Clinical trial NCT04638634: Pharmacokinetics, Safety, and Tolerability of CSL760, an Intravenous Anti-SARS-CoV-2 Hyperimmune Globulin, in Healthy Adult Subjects
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Coronavirus Disease 2019 (COVID-19)
Lead sponsor: CSL Behring
Sponsor class: INDUSTRY
First posted: 2020-11-20
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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).


Eligibility criteria: 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

Primary outcomes:
measure: Total immunoglobulin (IgG) concentration of CSL760
timeFrame: 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
measure: Maximum concentration (Cmax) of CSL760
timeFrame: Up to 91 days after end of IV infusion
measure: Time of Cmax (tmax) of CSL760
timeFrame: Up to 91 days after end of IV infusion
measure: Area under the concentration-time curve (AUC) from time 0 to the last measurable concentration (AUC0-last) of CSL760
timeFrame: Up to 91 days after end of IV infusion
Secondary outcomes:
measure: Number of subjects with Treatment-emergent adverse events (TEAEs)
timeFrame: From start of infusion up to 91 days
measure: Percent of subjects with TEAEs
timeFrame: From start of infusion up to 91 days
measure: Number of subjects with Serious adverse events (SAEs)
timeFrame: From start of infusion up to 91 days
measure: Percent of subjects with SAEs
timeFrame: From start of infusion up to 91 days
measure: Number of subjects with Clinically significant laboratory abnormalities that are reported as adverse events (AEs)
timeFrame: From start of infusion up to 91 days
measure: Percent of subjects with Clinically significant laboratory abnormalities that are reported as AEs
timeFrame: From start of infusion up to 91 days
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: CMAX Clinical Research
Study officials:
affiliation: CSL Innovation Pty Ltd
name: Study Director
role: STUDY_DIRECTOR
References: