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

NCT06208488 | Completed Phase 1

• 1 other identifier: ALXN1720-HV-103
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Healthy Adult Participants

Keywords

Pharmacokinetics; Pharmacodynamics; Safety; Immunogenicity; Device Performance

Outcome Measures

Primary Outcomes (3)

• Area under the serum concentration-time curve from time zero to the last measurable concentration (AUClast)

  The AUClast exposure in healthy participants following a single SC dose of 600 mg gefurulimab by AI comparable to the PK exposure using the PFS-SD will be assessed.

  Day 1 up to early discontinuation or Day 92

• Area under the serum concentration-time curve from time zero to time infinity (AUCinf)

  The AUClinf exposure in healthy participants following a single SC dose of 600 mg gefurulimab by AI comparable to the PK exposure using the PFS-SD will be assessed.

  Day 1 up to early discontinuation or Day 92

• Maximum (peak) concentration observed after study intervention administration (Cmax)

  The Cmax exposure in healthy participants following a single SC dose of 600 mg gefurulimab by AI comparable to the PK exposure using the PFS-SD will be assessed.

  Day 1 up to early discontinuation or Day 92

Secondary Outcomes (9)

• Time to maximum observed serum concentration (tmax)

  Day 1 to Day 92

• Terminal elimination half-life (t½)

  Day 1 to Day 92

• Apparent total body clearance of the study intervention from serum (CL/F)

  Day 1 to Day 92

• Apparent volume of distribution (Vd/F)

  Day 1 to Day 92

• Serum free C5 (complement component 5) concentrations

  Day 1 to Day 92

Study Arms (2)

Gefurulimab PFS-SD

EXPERIMENTAL

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

Gefurulimab AI

EXPERIMENTAL

Participants will be administered gefurulimab as a single dose of 600 mg by AI on the abdomen, thigh, or upper arm.

Drug: Gefurulimab AI

Interventions

Gefurulimab PFS-SD DRUG

Participants will receive a single 600 mg dose of Gefurulimab PFS-SD subcutaneously (SC) on Day 1.

Also known as: ALXN1720

Gefurulimab PFS-SD

Gefurulimab AI DRUG

Participants will receive a single 600 mg dose of Gefurulimab AI subcutaneously (SC) on Day 1.

Also known as: ALXN1720

Gefurulimab AI

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
• Body weight within ≥ 50 to \< 110 kg and body mass index (BMI) within the range 18.5 to 30 kg/m2 (inclusive)
• 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.
• 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.
• Documented vaccination against meningococcal infection from serogroups A, C, W, and Y and serogroup B.
• Male and female participants should adhere to study-specific contraceptive methods.

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.
• Allergy to monoclonal antibodies.
• Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe posttreatment hypersensitivity reactions.
• 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.
• Known hepatic or biliary abnormalities.
• Active systemic bacterial, viral, or fungal infection within 14 days prior to dosing.
• History of allergy or intolerance to penicillin or cephalosporin.
• History of clinically significant allergic reaction (eg, anaphylaxis or angioedema) to any product.
• Live vaccine(s) within 1 month prior to Screening or plans to receive such vaccines during the study.
• 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).

Sponsors & Collaborators

• Alexion Pharmaceuticals, Inc.: lead
• Parexel: collaborator

Study Sites (2)

Research Site

Toronto, Ontario, M9L 3A2, Canada

Location

Research Site

Laval, Quebec, h7v 4bc, Canada

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is an open-label study. To avoid potential bias and maintain the data integrity, the analysis and reporting performed before database lock for Primary Analysis, ie, dry run/blinded data review for Primary Analysis, will be based on blinded data in which the treatment information is based on a dummy randomization schedule.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Separate randomization lists will be produced for each weight stratum (ie, 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 (PFS-SD or AI) and injection site (abdomen, thigh, or upper arm).

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: January 17, 2024
• Study Start: November 22, 2023
• Primary Completion: September 17, 2024
• Study Completion: September 28, 2024
• Last Updated: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPINPhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

CA (2)