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 Behring

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: CSL312

Study type: Interventional

Funder types: Industry

Identifiers

NCT05306275

CSL312_1004

Details and patient eligibility

About

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.

Enrollment: 132 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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132 participants in 6 patient groups

CSL312 AI Abdomen

Experimental group

Description:

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

Treatment:

Drug: CSL312

CSL312 AI Thigh

Experimental group

Description:

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

Treatment:

Drug: CSL312

CSL312 AI Arm

Experimental group

Description:

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

Treatment:

Drug: CSL312

CSL312 NSD Abdomen

Experimental group

Description:

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

Treatment:

Drug: CSL312

CSL312 NSD Thigh

Experimental group

Description:

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

Treatment:

Drug: CSL312

CSL312 NSD Arm

Experimental group

Description:

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

Treatment:

Drug: CSL312