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

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

Study Overview

• Status: Withdrawn
• Conditions: Healthy
• Intervention / Treatment: Other: Placebo; Biological: QBKPN

• Study Type: Interventional
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SAD Cohort 1; Single dose of 0.05 mL QBKPN or Placebo	Other: Placebo; Placebo; Biological: QBKPN; QBKPN Site Specific Immunomodulators
Experimental: SAD Cohort 2; Single dose of 0.10 mL QBKPN or Placebo	Other: Placebo; Placebo; Biological: QBKPN; QBKPN Site Specific Immunomodulators
Experimental: SAD Cohort 3; Single dose of 0.20 mL QBKPN or Placebo	Other: Placebo; Placebo; Biological: QBKPN; QBKPN Site Specific Immunomodulators
Experimental: SAD Cohort 4; Single dose of 0.40 mL QBKPN or Placebo	Other: Placebo; Placebo; Biological: QBKPN; QBKPN Site Specific Immunomodulators
Experimental: SAD Cohort 5; Single dose of 0.80 mL QBKPN or Placebo	Other: Placebo; Placebo; Biological: QBKPN; QBKPN Site Specific Immunomodulators
Experimental: SAD Cohort 6; Single dose of 1.2 mL QBKPN or Placebo	Other: Placebo; Placebo; Biological: QBKPN; QBKPN Site Specific Immunomodulators
Experimental: MAD Cohort 1; 5 doses of QBKPN or Placebo administered every other day (using one of the dose from the SAD Cohort)	Other: Placebo; Placebo; Biological: QBKPN; QBKPN Site Specific Immunomodulators
Experimental: MAD Cohort 2; 5 doses of QBKPN or Placebo administered every other day (using one of the dose from the SAD Cohort)	Other: Placebo; Placebo; Biological: QBKPN; QBKPN Site Specific Immunomodulators
Experimental: MAD Cohort 3; 5 doses of QBKPN or Placebo administered every day (using one of the dose from the SAD Cohort)	Other: Placebo; Placebo; Biological: QBKPN; QBKPN Site Specific Immunomodulators
Experimental: MAD Cohort 4; 5 doses of QBKPN or Placebo administered every day (using one of the dose from the SAD Cohort)	Other: Placebo; Placebo; Biological: QBKPN; QBKPN Site Specific Immunomodulators

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in cellular biomarkers over time	Absolute (#/mL) and Differentials (%)	2 weeks
Immunological biomarkers analysis		2 weeks

Other Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Qu Biologics Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): February 1, 2017
• Study Completion (Anticipated): February 1, 2017

Study Registration Dates

• First Submitted: August 19, 2016
• First Submitted That Met QC Criteria: September 7, 2016
• First Posted (Estimate): September 13, 2016

Study Record Updates

• Last Update Posted (Actual): August 24, 2017
• Last Update Submitted That Met QC Criteria: August 23, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: QBKPN-03