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

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 Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: CSL312

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CSL312 AI Abdomen; CSL312 administered subcutaneously (SC) in the abdomen via a prefilled syringe assembled to an autoinjector (AI)	Drug: CSL312; Factor XIIa antagonist monoclonal antibody for subcutaneous use; Other Names: Gardacimab
EXPERIMENTAL: CSL312 AI Thigh; CSL312 administered SC in the thigh via a prefilled syringe assembled to an AI	Drug: CSL312; Factor XIIa antagonist monoclonal antibody for subcutaneous use; Other Names: Gardacimab
EXPERIMENTAL: CSL312 AI Arm; CSL312 administered SC in the upper arm via a prefilled syringe assembled to an AI	Drug: CSL312; Factor XIIa antagonist monoclonal antibody for subcutaneous use; Other Names: Gardacimab
EXPERIMENTAL: CSL312 NSD Abdomen; CSL312 administered SC in the abdomen via a prefilled syringe assembled to a needle safety device (NSD)	Drug: CSL312; Factor XIIa antagonist monoclonal antibody for subcutaneous use; Other Names: Gardacimab
EXPERIMENTAL: CSL312 NSD Thigh; CSL312 administered SC in the thigh via a prefilled syringe assembled to a NSD	Drug: CSL312; Factor XIIa antagonist monoclonal antibody for subcutaneous use; Other Names: Gardacimab
EXPERIMENTAL: CSL312 NSD Arm; CSL312 administered SC in the upper arm via a prefilled syringe assembled to a NSD	Drug: CSL312; Factor XIIa antagonist monoclonal antibody for subcutaneous use; Other Names: Gardacimab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Number and percentage of subjects experiencing adverse events (AEs)	Up to 85 days post-dose
Number and percentage of subjects experiencing serious adverse events (SAEs)	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 developing Anti-CSL312 antibodies	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
Number and percentage of subjects with injection site reactions by severity	Up to 48 hours post-injection
Time to maximum plasma concentration (Tmax) of CSL312	Up to 85 days post-dose
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
Apparent clearance (CL/F) of CSL312	Up to 85 days post-dose
Apparent volume of distribution (Vz/F) of CSL312	Up to 85 days post-dose

Collaborators and Investigators

• Sponsor: CSL Behring

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 4, 2022
• Primary Completion (ACTUAL): September 27, 2022
• Study Completion (ACTUAL): September 27, 2022

Study Registration Dates

• First Submitted: March 23, 2022
• First Submitted That Met QC Criteria: March 23, 2022
• First Posted (ACTUAL): April 1, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 6, 2022
• Last Update Submitted That Met QC Criteria: October 5, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CSL312_1004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.
• IPD Sharing Time Frame: Requests for IPD will generally be considered once review by major regulatory authorities (ie FDA, EMA) is complete and the primary publication is available.

IPD Sharing Access Criteria

Proposed research should seek to answer a previously unanswered important medical or scientific question.

Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.

If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No