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

NCT06208488 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2024-10-23

No results posted yet for this study

Summary

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

Conditions

  • Healthy Adult Participants

Interventions

DRUG

Gefurulimab PFS-SD

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

DRUG

Gefurulimab AI

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

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • Alexion Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-22
Primary Completion
2024-09-17
Completion
2024-09-28

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06208488 on ClinicalTrials.gov