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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04638634




Registration number
NCT04638634
Ethics application status
Date submitted
19/11/2020
Date registered
20/11/2020

Titles & IDs
Public title
Pharmacokinetics, Safety, and Tolerability of CSL760, an Intravenous Anti-SARS-CoV-2 Hyperimmune Globulin, in Healthy Adult Subjects
Scientific title
A Single Center, Phase 1, Single-Ascending Dose, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of CSL760, an Intravenous Anti-SARS-CoV-2 Hyperimmune Globulin, in Healthy Adult Subjects
Secondary ID [1] 0 0
CSL760_1001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronavirus Disease 2019 (COVID-19) 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - CSL760

Experimental: CSL760 (low dose) - Administered as an intravenous infusion

Experimental: CSL760 (high dose) - Administered as an intravenous infusion


Treatment: Other: CSL760
An Intravenous Anti-SARS-CoV-2 Hyperimmune Globulin
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Total immunoglobulin (IgG) concentration of CSL760
Timepoint [1] 0 0
At 0,0.5,1,2,6,12,24, and 48 hours, and 7,14,28,49, and 91 days after end of IV infusion
Primary outcome [2] 0 0
Maximum concentration (Cmax) of CSL760
Timepoint [2] 0 0
Up to 91 days after end of IV infusion
Primary outcome [3] 0 0
Time of Cmax (tmax) of CSL760
Timepoint [3] 0 0
Up to 91 days after end of IV infusion
Primary outcome [4] 0 0
Area under the concentration-time curve (AUC) from time 0 to the last measurable concentration (AUC0-last) of CSL760
Timepoint [4] 0 0
Up to 91 days after end of IV infusion
Secondary outcome [1] 0 0
Number of subjects with Treatment-emergent adverse events (TEAEs)
Timepoint [1] 0 0
From start of infusion up to 91 days
Secondary outcome [2] 0 0
Percent of subjects with TEAEs
Timepoint [2] 0 0
From start of infusion up to 91 days
Secondary outcome [3] 0 0
Number of subjects with Serious adverse events (SAEs)
Timepoint [3] 0 0
From start of infusion up to 91 days
Secondary outcome [4] 0 0
Percent of subjects with SAEs
Timepoint [4] 0 0
From start of infusion up to 91 days
Secondary outcome [5] 0 0
Number of subjects with Clinically significant laboratory abnormalities that are reported as adverse events (AEs)
Timepoint [5] 0 0
From start of infusion up to 91 days
Secondary outcome [6] 0 0
Percent of subjects with Clinically significant laboratory abnormalities that are reported as AEs
Timepoint [6] 0 0
From start of infusion up to 91 days

Eligibility
Key inclusion criteria
* Male or female 18 to 65 years of age
* Female subjects must be postmenopausal or have a negative pregnancy test
* Body weight in the range of = 50 kg and = 100 kg and have a body mass index of = 18 to = 32 kg/m2
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* History of acute or chronic renal failure, thromboembolism, chronic respiratory illness, aseptic meningitis syndrome, or recurrent severe headaches or migraines.
* Positive viral serology test for HIV -1/2 antibody, hepatitis B virus surface antigen, or hepatitis C virus antibody
* Positive viral serology test for SARS-CoV-2 antibodies
* Received any live viral or bacterial vaccinations within 8 weeks
* Evidence of current active infection.
* Known malignancy or a history of malignancy in the past 5 years
* Female subject of childbearing potential or fertile male subject either not using or not willing to use an acceptable double barrier method of contraception to avoid pregnancy during the study

Study design
Purpose of the study
Other
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/02/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/06/2021
Sample size
Target
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
CMAX Clinical Research - Adelaide
Recruitment postcode(s) [1] 0 0
SA 5000 - Adelaide

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 Innovation Pty Ltd
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/NCT04638634