Healthy
Conditions
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
Interventions
BIOLOGICALQBKPN
QBKPN Site Specific Immunomodulators
OTHERPlacebo
Placebo
Sponsors
Qu Biologics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse events [Safety and Tolerability] | 2 weeks | Incidence, severity, and dose-relationship of adverse events, vital signs, and clinical laboratory parameters |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in cellular biomarkers over time | 2 weeks | Absolute (#/mL) and Differentials (%) |
| Immunological biomarkers analysis | 2 weeks | — |
Other
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed