Healthy Clinical Trial
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
Verified date | August 2017 |
Source | Qu Biologics Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | February 2017 |
Est. primary completion date | February 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Qu Biologics Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | MAD Cohorts only: Changes in cell surface markers on neutrophils and monocytes over time | 2 weeks | ||
Other | MAD cohorts only: Gene Expression Analysis | 2 weeks | ||
Other | Phenotype and Genotype Correlation [Exploratory gene association analysis] | 2 weeks | ||
Primary | 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 | Changes in cellular biomarkers over time | Absolute (#/mL) and Differentials (%) | 2 weeks | |
Secondary | Immunological biomarkers analysis | 2 weeks |
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