Study of Single Doses of IV Aerucin in Healthy Adults

• Sponsor: Aridis Pharmaceuticals, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02486770
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arms: 3
• Duration (Months): 5
• Patients Per Site Per Month: 3.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Biological: Aerucin 2.0mg/kg; Biological: Aerucin 8.0mg/kg; Biological: Aerucin 20.0 mg/kg	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: 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
• Study Start Date: Apr 1, 2015
• Actual Primary Completion Date: Sep 1, 2015
• Actual Study Completion Date: Sep 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Adverse Events [28 and 84 days following dosing]

   Number and % of subjects experiencing adverse events following dosing

2. Serious Adverse Events [24 and 84 days following dosing]

   Number and % of subjects experiencing Serious Adverse Events following dosing

3. Solicited Adverse Events [7 days following dosing]

   Number and % of subjects experiencing Solicited Adverse Events following dosing

Secondary Outcome Measures

1. CMax -Observed maximum plasma concentration [84 days following dosing]

   Pharmacokinetics Characteristics

2. TMax-Time to reach maximum plasma concentration [84 days following dosing]

   Pharmacokinetics Characteristics

3. AUC0-last Area under the the concentration time curve [84 days following dosing]

   Pharmacokinetics Characteristics

4. AUC0-∞ Area under the concentration time curve from zero to infinite time [84 days following dosing]

   Pharmacokinetics Characteristics

5. Terminal phase elimination rate [84 days following dosing]

   Pharmacokinetics Characteristics

6. Terminal elimination half-life [84 days following dosing]

   Pharmacokinetics Characteristics

Other Outcome Measures

1. Anti-Aerucin Antibodies [84 days following dosing]

   Exploratory analysis-evaluation of development of antibodies may be performed

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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 -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SNBL-CPC	Baltimore	Maryland	United States	21201

Sponsors and Collaborators

• Aridis Pharmaceuticals, Inc.

Investigators

• Principal Investigator: Mohammed Al-Ibrahim, MD, SNBL

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aridis Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT02486770
• Other Study ID Numbers: ARC-11-01
• First Posted: Jul 1, 2015
• Last Update Posted: Dec 30, 2015
• Last Verified: Dec 1, 2015

Study Results

No Results Posted as of Dec 30, 2015