Clinical trial NCT02486770: Study of Single Doses of IV Aerucin in Healthy Adults
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Aridis Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2015-07-01
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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 -

Primary outcomes:
measure: Adverse Events
timeFrame: 28 and 84 days following dosing
measure: Serious Adverse Events
timeFrame: 24 and 84 days following dosing
measure: Solicited Adverse Events
timeFrame: 7 days following dosing
Secondary outcomes:
measure: CMax -Observed maximum plasma concentration
timeFrame: 84 days following dosing
measure: TMax-Time to reach maximum plasma concentration
timeFrame: 84 days following dosing
measure: AUC0-last Area under the the concentration time curve
timeFrame: 84 days following dosing
measure: AUC0-∞ Area under the concentration time curve from zero to infinite time
timeFrame: 84 days following dosing
measure: Terminal phase elimination rate
timeFrame: 84 days following dosing
measure: Terminal elimination half-life
timeFrame: 84 days following dosing
Other outcomes:
measure: Anti-Aerucin Antibodies
timeFrame: 84 days following dosing
Locations:
city: Baltimore
country: United States
facility: SNBL-CPC
state: Maryland
Study officials:
affiliation: SNBL
name: Mohammed Al-Ibrahim, MD
role: PRINCIPAL_INVESTIGATOR
References: