PK Study of Gefurulimab SC in Healthy Chinese Adult Participants

NCT06677138 | Completed Phase 1

• 1 other identifier: D6780C00003
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Chinese; gefurulimab

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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

Study Arms (1)

gefurulimab

EXPERIMENTAL

Participants will receive a single SC dose of gefurulimab in the abdomen on Day 1.

Drug: gefurulimab

Interventions

gefurulimab DRUG

Participants will receive gefurulimab subcutaneously (SC).

gefurulimab

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexion Pharmaceuticals, Inc.: lead

Study Sites (1)

Research Site

Shanghai, 201107, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 6, 2024
• Study Start: October 28, 2024
• Primary Completion: March 19, 2025
• Study Completion: March 19, 2025
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

CN (1)