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Single and Multiple Dose Evaluation of QBKPN SSI In Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02897999
Recruitment Status : Withdrawn
First Posted : September 13, 2016
Last Update Posted : August 24, 2017
Sponsor:
Information provided by (Responsible Party):
Qu Biologics Inc.

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

Condition or disease Intervention/treatment Phase
Healthy Biological: QBKPN Other: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Study Start Date : September 2016
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SAD Cohort 1
Single dose of 0.05 mL QBKPN or Placebo
Biological: QBKPN
QBKPN Site Specific Immunomodulators

Other: Placebo
Placebo

Experimental: SAD Cohort 2
Single dose of 0.10 mL QBKPN or Placebo
Biological: QBKPN
QBKPN Site Specific Immunomodulators

Other: Placebo
Placebo

Experimental: SAD Cohort 3
Single dose of 0.20 mL QBKPN or Placebo
Biological: QBKPN
QBKPN Site Specific Immunomodulators

Other: Placebo
Placebo

Experimental: SAD Cohort 4
Single dose of 0.40 mL QBKPN or Placebo
Biological: QBKPN
QBKPN Site Specific Immunomodulators

Other: Placebo
Placebo

Experimental: SAD Cohort 5
Single dose of 0.80 mL QBKPN or Placebo
Biological: QBKPN
QBKPN Site Specific Immunomodulators

Other: Placebo
Placebo

Experimental: SAD Cohort 6
Single dose of 1.2 mL QBKPN or Placebo
Biological: QBKPN
QBKPN Site Specific Immunomodulators

Other: Placebo
Placebo

Experimental: MAD Cohort 1
5 doses of QBKPN or Placebo administered every other day (using one of the dose from the SAD Cohort)
Biological: QBKPN
QBKPN Site Specific Immunomodulators

Other: Placebo
Placebo

Experimental: MAD Cohort 2
5 doses of QBKPN or Placebo administered every other day (using one of the dose from the SAD Cohort)
Biological: QBKPN
QBKPN Site Specific Immunomodulators

Other: Placebo
Placebo

Experimental: MAD Cohort 3
5 doses of QBKPN or Placebo administered every day (using one of the dose from the SAD Cohort)
Biological: QBKPN
QBKPN Site Specific Immunomodulators

Other: Placebo
Placebo

Experimental: MAD Cohort 4
5 doses of QBKPN or Placebo administered every day (using one of the dose from the SAD Cohort)
Biological: QBKPN
QBKPN Site Specific Immunomodulators

Other: Placebo
Placebo




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Changes in cellular biomarkers over time [ Time Frame: 2 weeks ]
    Absolute (#/mL) and Differentials (%)

  2. Immunological biomarkers analysis [ Time Frame: 2 weeks ]

Other Outcome Measures:
  1. MAD Cohorts only: Changes in cell surface markers on neutrophils and monocytes over time [ Time Frame: 2 weeks ]
  2. MAD cohorts only: Gene Expression Analysis [ Time Frame: 2 weeks ]
  3. Phenotype and Genotype Correlation [Exploratory gene association analysis] [ Time Frame: 2 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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Responsible Party: Qu Biologics Inc.
ClinicalTrials.gov Identifier: NCT02897999     History of Changes
Other Study ID Numbers: QBKPN-03
First Posted: September 13, 2016    Key Record Dates
Last Update Posted: August 24, 2017
Last Verified: August 2017
Additional relevant MeSH terms:
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Immunologic Factors
Physiological Effects of Drugs