NCT05306275

A Study to Compare the Pharmacokinetics of CSL312 Administered by Prefilled Syringe Assembled to Autoinjector to the Pharmacokinetics Administered by Prefilled Syringe Assembled to Needle Safety Device in Healthy Subjects

A Phase 1, Randomized, Open-label, Parallel-group Study to Compare the Pharmacokinetic Properties of CSL312 Administered by Subcutaneous Prefilled Syringe Assembled to Autoinjector to Prefilled Syringe Assembled to Needle Safety Device in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: CSL Behring · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, parallel-group, phase 1, single center study to assess the relative bioavailability of CSL312 administered subcutaneously via a prefilled syringe assembled to an autoinjector compared to a prefilled syringe assembled to a needle safety device in healthy, adult subjects.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	CSL312	Factor XIIa antagonist monoclonal antibody for subcutaneous use

Timeline

• Start date: 2022-04-04
• Primary completion: 2022-09-27
• Completion: 2022-09-27
• First posted: 2022-04-01
• Last updated: 2022-10-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study