Study of Single Doses of IV Aerucin in Healthy Adults

December 28, 2015 updated by: Aridis Pharmaceuticals, Inc.

A Phase 1 Single-center (U.S.), Open Label, Dose-escalation Study of the Safety and Pharmacokinetics of Single Doses of Intravenous AerucinTM in Healthy Adult Subjects

This study will evaluate the safety profile and pharmacokinetic behavior of a single administration of Aerucin in healthy adults at three different dosages.

Study Overview

Status

Status

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

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.

Detailed Description

This Phase I trial will be conducted as an open label trial in 15 healthy adults. All subjects will receive a specific intravenous dose of Aerucin. There are three study groups, each with a specific dose of Aerucin. Study Group 1 will receive 2.0 mg/ kg of Aerucin . Study Group 2 will receive 8.0 mg/kg of Aerucin . Study Group 3 will receive 20 mg/kg of Aerucin . The dose levels of Aerucin are selected for this study based on animal studies showing protection in an animal model and absence of adverse effects in toxicological studies. Groups will be enrolled sequentially.

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

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • SNBL-CPC

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 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Has completed the written informed consent process
  2. Is male or female
  3. Is age ≥18 years and ≤50 years
  4. Agrees to stay in contact with the study site for the duration of the study, provide updated contact information as necessary, and has no current plans to move from the study area for the duration of the study
  5. Agrees to avoid elective surgery for the duration of the study
  6. For female subjects: agrees to have avoided pregnancy from 14 days prior to Study Day 0 through the duration of the study. Women physically capable of pregnancy (not sterilized and still menstruating or within 1 year of the last menses if menopausal) in sexual relationships with men must use an acceptable method of avoiding pregnancy during this period. Acceptable methods of avoiding pregnancy include: a sterile sexual partner; sexual abstinence (not engaging in any sexual intercourse); hormonal contraceptives (oral, injection, transdermal patch, or implant); vaginal ring; intrauterine device (IUD); or condom.
  7. Has general good health, confirmed by medical history and physical examination
  8. Has body mass index (BMI) between 18 and 30 (weight/height) -

Exclusion Criteria:

  1. Oral temperature ≥37.5°C
  2. Abnormal CBC laboratory values (per local laboratory parameters) from blood collected at screening (>5% above ULN or >5% below LLN)
  3. Abnormally elevated laboratory values (per local laboratory parameters) from blood collected at screening for ALT, AST, total bilirubin, alkaline phosphatase (ALP), blood urea nitrogen (BUN), creatinine (Cr), (>10% above ULN)
  4. Abnormal urinalysis that, in the opinion of the investigator, is clinically significant
  5. Positive screening urine test for illicit drugs (opiates, cocaine, amphetamines)
  6. Has received an immunoglobulin product in the 120 days prior to Study Day 0
  7. History or evidence of autoimmune disease
  8. History or evidence of any past, present, or future possible immunodeficiency state, including laboratory evidence of HIV 1 infection.
  9. History or evidence of chronic hepatitis
  10. History of evidence of Pseudomonas infection
  11. Received a systemic antibiotic with 14 days prior to Study Day 0
  12. Participation in any other investigational study during the study period
  13. Received immunoglobulin or blood products within 90 days prior to Study Day 0
  14. Received any investigational drug therapy or investigational drug within 60 days prior to Study Day 0
  15. Received immunosuppressive medications other than inhaled or topical immunosuppressants within 45 days prior to Study Day 0
  16. Inability to discontinue daily medications during the study other than: oral contraceptives, vitamins, nonprescription nutritional supplements, aspirin, antihistamines inhaled corticosteroids, inhaled beta agonists, inhaled anticholinergics
  17. All female subjects: currently pregnant or lactating/nursing; positive screening urine pregnancy test; or positive urine pregnancy test on the day of any study dosing
  18. History or evidence of allergic disease or reaction that, in the opinion of the investigator, may compromise the safety of the subject
  19. History or evidence of any other acute or chronic disease that, in the opinion of the investigator, may interfere with the evaluation of the safety or immunogenicity of the drug or compromise the safety of the subject
  20. Medical, psychiatric, occupational, or substance abuse problems that, in the opinion of the investigator, will make it unlikely that the subject will comply with the protocol
  21. Any other reason at discretion of the investigator -

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: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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: Group 1
Aerucin 2.0mg/kg
Biological: Aerucin 2.0mg/kg
IV Aerucin 2.0 mg/kg over 1 hour
Experimental: Group 2
Aerucin 8.0mg/kg
Biological: Aerucin 8.0mg/kg
IV Aerucin 8.0 mg/kg over 1 hour
Experimental: Group 3
Aerucin 20.0mg/kg
Biological: Aerucin 20.0 mg/kg
IV Aerucin 20 mg/kg over 1 hour

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
Adverse Events
Time Frame: 28 and 84 days following dosing
Number and % of subjects experiencing adverse events following dosing
28 and 84 days following dosing
Serious Adverse Events
Time Frame: 24 and 84 days following dosing
Number and % of subjects experiencing Serious Adverse Events following dosing
24 and 84 days following dosing
Solicited Adverse Events
Time Frame: 7 days following dosing
Number and % of subjects experiencing Solicited Adverse Events following dosing
7 days following dosing

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
CMax -Observed maximum plasma concentration
Time Frame: 84 days following dosing
Pharmacokinetics Characteristics
84 days following dosing
TMax-Time to reach maximum plasma concentration
Time Frame: 84 days following dosing
Pharmacokinetics Characteristics
84 days following dosing
AUC0-last Area under the the concentration time curve
Time Frame: 84 days following dosing
Pharmacokinetics Characteristics
84 days following dosing
AUC0-∞ Area under the concentration time curve from zero to infinite time
Time Frame: 84 days following dosing
Pharmacokinetics Characteristics
84 days following dosing
Terminal phase elimination rate
Time Frame: 84 days following dosing
Pharmacokinetics Characteristics
84 days following dosing
Terminal elimination half-life
Time Frame: 84 days following dosing
Pharmacokinetics Characteristics
84 days following dosing

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
Measure Description
Time Frame
Anti-Aerucin Antibodies
Time Frame: 84 days following dosing
Exploratory analysis-evaluation of development of antibodies may be performed
84 days following dosing

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.
Aridis Pharmaceuticals, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mohammed Al-Ibrahim, MD, SNBL

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.
April 1, 2015

Primary Completion (Actual)

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.
September 1, 2015

Study Completion (Actual)

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.
September 1, 2015

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).
April 8, 2015

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.
June 30, 2015

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.
July 1, 2015

Study Record Updates

Last Update Posted (Estimate)

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.
December 30, 2015

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.
December 28, 2015

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.
December 1, 2015

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.
  • ARC-11-01

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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