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Completed

NCT Number: NCT04570267

Pharmacokinetics and Safety of Subcutaneous CSL324 in Healthy Japanese and White Subjects

Study CSL324_1003 is a single center, randomized, double-blind, placebo-controlled study designed to characterize and compare the PK properties and safety of a single subcutaneous dose of CSL324 in healthy Japanese and White subjects.

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Key information

Conditions

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Scientia Clinical Research Ltd

Randwick, Australia

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male or female Japanese or White subjects aged 20 and 55 years, inclusive
  • Body weight of at least 45 kg to 100 kg, inclusive
  • Body mass index of 18.0 to 32.0 kg/m2, inclusive

Exclusion criteria

  • A clinically significant medical condition, disorder, or disease of any organ system.
  • Concurrent diagnosis of malignancy or history of malignancy (except for nonmelanoma skin cancer or cervical carcinoma in situ that has been adequately treated with no evidence of recurrence for at least 3 months before Screening).
  • Immunosuppressive conditions and / or currently taking immunosuppressive or immunomodulative therapy.
  • Clinically significant abnormalities on physical examination, vital signs, or laboratory assessments, or neutropenia (defined as absolute neutrophil count < 2.0 × 109/L).
  • History of chronic or recurrent infections, clinical signs of active infection and / or fever, current / history of serious infection or hospitalized or received IV antibiotics for an infection in previous 2 months.

Treatment and study plan

CSL324

Biological

Sterile solution of recombinant anti G-CSF receptor monoclonal antibody for injection

Other names: Recombinant Anti G-CSF Receptor Monoclonal Antibody

Placebo

Drug

Sterile solution of CSL324 formulation buffer for injection

Primary outcomes

  1. Maximum concentration (Cmax) of CSL324 in serum

    Time frame: From Day 1 to Day 56

  2. Area under the concentration-time curve from time 0 extrapolated to time infinity (AUC0-inf) of CSL324 in serum

    Time frame: From Day 1 to Day 56

  3. Area under the concentration-time curve from time 0 to the last measurable concentration (AUC0-last) of CSL324 in serum

    Time frame: From Day 1 to Day 56

Secondary outcomes

  1. Number of subjects with treatment-emergent adverse events (TEAEs) by incidence, by severity, and by causality

    Time frame: Up to Day 56

  2. Percentage of subjects with TEAEs by incidence, by severity, and by causality

    Time frame: Up to Day 56

  3. Number of subjects with adverse events localized to the administration site by incidence, by severity, and by causality

    Time frame: Up to Day 7

  4. Percentage of subjects with adverse events localized to the administration site by incidence, by severity, and by causality

    Time frame: Up to Day 7

  5. Time to reach Cmax (Tmax) for CSL324 in serum

    Time frame: From Day 1 to Day 56

  6. Terminal half-life (t1/2) for CSL324 in serum

    Time frame: From Day 1 to Day 56

  7. Apparent clearance (CL/F) for CSL324 in serum

    Time frame: From Day 1 to Day 56

  8. Apparent volume of distribution (Vz/F) for CSL324 in serum

    Time frame: From Day 1 to Day 56

  9. Number of subjects with or without anti-CSL324 antibodies

    Time frame: Up to Day 56

  10. Percentage of subjects with or without anti-CSL324 antibodies

    Time frame: Up to Day 56

Sponsors and collaborators

Lead sponsor

CSL Behring

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous CSL324 in Healthy Japanese and White Subjects

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 30, 2020
Registry last updated
Oct 4, 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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