NCT06208488

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 175 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Healthy Adult Participants

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-11-22
• Primary completion: 2024-09-17
• Completion: 2024-09-28
• First posted: 2024-01-17
• Last updated: 2024-10-23

Locations

2 sites across 1 country: Canada