PK Study of Gefurulimab SC in Healthy Chinese Adult Participants

Alexion Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: gefurulimab

Study type

Interventional

Funder types

Industry

Identifiers

NCT06677138

D6780C00003

Details and patient eligibility

About

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

Enrollment

8 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.