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

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 Overview

• Status: Terminated
• Conditions: Coronavirus Disease 2019 (COVID-19)
• Intervention / Treatment: Biological: CSL760

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Adelaide, Australia, SA 5000
    • CMAX Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NON_RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CSL760 (low dose); Administered as an intravenous infusion	Biological: CSL760; An Intravenous Anti-SARS-CoV-2 Hyperimmune Globulin; Other Names: COVID-19 Immunoglobulin-VF
EXPERIMENTAL: CSL760 (high dose); Administered as an intravenous infusion	Biological: CSL760; An Intravenous Anti-SARS-CoV-2 Hyperimmune Globulin; Other Names: COVID-19 Immunoglobulin-VF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Percent of subjects with Clinically significant laboratory abnormalities that are reported as AEs	From start of infusion up to 91 days

Collaborators and Investigators

• Sponsor: CSL Behring
• Investigators: Study Director: Study Director, CSL Innovation Pty Ltd

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 2, 2021
• Primary Completion (ACTUAL): June 9, 2021
• Study Completion (ACTUAL): June 9, 2021

Study Registration Dates

• First Submitted: November 19, 2020
• First Submitted That Met QC Criteria: November 19, 2020
• First Posted (ACTUAL): November 20, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 10, 2021
• Last Update Submitted That Met QC Criteria: December 9, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Immunologic Factors; Immunoglobulins
• Other Study ID Numbers: CSL760_1001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing 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.

IPD Sharing 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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No