Healthy Participants

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 | PHASE 1 | INTERVENTIONAL

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.

1 Sites

132 Participants

Recruiting

18 Years to 55 Years

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SUBMIT

Anaheim Clinical Trials, LLC

Anaheim,California,United States,92801

Study 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

Additional Studies

Additional studies can be found at ClinicalTrials.gov