Study Stopped
For business reasons, not a safety issue
Pharmacokinetics, Safety, and Tolerability of CSL760, an Intravenous Anti-SARS-CoV-2 Hyperimmune Globulin, in Healthy Adult Subjects
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
1 other identifier
interventional
12
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Feb 2021
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2020
CompletedFirst Posted
Study publicly available on registry
November 20, 2020
CompletedStudy Start
First participant enrolled
February 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 9, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 9, 2021
CompletedDecember 10, 2021
December 1, 2021
4 months
November 19, 2020
December 9, 2021
Conditions
Outcome Measures
Primary Outcomes (4)
Total immunoglobulin (IgG) concentration of CSL760
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
Up to 91 days after end of IV infusion
Time of Cmax (tmax) of CSL760
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
Up to 91 days after end of IV infusion
Secondary Outcomes (6)
Number of subjects with Treatment-emergent adverse events (TEAEs)
From start of infusion up to 91 days
Percent of subjects with TEAEs
From start of infusion up to 91 days
Number of subjects with Serious adverse events (SAEs)
From start of infusion up to 91 days
Percent of subjects with SAEs
From start of infusion up to 91 days
Number of subjects with Clinically significant laboratory abnormalities that are reported as adverse events (AEs)
From start of infusion up to 91 days
- +1 more secondary outcomes
Study Arms (2)
CSL760 (low dose)
EXPERIMENTALAdministered as an intravenous infusion
CSL760 (high dose)
EXPERIMENTALAdministered as an intravenous infusion
Interventions
An Intravenous Anti-SARS-CoV-2 Hyperimmune Globulin
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CSL Behringlead
Study Sites (1)
CMAX Clinical Research
Adelaide, SA 5000, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
CSL Innovation Pty Ltd
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2020
First Posted
November 20, 2020
Study Start
February 2, 2021
Primary Completion
June 9, 2021
Study Completion
June 9, 2021
Last Updated
December 10, 2021
Record last verified: 2021-12
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.
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.