Actively Recruiting

Phase 2
Age: 65Years +
All Genders
NCT05421325

Efficacy of QBKPN Site-Specific Immunomodulator in Improving Innate Immune Function & Reducing Respiratory Tract Infection in Older Adults

Led by Qu Biologics Inc. · Updated on 2025-01-22

72

Participants Needed

1

Research Sites

146 weeks

Total Duration

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Sponsors

Q

Qu Biologics Inc.

Lead Sponsor

T

The National Research Council of Canada Industrial Research Assistance Program

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study is designed to test whether QBKPN SSI can improve immune function in older adults, including how well it can protect against respiratory and other infections, whether it improves the body's response to COVID-19 vaccines, what effect it has on maintaining or improving quality of life, activity level and health status and whether it has an effect on glycemic control. QBKPN is a new medication in a class known as Site-Specific Immunomodulators (SSI). SSIs are designed to train and/or improve innate immune function to reduce the risk of infections, improve immune response to cancer, and slow the progression of chronic inflammatory diseases. It is believed that QBKPN SSI can work with the immune system to help protect against respiratory and other infections.

CONDITIONS

Official Title

Efficacy of QBKPN Site-Specific Immunomodulator in Improving Innate Immune Function & Reducing Respiratory Tract Infection in Older Adults

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be a resident of the community or a long-term care, independent-living, or assisted living facility participating in the study
  • Be aged 65 years or older
  • Be able to provide written, informed consent themselves
  • Male subjects engaged in vaginal intercourse with women of childbearing potential must be surgically sterile or agree to practice effective barrier contraception during the entire study treatment period and one month after last dose or agree to abstain from vaginal intercourse with women of childbearing potential during this period
Not Eligible

You will not qualify if you...

  • Life expectancy of less than 3 months due to terminal illness
  • Taking biologic immunosuppressive agents or other systemic immunosuppressants except NSAIDs, colchicine, aspirin, or low-dose oral glucocorticoids
  • Currently being treated or treated within 30 days for infection with systemic antibiotics or antivirals
  • Known allergy or hypersensitivity to killed whole-cell bacterial vaccines
  • Any condition that would preclude participation due to safety or monitoring concerns
  • Treatment with experimental or investigational therapies within 3 months prior to screening or planned during study participation
  • On current treatment for active malignancies or planned cancer surgery during the study period, except hormonal therapy for breast or prostate cancer or surgery for localized skin cancers

AI-Screening

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Trial Site Locations

Total: 1 location

1

Qu Biologics Trial Site

Burnaby, British Columbia, Canada, V5G 4X4

Actively Recruiting

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Research Team

O

Oksana Korolova, Director, Clinical Operations

CONTACT

H

Hal Gunn, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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