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

CSL Behring132 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

132

Conditions

Healthy Participants

Interventions

CSL312DRUG

Factor XIIa antagonist monoclonal antibody for subcutaneous use

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy Male or female 18 to 55 years of age * Body weight in the range of ≥ 50 kg and ≤ 100 kg, with a body mass index (BMI) of ≥ 18 kg/m2 and ≤ 30 kg/m2 Exclusion Criteria: * Received any live viral or bacterial vaccinations within 8 weeks of Screening or is expected to receive any live virus or bacterial vaccinations during the study or up to 4 months after last administration of the investigational product. * Evidence of current active infection, including severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). * Blood pressure or pulse rate measurements outside the normal range for the subject's age

Locations (1)

Anaheim Clinical Trials, LLC

Anaheim, California, United States