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Safety, Tolerability and Immunogenic Response of CV-MG01 in Patients With Myasthenia Gravis

Myasthenia Gravis Clinical Trial

Official title:
A First-in-human and Proof-of-concept Study to Assess the Safety, Tolerability and Immunogenic Response of CV-MG01, Acetylcholine Receptor Mimetic Peptides, as Potential Therapeutic Vaccine, in Patients With Myasthenia Gravis

Clinical Trial Summary

Study CV-0002 is the first clinical trial administering CV-MG01 in humans. This clinical trial is a safety and proof-of-concept study (proof of mechanism of action) intended to assess the safety, tolerability and immunogenic response following 3 subcutaneous injections of CV-MG01 as a potential therapeutic vaccine / active immunotherapy in myasthenia gravis (MG) patients.

Clinical Trial Description

Part A of the trial has been designed as a human safety pharmacology and therapeutic exploratory, parallel group, randomised, placebo-controlled, single centre, Investigator and subject-blind study using adaptive dose and sample size approaches.

At the end of part A of the present study, all patients, including those receiving placebo, will be monitored in an open label, long-term safety follow-up part B of the study to assess the treatment effects over time. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02609022
Study type Interventional
Source CuraVac
Contact
Status Completed
Phase Phase 1/Phase 2
Start date March 2016
Completion date September 30, 2018
View Details
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