A Study of subcutaneous Gefurulimab Using Prefilled Syringe versus Autoinjector in Healthy Adult Participants

Study identifier:ALXN1720-HV-103

ClinicalTrials.gov identifier:NCT06208488

EudraCT identifier:N/A

CTIS identifier:N/A

Recruitment Complete

Official Title

A Phase 1, Open-label, Randomized, Parallel-group Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Immunogenicity, and Device Performance of ALXN1720 (Gefurulimab) Administered Subcutaneously Using Prefilled Syringe Versus Autoinjector in Adult Healthy Participants

Medical condition

Healthy Adult Participants

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Gefurulimab PFS-SD, Gefurulimab AI

Sex

All

Actual Enrollment

175

Study type

Interventional

Age

18 Years - 65 Years

Date

Study Start Date: 22 Nov 2023

Estimated Primary Completion Date: 18 Sept 2024

Estimated Study Completion Date: 23 Oct 2024

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jul 2024 by Alexion Pharmaceuticals, Inc.

Collaborators

PAREXEL

Inclusion and exclusion criteria

Inclusion Criteria

1. Participants must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
2. Body weight within ≥ 50 to < 110 kg and body mass index (BMI) within the range 18.5 to 30 kg/m2 (inclusive)
3. 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.
4. QT interval corrected using Fridericia’s formula (QTcF) ≤ 450 msec for male participants and ≤ 460 msec for female participants at Screening and prior to dosing on Day 1.
5. Documented vaccination against meningococcal infection from serogroups A, C, W, and Y and serogroup B.
6. Male and female participants should adhere to study-specific contraceptive methods.

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 topical corticosteroids, or severe posttreatment hypersensitivity reactions.
7. 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.
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 to dosing.
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 vaccines during the study.
14. Evidence of human immunodeficiency virus (HIV) infection (positive HIV type 1 or type 2 antibody).
15. 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).
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.

No locations available

Arms	Assigned Interventions
Experimental: Gefurulimab PFS-SD Participants will be administered gefurulimab as a single dose of 600 mg by PFS-SD on the abdomen, thigh, or upper arm.	Drug: Gefurulimab PFS-SD Participants will receive a single 600 mg dose of Gefurulimab PFS-SD subcutaneously (SC) on Day 1. Other Name: ALXN1720
Experimental: Gefurulimab AI Participants will be administered gefurulimab as a single dose of 600 mg by AI on the abdomen, thigh, or upper arm.	Drug: Gefurulimab AI Participants will receive a single 600 mg dose of Gefurulimab AI subcutaneously (SC) on Day 1. Other Name: ALXN1720

Contacts

Contact

Alexion Pharmaceuticals, Inc. (Sponsor)

1-855-752-2356

[email protected]