A Study to Evaluate the Safety, Immunogenicity, and Pharmacokinetics of GR2102 in Healthy Adult

Launched by GENRIX (SHANGHAI) BIOPHARMACEUTICAL CO., LTD. · Mar 10, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new injection called GR2102, aimed at preventing Respiratory Syncytial Virus (RSV) infections, which can cause serious respiratory issues, especially in young children and older adults. The trial is in its first phase, where the main focus is to see how safe GR2102 is, how well it works in terms of creating an immune response, and how the body processes the injection. Participants will be placed in different groups and will randomly receive either the GR2102 injection or a placebo, which is a harmless substance that looks like the injection but has no active ingredients.

To participate in this study, individuals must be healthy adults between the ages of 18 and 65, and they need to sign a consent form to show they understand the trial. However, people who currently have symptoms of a respiratory infection, have received an RSV vaccine or treatment before, or have a history of certain cancers cannot join the trial. If you decide to participate, you can expect close monitoring for safety and effectiveness during the trial. This is an important step in developing potential new options for preventing RSV infections.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Healthy adult subjects
• • 2. Signed informed consent
• Exclusion Criteria:
• • 1. Signs and symptoms of upper respiratory tract infection prior to randomization
• • 2. Prior use of RSV vaccine or RSV antibody-based medications
• • 3. history of malignant tumor