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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04570267




Registration number
NCT04570267
Ethics application status
Date submitted
25/09/2020
Date registered
30/09/2020

Titles & IDs
Public title
Pharmacokinetics and Safety of Subcutaneous CSL324 in Healthy Japanese and White Subjects
Scientific 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
Secondary ID [1] 0 0
CSL324_1003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - CSL324
Treatment: Drugs - Placebo

Experimental: CSL324 (Low dose) - One low dose of CSL324 administered subcutaneously on Day 1

Experimental: CSL324 (High dose) - One high dose of CSL324 administered subcutaneously on Day 1

Placebo comparator: Placebo - One dose of placebo administered subcutaneously on Day 1


Treatment: Other: CSL324
Sterile solution of recombinant anti G-CSF receptor monoclonal antibody for injection

Treatment: Drugs: Placebo
Sterile solution of CSL324 formulation buffer for injection
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maximum concentration (Cmax) of CSL324 in serum
Timepoint [1] 0 0
From Day 1 to Day 56
Primary outcome [2] 0 0
Area under the concentration-time curve from time 0 extrapolated to time infinity (AUC0-inf) of CSL324 in serum
Timepoint [2] 0 0
From Day 1 to Day 56
Primary outcome [3] 0 0
Area under the concentration-time curve from time 0 to the last measurable concentration (AUC0-last) of CSL324 in serum
Timepoint [3] 0 0
From Day 1 to Day 56
Secondary outcome [1] 0 0
Number of subjects with treatment-emergent adverse events (TEAEs) by incidence, by severity, and by causality
Timepoint [1] 0 0
Up to Day 56
Secondary outcome [2] 0 0
Percentage of subjects with TEAEs by incidence, by severity, and by causality
Timepoint [2] 0 0
Up to Day 56
Secondary outcome [3] 0 0
Number of subjects with adverse events localized to the administration site by incidence, by severity, and by causality
Timepoint [3] 0 0
Up to Day 7
Secondary outcome [4] 0 0
Percentage of subjects with adverse events localized to the administration site by incidence, by severity, and by causality
Timepoint [4] 0 0
Up to Day 7
Secondary outcome [5] 0 0
Time to reach Cmax (Tmax) for CSL324 in serum
Timepoint [5] 0 0
From Day 1 to Day 56
Secondary outcome [6] 0 0
Terminal half-life (t1/2) for CSL324 in serum
Timepoint [6] 0 0
From Day 1 to Day 56
Secondary outcome [7] 0 0
Apparent clearance (CL/F) for CSL324 in serum
Timepoint [7] 0 0
From Day 1 to Day 56
Secondary outcome [8] 0 0
Apparent volume of distribution (Vz/F) for CSL324 in serum
Timepoint [8] 0 0
From Day 1 to Day 56
Secondary outcome [9] 0 0
Number of subjects with or without anti-CSL324 antibodies
Timepoint [9] 0 0
Up to Day 56
Secondary outcome [10] 0 0
Percentage of subjects with or without anti-CSL324 antibodies
Timepoint [10] 0 0
Up to Day 56

Eligibility
Key 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
Minimum age
20 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/12/2021
Sample size
Target
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Scientia Clinical Research Ltd - Randwick
Recruitment postcode(s) [1] 0 0
- Randwick

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
CSL Behring
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
CSL Behring
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
CSL will consider requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at [email protected].

Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.

If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04570267