To Assess the Safety and Tolerability of MTx-COVAB36 as a Therapeutic and Prophylactic Treatment Against COVID-19.
Condition: SARS-CoV-2 Infection
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): MTx-COVAB36; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 0.9% saline
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single-blind, placebo-controlled study in healthy volunteers. 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 predefined investigational medicinal product (IMP) doses are: 100 mg, 500 mg, 1,000 mg and 2,000 mg, respectively. Participants will be randomized into study arms (MTx-COVAB36 or placebo).
Masking: Single (Participant)
Primary purpose: Treatment