Study of Single Doses of IV Aerucin in Healthy Adults

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: Completed
• Conditions: Healthy
• Intervention / Treatment: Biological: Aerucin 2.0mg/kg; Biological: Aerucin 8.0mg/kg; Biological: Aerucin 20.0 mg/kg

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: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Aridis Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Mohammed Al-Ibrahim, MD, SNBL

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: April 8, 2015
• First Submitted That Met QC Criteria: June 30, 2015
• First Posted (Estimate): July 1, 2015

Study Record Updates

• Last Update Posted (Estimate): December 30, 2015
• Last Update Submitted That Met QC Criteria: December 28, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: ARC-11-01