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OpenTrials
Completed

NCT Number: 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

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.

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Key information

Conditions

Healthy Participants

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CSL312

Drug

Factor XIIa antagonist monoclonal antibody for subcutaneous use

Other names: Gardacimab

Primary outcomes

  1. Maximum plasma concentration (Cmax) of CSL312

    Time frame: Up to 85 days post-dose

  2. Area under the concentration-time curve (AUC) from time 0 extrapolated to infinite time (AUC0-inf) of CSL312

    Time frame: Up to 85 days post-dose

Secondary outcomes

  1. Number and percentage of subjects experiencing adverse events (AEs)

    Time frame: Up to 85 days post-dose

  2. Number and percentage of subjects experiencing serious adverse events (SAEs)

    Time frame: Up to 85 days post-dose

  3. Number and percentage of subjects experiencing adverse events of special interest (AESIs)

    Time frame: Up to 85 days post-dose

  4. Number and percentage of subjects developing Anti-CSL312 antibodies

    Time frame: Up to 85 days post-dose

  5. Number and percentage of subjects with clinically significant laboratory abnormalities that are reported as AEs

    Time frame: Up to 85 days post-dose

  6. Number and percentage of subjects with injection site reactions by severity

    Time frame: Up to 48 hours post-injection

  7. Time to maximum plasma concentration (Tmax) of CSL312

    Time frame: Up to 85 days post-dose

  8. AUC from time 0 to the last measurable concentration (AUC0-last) of CSL312

    Time frame: Up to 85 days post-dose

  9. Half-life (t1/2) of CSL312

    Time frame: Up to 85 days post-dose

  10. Apparent clearance (CL/F) of CSL312

    Time frame: Up to 85 days post-dose

  11. Apparent volume of distribution (Vz/F) of CSL312

    Time frame: Up to 85 days post-dose

Sponsors and collaborators

Lead sponsor

CSL Behring

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 1, 2022
Registry last updated
Oct 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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