Clinical trial NCT06677138: PK Study of Gefurulimab SC in Healthy Chinese Adult Participants
Official title: A Phase 1 Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Gefurulimab (ALXN1720) in Healthy Chinese Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Chinese
gefurulimab
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2024-11-06
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Maximum Observed Serum Concentration (Cmax) of Gefurulimab
timeFrame: Day 1 predose through Day 92 postdose
measure: Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Gefurulimab
timeFrame: Day 1 predose through Day 92 postdose
Secondary outcomes:
measure: Serum Free Complement Component 5 (C5) Concentration
timeFrame: Day 1 predose through Day 92 postdose
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
timeFrame: Day 1 through Day 92
measure: Number of Participants With Anti-drug Antibodies (ADAs)
timeFrame: Day 1 through Day 92
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Associated With Prefilled Syringe With Needle Safety Device (PFS-SD)
timeFrame: Day 1 through Day 92
measure: Number of Participants With Successful and Failed Dose Administrations
timeFrame: Day 1 through Day 92
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Research Site
Study officials:
References: