NCT05421325: RESILIENCE

Assessment of QBKPN Site-Specific Immunomodulator (SSI) Efficacy in Improving Innate Immune Function and Reducing All-Cause Respiratory Tract Infection Morbidity in Adults 65 Years of Age or Older Residing in the Community, in Independent-Living, Assisted-Living and Long-term Care Facilities

Recruiting now Phase 2 Last updated 21 January 2025

What this trial tests

Phase 2 trial testing QBKPN SSI in Immune Deficiency in 72 participants. Currently enrolling.

Timeline

11 April 2023

Primary endpoint
1 September 2025

1 February 2026

Quick facts

Lead sponsor	Qu Biologics Inc.
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	72
Start date	11 April 2023
Primary completion	1 September 2025
Estimated completion	1 February 2026
Sites	1 location across Canada

Drugs / interventions tested

• QBKPN SSI — full drug profile →
• Normal Saline Placebo

Conditions studied

• Immune Deficiency — all drugs for Immune Deficiency →

Sponsor

Qu Biologics Inc. — full company profile →

Who can join

65 and older, any sex, with Immune Deficiency. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Evaluate innate immune training in participants treated with QBKPN SSI compared to placebo.
  Time frame: Baseline to End of Treatment (EOT) (Week 4)
  Innate immune training will be measured by change in stimulated IL-β using RBM Myriad's TLR4 ligand (LPS) TruCulture Tube assay.
• Incidence of treatment-emergent adverse events (safety & tolerability) in participants treated with QBKPN SSI compared to placebo.
  Time frame: Baseline to EOT (Week 4) and Week 8
  Treatment-emergent adverse events assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
• Change in clinical laboratory parameters (safety & tolerability) measured by blood hematology analysis in participants treated with QBKPN SSI compared to placebo.
  Time frame: Baseline to EOT (Week 4) and Week 8
  Hematology analysis includes: Hematocrit (Hct), Hemoglobin (Hgb), Mean Corpuscular Hemoglobin (MCH), Mean Corpuscular Hemoglobin Concentration (MCHC), Mean Corpuscular Volume (MCV), platelet count, Red Blood Cell (RBC) count, White Blood Cell (WBC) count with differential.
• Change in clinical laboratory parameters (safety & tolerability) measured by blood chemistry analysis in participants treated with QBKPN SSI compared to placebo.
  Time frame: Baseline to EOT (Week 4) and Week 8
  Clinical chemistry analysis includes: Alanine Aminotransferase (ALT), Albumin (ALB), Alkaline Phosphatase (ALK-P), Aspartate Aminotransferase (AST), bilirubin, Gamma-Glutamyl Transferase (GGT), creatinine, estimated Glomerular Filtration Rate (eGFR), C-Reactive Protein (CRP), electrolytes.
• Change in clinical laboratory parameters (safety & tolerability) measured by urinalysis in participants treated with QBKPN SSI compared to placebo.
  Time frame: Baseline to EOT (Week 4) and Week 8
  Urinalysis includes: blood, glucose, ketones, leukocyte esterase, nitrite, pH, protein and specific gravity.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pattern recognition receptors: function, regulation and therapeutic potential.
   Chen R, Zou J, Chen J, Zhong X, et al · · 2025 · cited 53× · PMID 40640149 · DOI 10.1038/s41392-025-02264-1
2. Targeting T-cell Aging to Remodel the Aging Immune System and Revitalize Geriatric Immunotherapy.
   Chen M, Su Z, Xue J. · · 2025 · cited 6× · PMID 40153576 · DOI 10.14336/ad.2025.0061
3. The inner fire: the shifting paradigm of complement system in aging.
   Triggianese P, Della-Morte D. · · 2026 · PMID 42058191 · DOI 10.3389/fimmu.2026.1795833