Clinical trial NCT02897999: Single and Multiple Dose Evaluation of QBKPN SSI In Healthy Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Qu Biologics Inc.
Sponsor class: INDUSTRY
First posted: 2016-09-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse events [Safety and Tolerability]
timeFrame: 2 weeks
Secondary outcomes:
measure: Changes in cellular biomarkers over time
timeFrame: 2 weeks
measure: Immunological biomarkers analysis
timeFrame: 2 weeks
Other outcomes:
measure: MAD Cohorts only: Changes in cell surface markers on neutrophils and monocytes over time
timeFrame: 2 weeks
measure: MAD cohorts only: Gene Expression Analysis
timeFrame: 2 weeks
measure: Phenotype and Genotype Correlation [Exploratory gene association analysis]
timeFrame: 2 weeks
Locations:
Study officials:
References: