
  • QTcF ≤ 450 msec for male participants and ≤ 460 msec for female participants at Screening and prior to dosing on Day 1.
  • Documented vaccination against N meningitidis serotypes A, C, W-135, Y at least 28 days and not more than 3 years prior to dosing on Day 1.
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.
  • Active systemic bacterial, viral, or fungal infection within 14 days prior to dosing.
  • History of latent or active TB or exposure to endemic areas within 8 weeks prior to the Screening Visit confirmed by QuantiFERON®-TB test.
  • Significant allergies to humanized biologics.
  • Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions.
  • History of clinically significant allergic reaction (eg, anaphylaxis or angioedema) to any product (eg, food, pharmaceutical).
  • History of allergy or intolerance to penicillin or cephalosporin.
  • 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.
  • 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

The primary objective of this study is to characterize the PK properties of a single dose of gefurulimab in healthy Chinese participants.

Trial Locations

Location
Status
Location
Research Site
Shanghai, China, 201107
Status
N/A