Coronavirus Disease 2019 (COVID-19)Phase 1NCT04638634
Pharmacokinetics, Safety, and Tolerability of CSL760, an Intravenous Anti-SARS-CoV-2 Hyperimmune Globulin, in Healthy Adult Subjects
A Phase 1 study testing CSL760 in people with Coronavirus Disease 2019 (COVID-19), run by CSL Behring at 1 site in Australia.
Trial summary
CSL760 is a human hyperimmune product of the purified gamma immunoglobulin (IgG) fraction of human plasma containing polyvalent neutralizing antibodies to SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). CSL is evaluating CSL760 as a passive immunotherapy for COVID-19 (Coronavirus Disease 2019). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronavirus Disease 2019 (COVID-19)
- What is being tested?
- CSL760
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteAustralia
- Study dates
- 2 Feb 2021to 9 Jun 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
CSL760 is a human hyperimmune product of the purified gamma immunoglobulin (IgG) fraction of human plasma containing polyvalent neutralizing antibodies to SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). CSL is evaluating CSL760 as a passive immunotherapy for COVID-19 (Coronavirus Disease 2019).
- Conditions
- Coronavirus Disease 2019 (COVID-19)
- Being tested
- CSL760
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSL760Biological
Also called COVID-19 Immunoglobulin-VF
An Intravenous Anti-SARS-CoV-2 Hyperimmune Globulin
| Study group | Role | What they receive |
|---|---|---|
| CSL760 (low dose) | Experimental | Administered as an intravenous infusion Receives: Biological: CSL760 |
| CSL760 (high dose) | Experimental | Administered as an intravenous infusion Receives: Biological: CSL760 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total immunoglobulin (IgG) concentration of CSL760
Measured: 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
Maximum concentration (Cmax) of CSL760
Measured: Up to 91 days after end of IV infusion
Time of Cmax (tmax) of CSL760
Measured: Up to 91 days after end of IV infusion
Area under the concentration-time curve (AUC) from time 0 to the last measurable concentration (AUC0-last) of CSL760
Measured: Up to 91 days after end of IV infusion
Secondary outcomes (6)
Number of subjects with Treatment-emergent adverse events (TEAEs)
Measured: From start of infusion up to 91 days
Percent of subjects with TEAEs
Measured: From start of infusion up to 91 days
Number of subjects with Serious adverse events (SAEs)
Measured: From start of infusion up to 91 days
Percent of subjects with SAEs
Measured: From start of infusion up to 91 days
Number of subjects with Clinically significant laboratory abnormalities that are reported as adverse events (AEs)
Measured: From start of infusion up to 91 days
Percent of subjects with Clinically significant laboratory abnormalities that are reported as AEs
Measured: From start of infusion up to 91 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start2 Feb 2021
- Primary completion9 Jun 2021
- Study completion9 Jun 2021
Why it stopped: For business reasons, not a safety issue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus Disease 2019 (COVID-19)Studies of the same condition, open and under way.
- More trials run by CSL BehringThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSL Behring
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, CSL Innovation Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04638634
- Sponsor's protocol ID
- CSL760_1001
- Status last verified
- Dec 2021
- First submitted
- 19 Nov 2020
- Last updated
- 10 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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 clinicaltrials@cslbehring.com. 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04638634
- Acronym / sponsor ID
- CSL760_1001
- Conditions
- Coronavirus Disease 2019 (COVID-19)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: For business reasons, not a safety issue
- Enrolment
- 12 participants (actual)
- Lead sponsor
- CSL BehringIndustry (pharma, biotech, devices)
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- 9 Jun 2021 (actual)
- Study completion
- 9 Jun 2021 (actual)
- First posted
- 20 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CSL760 is a human hyperimmune product of the purified gamma immunoglobulin (IgG) fraction of human plasma containing polyvalent neutralizing antibodies to SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). CSL is evaluating CSL760 as a passive immunotherapy for COVID-19 (Coronavirus Disease 2019).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CSL760 (low dose) | Experimental | Biological: CSL760Administered as an intravenous infusion |
| CSL760 (high dose) | Experimental | Biological: CSL760Administered as an intravenous infusion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CSL760Also: COVID-19 Immunoglobulin-VFAn Intravenous Anti-SARS-CoV-2 Hyperimmune Globulin | Biological | CSL760 (high dose), CSL760 (low dose) |
Primary outcome
Total immunoglobulin (IgG) concentration of CSL760
Time frame: 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
Maximum concentration (Cmax) of CSL760
Time frame: Up to 91 days after end of IV infusion
Time of Cmax (tmax) of CSL760
Time frame: Up to 91 days after end of IV infusion
Area under the concentration-time curve (AUC) from time 0 to the last measurable concentration (AUC0-last) of CSL760
Time frame: Up to 91 days after end of IV infusion
6 secondary outcomes
Number of subjects with Treatment-emergent adverse events (TEAEs)
Time frame: From start of infusion up to 91 days
Percent of subjects with TEAEs
Time frame: From start of infusion up to 91 days
Number of subjects with Serious adverse events (SAEs)
Time frame: From start of infusion up to 91 days
Percent of subjects with SAEs
Time frame: From start of infusion up to 91 days
Number of subjects with Clinically significant laboratory abnormalities that are reported as adverse events (AEs)
Time frame: From start of infusion up to 91 days
Percent of subjects with Clinically significant laboratory abnormalities that are reported as AEs
Time frame: From start of infusion up to 91 days
Results and safety
The study was stopped early (reason given: For business reasons, not a safety issue). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
- Individual participant dataSharing planned: Yes. 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 clinicaltrials@cslbehring.com. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
CSL Innovation Pty Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CSL760 in people with Coronavirus Disease 2019 (COVID-19), run by CSL Behring at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: For business reasons, not a safety issue). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total immunoglobulin (IgG) concentration of CSL760 (time frame: 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2021.