Single and Multiple Dose Evaluation of QBKPN SSI In Healthy Volunteers
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
1 other identifier
interventional
N/A
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2016
Typical duration for phase_1 healthy
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedFirst Posted
Study publicly available on registry
September 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedAugust 24, 2017
August 1, 2017
5 months
August 19, 2016
August 23, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Changes in cellular biomarkers over time
2 weeks
Immunological biomarkers analysis
2 weeks
Other Outcomes (3)
MAD Cohorts only: Changes in cell surface markers on neutrophils and monocytes over time
2 weeks
MAD cohorts only: Gene Expression Analysis
2 weeks
Phenotype and Genotype Correlation [Exploratory gene association analysis]
2 weeks
Study Arms (10)
SAD Cohort 1
EXPERIMENTALSingle dose of 0.05 mL QBKPN or Placebo
SAD Cohort 2
EXPERIMENTALSingle dose of 0.10 mL QBKPN or Placebo
SAD Cohort 3
EXPERIMENTALSingle dose of 0.20 mL QBKPN or Placebo
SAD Cohort 4
EXPERIMENTALSingle dose of 0.40 mL QBKPN or Placebo
SAD Cohort 5
EXPERIMENTALSingle dose of 0.80 mL QBKPN or Placebo
SAD Cohort 6
EXPERIMENTALSingle dose of 1.2 mL QBKPN or Placebo
MAD Cohort 1
EXPERIMENTAL5 doses of QBKPN or Placebo administered every other day (using one of the dose from the SAD Cohort)
MAD Cohort 2
EXPERIMENTAL5 doses of QBKPN or Placebo administered every other day (using one of the dose from the SAD Cohort)
MAD Cohort 3
EXPERIMENTAL5 doses of QBKPN or Placebo administered every day (using one of the dose from the SAD Cohort)
MAD Cohort 4
EXPERIMENTAL5 doses of QBKPN or Placebo administered every day (using one of the dose from the SAD Cohort)
Interventions
QBKPN Site Specific Immunomodulators
Placebo
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2016
First Posted
September 13, 2016
Study Start
September 1, 2016
Primary Completion
February 1, 2017
Study Completion
February 1, 2017
Last Updated
August 24, 2017
Record last verified: 2017-08