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Pharmacokinetics, Safety, and Tolerability of CSL760, an Intravenous Anti-SARS-CoV-2 Hyperimmune Globulin, in Healthy Adult Subjects

NCT ID: NCT04638634

Last Updated: 2021-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-02

Study Completion Date

2021-06-09

Brief Summary

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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).

Detailed Description

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Conditions

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Coronavirus Disease 2019 (COVID-19)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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CSL760 (low dose)

Administered as an intravenous infusion

Group Type EXPERIMENTAL

CSL760

Intervention Type BIOLOGICAL

An Intravenous Anti-SARS-CoV-2 Hyperimmune Globulin

CSL760 (high dose)

Administered as an intravenous infusion

Group Type EXPERIMENTAL

CSL760

Intervention Type BIOLOGICAL

An Intravenous Anti-SARS-CoV-2 Hyperimmune Globulin

Interventions

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CSL760

An Intravenous Anti-SARS-CoV-2 Hyperimmune Globulin

Intervention Type BIOLOGICAL

Other Intervention Names

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COVID-19 Immunoglobulin-VF

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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CSL Behring

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

CSL Innovation Pty Ltd

Locations

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CMAX Clinical Research

Adelaide, , Australia

Site Status

Countries

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Australia

Other Identifiers

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CSL760_1001

Identifier Type: -

Identifier Source: org_study_id