SARS-CoV-2 Infection Clinical Trial
Official title:
A Phase l, Single-blind, Placebo-controlled Trial Designed to Assess the Safety and Tolerability of a Single Intravenous Dose of MTx-COVAB36 in Healthy Volunteers.
This is a single blind, placebo-controlled clinical trial designed to determine the safety and tolerability of MTx-COVAB36 after a single administration in a dose escalation, dose limiting toxicity (DLT)-driven approach in healthy volunteers. Additional data to define the recommended phase II dose (RP2D) will also be determined. MTx-COVAB36 is a fully human monoclonal IgG1 antibody derived from the memory B cells of convalescent COVID-19 donors and directed against SARS-CoV-2 spike protein with potent virus neutralising activity. The trial will comprise four dose cohorts, each composed of 6 participants receiving MTx-COVAB36 and 2 participants receiving placebo, with pre-defined dose levels. The pre-defined investigational medicinal product (IMP) doses are: 100 mg, 500 mg, 1,000 mg and 2,000 mg, respectively. Participants will be administered a single dose of either IMP or placebo on Day 1 of the study and will be followed up until 63 days post administration.
Despite the rapid rollout of vaccines against the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), there is still a need for therapeutic and prophylactic treatments against the Coronavirus Disease 2019 (COVID-19) especially for those individuals who are not sufficiently protected by vaccines, i.e., a significant proportion of people of older age, the immunocompromised and those having various comorbidities. MTx-COVAB36 is a fully human monoclonal IgG1 antibody derived from the memory B cells of convalescent COVID-19 donors and directed against SARS-CoV-2 spike protein with potent virus neutralising activity. This is a single blind, placebo-controlled clinical trial designed to determine the safety and tolerability of MTx-COVAB36 after a single administration in a dose escalation, DLT-driven approach in healthy volunteers. Additional data to define the RP2D will also be determined. The trial will comprise four dose cohorts, each composed of 6 participants receiving MTx-COVAB36 and 2 participants receiving placebo, with pre-defined dose levels. The pre-defined IMP doses are: 100 mg, 500 mg, 1,000 mg and 2,000 mg, respectively. Participants will be administered a single dose of either IMP or placebo on Day 1 of the study and will be followed up until 63 days post administration. ;
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