Status:
COMPLETED
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
Lead Sponsor:
CSL Behring
Conditions:
Healthy Participants
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 co...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 27 2022
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT05306275
Start Date
April 4 2022
End Date
September 27 2022
Last Update
October 6 2022
Active Locations (1)
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1
Anaheim Clinical Trials, LLC
Anaheim, California, United States, 92801