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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02897999
Other study ID # QBKPN-03
Secondary ID
Status Withdrawn
Phase Phase 1
First received August 19, 2016
Last updated August 23, 2017
Start date September 2016
Est. completion date February 2017

Study information

Verified date August 2017
Source Qu Biologics Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Withdrawn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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
QBKPN
QBKPN Site Specific Immunomodulators
Other:
Placebo
Placebo

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Qu Biologics Inc.

Outcome

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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