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A phase I/II a double-blind, randomized, placebo-controlled, dose-finding study to evaluate the safety, dose, route of administration, immunogenicity and affect of ISR's spike-based inhalation / nasal vaccine formulations in healthy subjects

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Trial Profile

A phase I/II a double-blind, randomized, placebo-controlled, dose-finding study to evaluate the safety, dose, route of administration, immunogenicity and affect of ISR's spike-based inhalation / nasal vaccine formulations in healthy subjects

Status: Planning
Phase of Trial: Phase I/II

Latest Information Update: 07 Jul 2022

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At a glance

  • Drugs ISR 52 (Primary)
  • Indications COVID 2019 infections
  • Focus Adverse reactions; First in man; Therapeutic Use

    • Most Recent Events

    • 01 Jul 2022 According to an ISR media release, company has received approval from BMRC NREC for this trial in Bangladesh.
    • 02 Jun 2022 According to Immune System Regulation media release, the company has conducted an audit of the clinical trial center, the clinical laboratory and our CRO, which will be responsible for the operational operation and implementation of the clinical study.
    • 21 Feb 2022 According to Immune System Regulation media release, the company has submitted an application to the Bangladesh Medical Research Council (BMRC) to lead the approval process for conducting a Phase I / II study with ISR52 nasal dry powder vaccine against SARS CoV-2.

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