MedDataX Logo

Single and Multiple Dose Evaluation of QBKPN SSI In Healthy Volunteers

NCT ID: NCT02897999

Last Updated: 2017-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Pharmacokinetics of KBPA-101 in Hospital Acquired Pneumonia Caused by O11 Pseudomonas Aeruginosa

NCT00851435

Pneumonia Ventilator Associated Pneumonia
COMPLETED PHASE1/PHASE2

Phase 1 Randomized Double-blind Placebo Controlled Study to Evaluate Safety and PK of MEDI3902 in Healthy Adults

NCT02255760

MEDI3902 for Prevention of P. Aeruginosa Pneumonia
COMPLETED PHASE1

Single-dose PK Study of Benapenem In Healthy Subjects

NCT03588156

Healthy Subject
COMPLETED PHASE1

Safety and Immunogenicity Study of Prophylactic Streptococcus Pneumoniae Vaccine

NCT01995617

Streptococcus Pneumoniae
COMPLETED PHASE1

Selective Digestive Decontamination in Carriers of Carbapenem-resistant Klebsiella Pneumoniae

NCT00753558

Carriage of Carbapemen-resistant Klebsialle Pneumoniae
COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SAD Cohort 1

Single dose of 0.05 mL QBKPN or Placebo

Group Type EXPERIMENTAL

QBKPN

Intervention Type BIOLOGICAL

QBKPN Site Specific Immunomodulators

Placebo

Intervention Type OTHER

Placebo

SAD Cohort 2

Single dose of 0.10 mL QBKPN or Placebo

Group Type EXPERIMENTAL

QBKPN

Intervention Type BIOLOGICAL

QBKPN Site Specific Immunomodulators

Placebo

Intervention Type OTHER

Placebo

SAD Cohort 3

Single dose of 0.20 mL QBKPN or Placebo

Group Type EXPERIMENTAL

QBKPN

Intervention Type BIOLOGICAL

QBKPN Site Specific Immunomodulators

Placebo

Intervention Type OTHER

Placebo

SAD Cohort 4

Single dose of 0.40 mL QBKPN or Placebo

Group Type EXPERIMENTAL

QBKPN

Intervention Type BIOLOGICAL

QBKPN Site Specific Immunomodulators

Placebo

Intervention Type OTHER

Placebo

SAD Cohort 5

Single dose of 0.80 mL QBKPN or Placebo

Group Type EXPERIMENTAL

QBKPN

Intervention Type BIOLOGICAL

QBKPN Site Specific Immunomodulators

Placebo

Intervention Type OTHER

Placebo

SAD Cohort 6

Single dose of 1.2 mL QBKPN or Placebo

Group Type EXPERIMENTAL

QBKPN

Intervention Type BIOLOGICAL

QBKPN Site Specific Immunomodulators

Placebo

Intervention Type OTHER

Placebo

MAD Cohort 1

5 doses of QBKPN or Placebo administered every other day (using one of the dose from the SAD Cohort)

Group Type EXPERIMENTAL

QBKPN

Intervention Type BIOLOGICAL

QBKPN Site Specific Immunomodulators

Placebo

Intervention Type OTHER

Placebo

MAD Cohort 2

5 doses of QBKPN or Placebo administered every other day (using one of the dose from the SAD Cohort)

Group Type EXPERIMENTAL

QBKPN

Intervention Type BIOLOGICAL

QBKPN Site Specific Immunomodulators

Placebo

Intervention Type OTHER

Placebo

MAD Cohort 3

5 doses of QBKPN or Placebo administered every day (using one of the dose from the SAD Cohort)

Group Type EXPERIMENTAL

QBKPN

Intervention Type BIOLOGICAL

QBKPN Site Specific Immunomodulators

Placebo

Intervention Type OTHER

Placebo

MAD Cohort 4

5 doses of QBKPN or Placebo administered every day (using one of the dose from the SAD Cohort)

Group Type EXPERIMENTAL

QBKPN

Intervention Type BIOLOGICAL

QBKPN Site Specific Immunomodulators

Placebo

Intervention Type OTHER

Placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

QBKPN

QBKPN Site Specific Immunomodulators

Intervention Type BIOLOGICAL

Placebo

Placebo

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Qu Biologics Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

