Study of Single Doses of IV Aerucin in Healthy Adults

NCT02486770 | Completed Phase 1

• 1 other identifier: ARC-11-01
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• CMax -Observed maximum plasma concentration

  84 days following dosing

• TMax-Time to reach maximum plasma concentration

  84 days following dosing

• AUC0-last Area under the the concentration time curve

  84 days following dosing

• AUC0-∞ Area under the concentration time curve from zero to infinite time

  84 days following dosing

• Terminal phase elimination rate

  84 days following dosing

Other Outcomes (1)

• Anti-Aerucin Antibodies

  84 days following dosing

Study Arms (3)

Group 1

EXPERIMENTAL

Aerucin 2.0mg/kg

Biological: Aerucin 2.0mg/kg

Group 2

EXPERIMENTAL

Aerucin 8.0mg/kg

Biological: Aerucin 8.0mg/kg

Group 3

EXPERIMENTAL

Aerucin 20.0mg/kg

Biological: Aerucin 20.0 mg/kg

Interventions

Aerucin 2.0mg/kg BIOLOGICAL

IV Aerucin 2.0 mg/kg over 1 hour

Group 1

Aerucin 8.0mg/kg BIOLOGICAL

IV Aerucin 8.0 mg/kg over 1 hour

Group 2

Aerucin 20.0 mg/kg BIOLOGICAL

IV Aerucin 20 mg/kg over 1 hour

Group 3

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Has completed the written informed consent process
• Is male or female
• Is age ≥18 years and ≤50 years
• 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
• Agrees to avoid elective surgery for the duration of the study
• 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.
• Has general good health, confirmed by medical history and physical examination
• Has body mass index (BMI) between 18 and 30 (weight/height) -

You may not qualify if:

• Oral temperature ≥37.5°C
• Abnormal CBC laboratory values (per local laboratory parameters) from blood collected at screening (\>5% above ULN or \>5% below LLN)
• 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)
• Abnormal urinalysis that, in the opinion of the investigator, is clinically significant
• Positive screening urine test for illicit drugs (opiates, cocaine, amphetamines)
• Has received an immunoglobulin product in the 120 days prior to Study Day 0
• History or evidence of autoimmune disease
• History or evidence of any past, present, or future possible immunodeficiency state, including laboratory evidence of HIV 1 infection.
• History or evidence of chronic hepatitis
• History of evidence of Pseudomonas infection
• Received a systemic antibiotic with 14 days prior to Study Day 0
• Participation in any other investigational study during the study period
• Received immunoglobulin or blood products within 90 days prior to Study Day 0
• Received any investigational drug therapy or investigational drug within 60 days prior to Study Day 0
• Received immunosuppressive medications other than inhaled or topical immunosuppressants within 45 days prior to Study Day 0

Sponsors & Collaborators

• Aridis Pharmaceuticals, Inc.: lead

Study Sites (1)

SNBL-CPC

Baltimore, Maryland, 21201, United States

Location

Study Officials

• Mohammed Al-Ibrahim, MD

  SNBL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2015
• First Posted: July 1, 2015
• Study Start: April 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: December 30, 2015

Record last verified: 2015-12

Locations

US (1)