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

Phase 1

Completed

• Conditions: Healthy Participants
• Interventions: Drug: CSL312

• Registration Number: NCT05306275
• Lead Sponsor: CSL Behring

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-23
• Study First Submitted QC: 2022-03-23
• Study First Posted: 2022-04-01
• Study Start: 2022-04-04
• Primary Completion: 2022-09-27
• Study Completion: 2022-09-27
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-05
• Last Update Posted: 2022-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CSL312 AI Abdomen	CSL312	CSL312 administered subcutaneously (SC) in the abdomen via a prefilled syringe assembled to an autoinjector (AI)
CSL312 NSD Thigh	CSL312	CSL312 administered SC in the thigh via a prefilled syringe assembled to a NSD
CSL312 AI Thigh	CSL312	CSL312 administered SC in the thigh via a prefilled syringe assembled to an AI
CSL312 NSD Arm	CSL312	CSL312 administered SC in the upper arm via a prefilled syringe assembled to a NSD
CSL312 AI Arm	CSL312	CSL312 administered SC in the upper arm via a prefilled syringe assembled to an AI
CSL312 NSD Abdomen	CSL312	CSL312 administered SC in the abdomen via a prefilled syringe assembled to a needle safety device (NSD)

Primary Outcome Measures

Name	Time	Method
Maximum plasma concentration (Cmax) of CSL312	Up to 85 days post-dose
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 Outcome Measures

Name	Time	Method
Number and percentage of subjects experiencing adverse events (AEs)	Up to 85 days post-dose
Number and percentage of subjects experiencing adverse events of special interest (AESIs)	Up to 85 days post-dose
Number and percentage of subjects with clinically significant laboratory abnormalities that are reported as AEs	Up to 85 days post-dose
Apparent volume of distribution (Vz/F) of CSL312	Up to 85 days post-dose
Number and percentage of subjects experiencing serious adverse events (SAEs)	Up to 85 days post-dose
Time to maximum plasma concentration (Tmax) of CSL312	Up to 85 days post-dose
Apparent clearance (CL/F) of CSL312	Up to 85 days post-dose
Number and percentage of subjects developing Anti-CSL312 antibodies	Up to 85 days post-dose
Number and percentage of subjects with injection site reactions by severity	Up to 48 hours post-injection
AUC from time 0 to the last measurable concentration (AUC0-last) of CSL312	Up to 85 days post-dose
Half-life (t1/2) of CSL312	Up to 85 days post-dose

Trial Locations

Locations (1)

Anaheim Clinical Trials, LLC; 🇺🇸 Anaheim, California, United States