QBKPN-03

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Pharmacokinetic and Pharmacogenetic Study in Patients Receiving Sulfamethoxazole-trimethoprim Therapy
NCT02045160 UNKNOWN
Evaluation of the Safety, Tolerability and Pharmacokinetics of Intravenous ETX2514 Administered in Healthy Subjects
NCT02971423 COMPLETED PHASE1
A Randomized, Single Blind, Placebo Controlled Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Oral Doses and Repeat Escalating Oral Doses of GSK2251052 in Healthy Adult Subjects
NCT01262885 COMPLETED PHASE1
Study to Evaluate Safety, Tolerability, and Pharmacokinetics of XNW4107 Alone or in Combination With Imipenem/Cilastatin
NCT04482569 COMPLETED PHASE1
Open-Label Study to Evaluate Safety of A Single Dose of SYM-1219
NCT02452866 COMPLETED PHASE3
A Controlled Trial Comparing the Efficacy of Aerosolized Pentamidine and Parenteral / Oral Trimethoprim - Sulfamethoxazole in the Treatment of Pneumocystis Carinii Pneumonia in AIDS
NCT00002056 COMPLETED NA
Inhaled Amikacin Solution BAY41-6551 as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia
NCT01799993 COMPLETED PHASE3
A Randomized, Double-Blind, Placebo Controlled Study of l-Leucovorin in Combination With Trimethoprim / Sulfamethoxazole in the Therapy of Pneumocystis Carinii Pneumonia in Patients With the Acquired Immunodeficiency Syndrome
NCT00002002 COMPLETED NA
Study Evaluating Tigecycline in Selected Serious Infections Due to Resistant Gram-Negative Organisms
NCT00079989 COMPLETED PHASE3
Multiple Oritavancin Doses on Safety, Tolerability, and Pharmacokinetics in Healthy Subjects
NCT02470702 COMPLETED PHASE1
A Phase III Study to Evaluate the Safety, Efficacy and Pharmacokinetics/Pharmacodynamics of BAYQ3939 in Patients With Bacterial Pneumonia
NCT01561794 COMPLETED PHASE3
A Study of Trimetrexate Plus Leucovorin in Children With Pneumocystis Carinii Pneumonia
NCT00002317 COMPLETED NA
Phase 1, Single-Dose and Multiple-Dose Continuous Intravenous Infusions of TNP-2092 for Injection in Healthy Chinese Participants
NCT06394518 COMPLETED PHASE1
Phase 1 Study of Oral QPX2015 in Healthy Adult Subjects
NCT03939429 COMPLETED PHASE1
Low Dose Trimethoprim-Sulfamethoxazole for the Treatment of Pneumocystis Jirovecii Pneumonia
NCT04851015 NOT_YET_RECRUITING PHASE3
Study to Determine and Compare Plasma and Intrapulmonary Concentrations of ETX2514 and Sulbactam in Healthy Subjects
NCT03303924 COMPLETED PHASE1
A Study Investigating the Safety, Recovery, and Pharmacodynamics of Multiple Oral Administrations of SNIPR001 in Healthy Subjects
NCT05277350 COMPLETED PHASE1
A Double-Blind Study To Evaluate the Long-Term Safety and Effectiveness of 60 mg Versus 120 mg of Aerosol Pentamidine in the Prophylaxis of Pneumocystis Carinii Pneumonia in AIDS Patients
NCT00002054 COMPLETED NA
Study Evaluating Piperacillin-Tazobactam on Certain Bacteria in Hematology and Oncology Units
NCT00167999 COMPLETED
A Safety and Tolerability Study of Doripenem in Patients With Abdominal Infections or Pneumonia
NCT00515034 COMPLETED PHASE2
Safety, Tolerability, Pharmacokinetics of Intravenous RPX7009 in Healthy Adult Subjects
NCT01751269 COMPLETED PHASE1
A Study of Neutrexin Plus Leucovorin in the Treatment of Pneumocystis Carinii Pneumonia (PCP)
NCT00002434 COMPLETED NA
Corticosteroids for PJP in Non-HIV Immunocompromised Adults
NCT07152613 NOT_YET_RECRUITING PHASE3
Safety, Tolerability and PK of Intravenous (IV) ETI-204 Alone and in Presence of Ciprofloxacin in Adult Volunteers
NCT01952444 COMPLETED PHASE1
Comparison of Trimetrexate Plus Leucovorin Calcium Rescue Versus Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS
NCT00001013 COMPLETED PHASE3