Single and Multiple Dose Evaluation of QBKPN SSI In Healthy Volunteers

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02897999
• Other study ID #: QBKPN-03
• Status: Withdrawn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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Healthy

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