A Study of Subcutaneous Gefurulimab Using Prefilled Syringe Versus Autoinjector in Healthy Adult Participants

Last updated: October 21, 2024
Sponsor: Alexion Pharmaceuticals, Inc.
Overall Status: Completed

Phase

1

Condition

N/A

Treatment

Gefurulimab AI

Gefurulimab PFS-SD

Clinical Study ID

NCT06208488
ALXN1720-HV-103
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This study will evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, immunogenicity, and device performance of gefurulimab.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participants must be 18 to 65 years of age inclusive, at the time of signing theinformed consent.

  2. Body weight within ≥ 50 to < 110 kg and body mass index (BMI) within the range 18.5to 30 kg/m2 (inclusive)

  3. Participants who are healthy as determined by medical evaluation with no clinicallysignificant or relevant abnormalities as determined by medical history, physicalexamination, vital signs, 12-lead ECG, and clinical laboratory evaluation.

  4. QT interval corrected using Fridericia's formula (QTcF) ≤ 450 msec for maleparticipants and ≤ 460 msec for female participants at Screening and prior to dosingon Day 1.

  5. Documented vaccination against meningococcal infection from serogroups A, C, W, andY and serogroup B.

  6. Male and female participants should adhere to study-specific contraceptive methods.

Exclusion

Exclusion Criteria:

  1. History of any Neisseria meningitidis infection.

  2. History or presence of cardiovascular, respiratory, hepatic, renal,gastrointestinal, endocrinological, hematological, or neurological disorders.

  3. Abnormal blood pressure as determined by the Investigator.

  4. History of latent or active TB (Tuberculosis) or exposure to endemic areas.

  5. Allergy to monoclonal antibodies.

  6. Clinically significant multiple or severe drug allergies, intolerance to topicalcorticosteroids, or severe posttreatment hypersensitivity reactions.

  7. Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cellor squamous epithelial carcinomas of the skin that have been resected with noevidence of metastatic disease for 3 years.

  8. Current or chronic history of liver disease.

  9. Known hepatic or biliary abnormalities.

  10. Active systemic bacterial, viral, or fungal infection within 14 days prior todosing.

  11. History of allergy or intolerance to penicillin or cephalosporin.

  12. History of clinically significant allergic reaction (eg, anaphylaxis or angioedema)to any product.

  13. Live vaccine(s) within 1 month prior to Screening or plans to receive such vaccinesduring the study.

  14. Evidence of human immunodeficiency virus (HIV) infection (positive HIV type 1 ortype 2 antibody).

  15. Evidence of hepatitis B infection (positive hepatitis B surface antigen [HBsAg] orpositive total hepatitis B core antibody [HBcAb] with negative surface antibody [anti-HBs]), or hepatitis C viral infection (positive HCV RNA).

  16. Female participants who have a positive pregnancy test at Screening or Admission.

  17. Positive prestudy drug/alcohol screen; positive result may be repeated once.

Study Design

Total Participants: 175
Treatment Group(s): 2
Primary Treatment: Gefurulimab AI
Phase: 1
Study Start date:
November 22, 2023
Estimated Completion Date:
September 28, 2024

Study Description

This is an open-label, randomized, parallel-group study.

The study consists of 2 periods: a Screening Period (up to 70 days), and an Evaluation Period of 92 days.

Separate randomization lists will be produced for each weight stratum (50 to < 70 kg, 70 to < 90 kg, and 90 to < 110 kg) and within each of the three weight strata, participants will be randomized 1:1:1:1:1:1 to one of the six combinations of device (prefilled syringe with needle safety device [PFS-SD] or autoinjector [AI]) and injection site (abdomen, thigh, or upper arm),

Participants will receive a single dose of 600 mg gefurulimab on Day 1, will be residential at the clinical unit until Day 5, will have visits on Day 8, quaque week (once a week) [qw] thereafter until Day 50, and quaque 2 week (once every two weeks) [q2w] from Day 50 until Day 92 during the Evaluation Period.

The total study duration is up to 162 days.

Connect with a study center

  • Research Site

    Toronto, Ontario M9L 3A2
    Canada

    Site Not Available

  • Research Site

    Laval, Quebec h7v 4bc
    Canada

    Site Not Available

  • Research Site

    Harrow, HA1 3UJ
    United Kingdom

    Site Not Available

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