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

NCT04570267 | Completed Phase 1

• 1 other identifier: CSL324_1003
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Maximum concentration (Cmax) of CSL324 in serum

  From Day 1 to Day 56

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

  From Day 1 to Day 56

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

  From Day 1 to Day 56

Secondary Outcomes (10)

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

  Up to Day 56

• Percentage of subjects with TEAEs by incidence, by severity, and by causality

  Up to Day 56

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

  Up to Day 7

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

  Up to Day 7

• Time to reach Cmax (Tmax) for CSL324 in serum

  From Day 1 to Day 56

Study Arms (3)

CSL324 (Low dose)

EXPERIMENTAL

One low dose of CSL324 administered subcutaneously on Day 1

Biological: CSL324

CSL324 (High dose)

EXPERIMENTAL

One high dose of CSL324 administered subcutaneously on Day 1

Biological: CSL324

Placebo

PLACEBO COMPARATOR

One dose of placebo administered subcutaneously on Day 1

Drug: Placebo

Interventions

CSL324 BIOLOGICAL

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

Also known as: Recombinant Anti G-CSF Receptor Monoclonal Antibody

CSL324 (High dose); CSL324 (Low dose)

Placebo DRUG

Sterile solution of CSL324 formulation buffer for injection

Placebo

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• CSL Behring: lead

Study Sites (1)

Scientia Clinical Research Ltd

Randwick, Australia

Location

Study Officials

• Study Director

  CSL Behring

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2020
• First Posted: September 30, 2020
• Study Start: October 8, 2020
• Primary Completion: November 17, 2021
• Study Completion: December 9, 2021
• Last Updated: October 4, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: IPD requests may be submitted to CSL no earlier than 12 months after publication of the results of this study via an article made available on a public website.
• Access Criteria: Requests may only be made by systematic review groups or bona-fide researchers whose proposed use of the IPD is non-commercial in nature and has been approved by an internal review committee. An IPD request will not be considered by CSL unless the proposed research question seeks to answer a significant and unknown medical science or patient care question as determined by CSL's internal review committee. The requesting party must execute an appropriate data sharing agreement before IPD will be made available.

Locations

AU (1)