Clinical trial NCT05306275: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: CSL Behring
Sponsor class: INDUSTRY
First posted: 2022-04-01
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Maximum plasma concentration (Cmax) of CSL312
timeFrame: Up to 85 days post-dose
measure: Area under the concentration-time curve (AUC) from time 0 extrapolated to infinite time (AUC0-inf) of CSL312
timeFrame: Up to 85 days post-dose
Secondary outcomes:
measure: Number and percentage of subjects experiencing adverse events (AEs)
timeFrame: Up to 85 days post-dose
measure: Number and percentage of subjects experiencing serious adverse events (SAEs)
timeFrame: Up to 85 days post-dose
measure: Number and percentage of subjects experiencing adverse events of special interest (AESIs)
timeFrame: Up to 85 days post-dose
measure: Number and percentage of subjects developing Anti-CSL312 antibodies
timeFrame: Up to 85 days post-dose
measure: Number and percentage of subjects with clinically significant laboratory abnormalities that are reported as AEs
timeFrame: Up to 85 days post-dose
measure: Number and percentage of subjects with injection site reactions by severity
timeFrame: Up to 48 hours post-injection
measure: Time to maximum plasma concentration (Tmax) of CSL312
timeFrame: Up to 85 days post-dose
measure: AUC from time 0 to the last measurable concentration (AUC0-last) of CSL312
timeFrame: Up to 85 days post-dose
measure: Half-life (t1/2) of CSL312
timeFrame: Up to 85 days post-dose
measure: Apparent clearance (CL/F) of CSL312
timeFrame: Up to 85 days post-dose
measure: Apparent volume of distribution (Vz/F) of CSL312
timeFrame: Up to 85 days post-dose
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
Study officials:
affiliation: CSL Behring
name: Study Director
role: STUDY_DIRECTOR
References: