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

Healthy Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05306275
• Other study ID #: CSL312_1004
• Status: Completed
• Phase: Phase 1
• Start date: April 4, 2022
• Est. completion date: September 27, 2022

Study information

• Verified date: October 2022
• Source: CSL Behring
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: September 27, 2022
• Est. primary completion date: September 27, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• CSL312
Factor XIIa antagonist monoclonal antibody for subcutaneous use

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials, LLC	Anaheim	California

Sponsors (1)

Lead Sponsor	Collaborator
CSL Behring

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum plasma concentration (Cmax) of CSL312		Up to 85 days post-dose
Primary	Area under the concentration-time curve (AUC) from time 0 extrapolated to infinite time (AUC0-inf) of CSL312		Up to 85 days post-dose
Secondary	Number and percentage of subjects experiencing adverse events (AEs)		Up to 85 days post-dose
Secondary	Number and percentage of subjects experiencing serious adverse events (SAEs)		Up to 85 days post-dose
Secondary	Number and percentage of subjects experiencing adverse events of special interest (AESIs)		Up to 85 days post-dose
Secondary	Number and percentage of subjects developing Anti-CSL312 antibodies		Up to 85 days post-dose
Secondary	Number and percentage of subjects with clinically significant laboratory abnormalities that are reported as AEs		Up to 85 days post-dose
Secondary	Number and percentage of subjects with injection site reactions by severity		Up to 48 hours post-injection
Secondary	Time to maximum plasma concentration (Tmax) of CSL312		Up to 85 days post-dose
Secondary	AUC from time 0 to the last measurable concentration (AUC0-last) of CSL312		Up to 85 days post-dose
Secondary	Half-life (t1/2) of CSL312		Up to 85 days post-dose
Secondary	Apparent clearance (CL/F) of CSL312		Up to 85 days post-dose
Secondary	Apparent volume of distribution (Vz/F) of CSL312		Up to 85 days post-dose