Single and Multiple Dose Evaluation of QBKPN SSI In Healthy Volunteers

Study Overview
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Brief Summary
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The purpose of this dose-escalation study is to assess the safety and pharmacodynamics of single and multiple doses of QBKPN SSI, administered subcutaneously to healthy adult volunteers

Official Title
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A Placebo-Controlled, Blinded, Dose-Escalation, Study to Assess the Safety and Pharmacodynamics of Single and Multiple Doses of QBKPN (Inactivated Klebsiella Pneumoniae) Site Specific Immunomodulator (SSI), Administered Subcutaneously to Healthy Male and Female Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Biological: QBKPN
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy, non-smoking (at least for 6 months prior to first study drug administration) males or females, 18 to 65 years of age, inclusive at the time of informed consent. Body mass index (BMI) that is within 18.5 - 30.0 kg/m2, inclusive. Healthy, according to the medical history, ECG, vital signs, laboratory results and physical examination Systolic blood pressure between 95-140 mmHg, inclusive, and diastolic blood pressure between 55-90 mmHg, inclusive, and heart rate between 50-100 bpm, inclusive, unless deemed otherwise by the PI/Sub-Investigator. QTc interval ≤ 450 milliseconds for males and females, unless deemed otherwise Not Clinically Significant by the Principal Investigator/Sub-Investigator. Availability to volunteer for the entire study duration and willing to adhere to all protocol requirements. Agree not to have a tattoo or body piercing until the end of the study. Agree to practice effective methods of contraception Exclusion Criteria: Known history or presence of any clinically significant hepatic, renal/genitourinary, gastrointestinal, cardiovascular, cerebrovascular, pulmonary, endocrine, immunological, musculoskeletal, neurological, psychiatric, dermatological or hematological disease or condition unless determined as not clinically significant by the PI/Sub-Investigator. A known history or positive test result for human immunodeficiency virus (HIV), chronic Hepatitis B surface antigen, or Hepatitis C. A positive test result for drugs of abuse (marijuana, amphetamines, barbiturates, cocaine, opiates, phencyclidine and benzodiazepines), alcohol test and cotinine. Positive pregnancy test for female subjects. Known history or presence of (1) Alcohol abuse or dependence within one year prior to first study drug administration; (2) Drug abuse or dependence; (3) Known or suspected hypersensitivity to any component of the product (4) Food allergies and/or presence of any dietary restrictions; or (5) Severe allergic reactions (e.g. anaphylactic reactions, angioedema). Recent history (within 8 weeks prior to screening) of travel to or emigration from any country with high incidence for tuberculosis. A positive tuberculin skin (PPD) test result

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SAD Cohort 1<br>Single dose of 0.05 mL QBKPN or Placebo | Biological: QBKPN<br>* QBKPN Site Specific Immunomodulators<br>Other: Placebo<br>* Placebo<br>|
| Experimental: SAD Cohort 2<br>Single dose of 0.10 mL QBKPN or Placebo | Biological: QBKPN<br>* QBKPN Site Specific Immunomodulators<br>Other: Placebo<br>* Placebo<br>|
| Experimental: SAD Cohort 3<br>Single dose of 0.20 mL QBKPN or Placebo | Biological: QBKPN<br>* QBKPN Site Specific Immunomodulators<br>Other: Placebo<br>* Placebo<br>|
| Experimental: SAD Cohort 4<br>Single dose of 0.40 mL QBKPN or Placebo | Biological: QBKPN<br>* QBKPN Site Specific Immunomodulators<br>Other: Placebo<br>* Placebo<br>|
| Experimental: SAD Cohort 5<br>Single dose of 0.80 mL QBKPN or Placebo | Biological: QBKPN<br>* QBKPN Site Specific Immunomodulators<br>Other: Placebo<br>* Placebo<br>|
| Experimental: SAD Cohort 6<br>Single dose of 1.2 mL QBKPN or Placebo | Biological: QBKPN<br>* QBKPN Site Specific Immunomodulators<br>Other: Placebo<br>* Placebo<br>|
| Experimental: MAD Cohort 1<br>5 doses of QBKPN or Placebo administered every other day (using one of the dose from the SAD Cohort) | Biological: QBKPN<br>* QBKPN Site Specific Immunomodulators<br>Other: Placebo<br>* Placebo<br>|
| Experimental: MAD Cohort 2<br>5 doses of QBKPN or Placebo administered every other day (using one of the dose from the SAD Cohort) | Biological: QBKPN<br>* QBKPN Site Specific Immunomodulators<br>Other: Placebo<br>* Placebo<br>|
| Experimental: MAD Cohort 3<br>5 doses of QBKPN or Placebo administered every day (using one of the dose from the SAD Cohort) | Biological: QBKPN<br>* QBKPN Site Specific Immunomodulators<br>Other: Placebo<br>* Placebo<br>|
| Experimental: MAD Cohort 4<br>5 doses of QBKPN or Placebo administered every day (using one of the dose from the SAD Cohort) | Biological: QBKPN<br>* QBKPN Site Specific Immunomodulators<br>Other: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse events [Safety and Tolerability] | Incidence, severity, and dose-relationship of adverse events, vital signs, and clinical laboratory parameters | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in cellular biomarkers over time | Absolute (#/mL) and Differentials (%) | 2 weeks | 
| Immunological biomarkers analysis |  | 2 weeks |