Recruiting
Phase 2

QBKPN

Sponsor:

Qu Biologics Inc.

Code:

NCT05421325

Conditions

Immune Deficiency

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

QBKPN SSI

Normal Saline Placebo

Study Details

Brief summary:

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

Immune Deficiency

Study ID

NCT05421325

Start date

Apr 11, 2023

Status verified date

Jan, 2025

Completion date

Feb, 2026

Anticipated

Primary completion date

Sep, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Be a resident of the community or a long-term care, independent-living or assisted living facility participating in the study
2. Be aged 65 years or older
3. Be able to provide written, informed consent themselves
4. 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 (4 weeks) and one month after the last dose of study drug or agree to completely abstain from vaginal intercourse with women of childbearing potential during this period.

Exclusion Criteria:

1. Life expectancy of less than 3 months due to terminal illness as determined by the Study Investigator
2. Taking biologic immunosuppressive agents (e.g., Anti-Tumour Necrosis Factor Alpha (anti-TNFa) antibodies, rituximab, ibrutinib, imatinib) calcineurin inhibitors, myelosuppressants (e.g., methotrexate, mycophenolate), or other systemic immunosuppressants. Note: NSAIDs, colchicine, aspirin and oral glucocorticoids at a dose equivalent to less than or equal to 5mg prednisone per day are allowed
3. Currently being treated or less than 30 days from being treated for confirmed or probable infection with systemic (i.e., not topical) antibiotics or antivirals
4. Have a known allergy or hypersensitivity to killed whole-cell bacterial vaccines
5. Any condition that, in the opinion of the Investigator, would preclude the person from participation in the study due to safety or monitoring concerns
6. Any treatment with experimental or investigational therapies within 3 months prior to Screening and/or any planned treatment with experimental or investigational therapies during the entire course of study participation
7. On current treatment for active malignancies (e.g., chemotherapy, radiation) or planned cancer surgery during the study period. Note: People on exclusively hormonal therapy for breast or prostate cancer are allowed. People with prior or planned surgery for localized squamous cell or basal cell carcinoma of the skin are allowed

Study Design

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: QBKPN SSI

QBKPN SSI (0.1 mL) by subcutaneous injection 3 times per week (Monday, Wednesday \& Friday) for 4 weeks.

placebo comparator: Placebo

Placebo (Normal Saline) (0.1 mL) by subcutaneous injection 3 times per week (Monday, Wednesday \& Friday) for 4 weeks.

Interventions

QBKPN SSI

Site-Specific Immunomodulator

Normal Saline Placebo

Normal Saline

Primary outcome measure

  • Evaluate innate immune training in participants treated with QBKPN SSI compared to placebo. [ Time Frame: Baseline to End of Treatment (EOT) (Week 4) ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Oksana Korolova, Director, Clinical Operations

236-512-3119okorolova@qubiologics.com

Locations

Qu Biologics Trial Site

Recruiting

Burnaby, British Columbia, Canada, V5G 4X4

Contacts

Principal Investigator:

Theodore Steiner, MD FRCPC

More Information

Sponsor

Qu Biologics Inc.

Last update posted

Jan 22, 2025

Last verified

Jan, 2025

Keywords

  • Immunosenescence
  • immunodegeneration
  • immune dysfunction
  • older adult

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Qu Biologics Inc. on 2025-01-22.