Single and Multiple Dose Evaluation of QBKPN SSI In Healthy Volunteers

August 23, 2017 updated by: Qu Biologics Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse events [Safety and Tolerability]
Time Frame: 2 weeks
Incidence, severity, and dose-relationship of adverse events, vital signs, and clinical laboratory parameters
2 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in cellular biomarkers over time
Time Frame: 2 weeks
Absolute (#/mL) and Differentials (%)
2 weeks
Immunological biomarkers analysis
Time Frame: 2 weeks
2 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
MAD Cohorts only: Changes in cell surface markers on neutrophils and monocytes over time
Time Frame: 2 weeks
2 weeks
MAD cohorts only: Gene Expression Analysis
Time Frame: 2 weeks
2 weeks
Phenotype and Genotype Correlation [Exploratory gene association analysis]
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Qu Biologics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 13, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • QBKPN-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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