PK Study of Gefurulimab SC in Healthy Chinese Adult Participants
- Registration Number
- NCT06677138
- Lead Sponsor
- Alexion Pharmaceuticals, Inc.
- Brief Summary
The primary objective of this study is to characterize the PK properties of a single dose of gefurulimab in healthy Chinese participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description gefurulimab gefurulimab Participants will receive a single SC dose of gefurulimab in the abdomen on Day 1.
- Primary Outcome Measures
Name Time Method Maximum Observed Serum Concentration (Cmax) of Gefurulimab Day 1 predose through Day 92 postdose Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Gefurulimab Day 1 predose through Day 92 postdose
- Secondary Outcome Measures
Name Time Method Serum Free Complement Component 5 (C5) Concentration Day 1 predose through Day 92 postdose Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) Day 1 through Day 92 Number of Participants With Anti-drug Antibodies (ADAs) Day 1 through Day 92 Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Associated With Prefilled Syringe With Needle Safety Device (PFS-SD) Day 1 through Day 92 Number of Participants With Successful and Failed Dose Administrations Day 1 through Day 92
Trial Locations
- Locations (1)
Research Site
🇨🇳Shanghai, China