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

NCT05306275 | Completed Phase 1 FDA Drug

• 1 other identifier: CSL312_1004
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• 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

Study Arms (6)

CSL312 AI Abdomen

EXPERIMENTAL

CSL312 administered subcutaneously (SC) in the abdomen via a prefilled syringe assembled to an autoinjector (AI)

Drug: CSL312

CSL312 AI Thigh

EXPERIMENTAL

CSL312 administered SC in the thigh via a prefilled syringe assembled to an AI

Drug: CSL312

CSL312 AI Arm

EXPERIMENTAL

CSL312 administered SC in the upper arm via a prefilled syringe assembled to an AI

Drug: CSL312

CSL312 NSD Abdomen

EXPERIMENTAL

CSL312 administered SC in the abdomen via a prefilled syringe assembled to a needle safety device (NSD)

Drug: CSL312

CSL312 NSD Thigh

EXPERIMENTAL

CSL312 administered SC in the thigh via a prefilled syringe assembled to a NSD

Drug: CSL312

CSL312 NSD Arm

EXPERIMENTAL

CSL312 administered SC in the upper arm via a prefilled syringe assembled to a NSD

Drug: CSL312

Interventions

CSL312 DRUG

Factor XIIa antagonist monoclonal antibody for subcutaneous use

Also known as: Gardacimab

CSL312 AI Abdomen; CSL312 AI Arm; CSL312 AI Thigh; CSL312 NSD Abdomen; CSL312 NSD Arm; CSL312 NSD Thigh

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CSL Behring: lead

Study Sites (1)

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

Study Officials

• Study Director

  CSL Behring

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 1, 2022
• Study Start: April 4, 2022
• Primary Completion: September 27, 2022
• Study Completion: September 27, 2022
• Last Updated: October 6, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

US (1)