A Study to Assess the Safety, Tolerability and PK of a Single IV Dose of ETI-204 in Adult Volunteers (AH104)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Elusys Therapeutics
ClinicalTrials.gov Identifier:
NCT01929226
First received: August 2, 2013
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

To evaluate the safety and tolerability and pharmacokinetics (PK) of a single intravenous (IV) dose of ETI-204 in adult volunteers.


Condition Intervention Phase
Inhalational Anthrax
Biological: ETI-204
Biological: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Safety, Tolerability, and PK of a Single Intravenous Dose of ETI-204 in Adult Volunteers

Resource links provided by NLM:


Further study details as provided by Elusys Therapeutics:

Primary Outcome Measures:
  • Number of Adverse Events [ Time Frame: 71 Days ] [ Designated as safety issue: Yes ]
    Safety assessments will be assessed by collecting and monitoring vital signs, clinical laboratory tests, ECGs, physical examinations, skin assessments, infusion site assessments, and AEs.


Secondary Outcome Measures:
  • Pharmacokinetics (PK) analysis [ Time Frame: 71 Days ] [ Designated as safety issue: No ]
    All PK parameters will be determined for a single intravenous administration of ETI-204.

  • Anti-ETI-204 Antibody [ Time Frame: 71 days ] [ Designated as safety issue: No ]
    Immunogenicity measured by the percentage of subjects in each study arm with anti-ETI-204 antibody values greater than or equal to cutpoint at Day 1, 8, 43 and 71.


Enrollment: 280
Study Start Date: July 2013
Study Completion Date: April 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ETI-204
Intravenously (IV), single dose
Biological: ETI-204
Monoclonal Antibody
Placebo Comparator: Placebo
Intravenously (IV), single dose
Biological: Placebo
Placebo comparator
Other Name: Placebo comparator

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Females or males ≥ 18 years of age
  2. All females, regardless of childbearing potential, must have a negative serum beta human chorionic gonadotropin (β-hCG) pregnancy test at Screening and Day -1
  3. Females of childbearing potential (i.e., not postmenopausal or surgically sterile) must agree to practice abstinence or to use a medically accepted method of contraception from the time of Screening through 30 days after final study visit. Acceptable methods of contraception include diaphragm with spermicide; sponge with spermicide; condom with spermicide; or intrauterine device with condom or spermicide. The following contraceptive methods are acceptable only when used with a condom and spermicide: birth control pills, birth control patches, vaginal ring, hormone under the skin, or hormone injections
  4. Postmenopausal females, defined as females who have had amenorrhea for at least 12 months either naturally or following cessation of all exogenous hormonal treatments and have a follicle stimulating hormone (FSH) level of > 40 mIU/mL at Screening
  5. Females who have undergone surgical sterilization, including hysterectomy, bilateral oophorectomy, bilateral salpingectomy, tubal ligation, or tubal essure
  6. Males must agree to practice abstinence or use a condom with spermicide and refrain from sperm donation during the study and for 30 days after the final study visit
  7. Provide written informed consent
  8. Willing to comply with study restrictions

Exclusion Criteria:

  1. Pregnant or lactating woman
  2. Clinically significant comorbidity that would interfere with completion of the study procedures or objectives, or compromise the subject's safety
  3. Seated systolic blood pressure (BP) ≥ 150 mmHg or ≤ 90 mmHg or diastolic BP ≥ 95 mmHg
  4. Use of H1 receptor antagonists (i.e. antihistamines) within 5 days prior to Day 1
  5. Evidence of drug or alcohol abuse as determined by the Investigator within 6 months of Day 1
  6. Positive test result for drugs of abuse (with the exception of medically prescribed drugs) at Screening or on Day -1
  7. Positive test for alcohol at Screening; exclusion is subject to the Investigator's discretion; subjects who test positive for alcohol at Day -1 are excluded from the study
  8. Treatment with an investigational agent within 30 days of Day 1 or within five half-lives of the investigational agent at Day 1 (whichever is longer)
  9. Congenital or acquired immunodeficiency syndrome
  10. Prior solid organ or bone marrow transplant
  11. Positive test for Hepatitis B (surface antigen), Hepatitis C, or human immunodeficiency virus (HIV) at Screening
  12. History of prior treatment for anthrax exposure or prior anthrax infection
  13. Prior immunization with any approved or investigational anthrax vaccine or prior treatment with an investigational anthrax treatment (i.e., ETI-204, raxibacumab, or anthrax immune globulin)
  14. Military personnel deployed in 1990 or after, unless the subject can provide documentation demonstrating they have not previously received any approved or investigational anthrax vaccine
  15. Use of systemic steroids, immunosuppressive agents, anticoagulants, or anti-arrhythmics within 1 year prior to Day 1. A single short course (i.e., less than 14 days) of systemic steroid therapy is allowed provided it concluded more than 6 months prior to Day 1
  16. Donation or loss of > 500 mL of blood within 30 days or plasma within 7 days of Day 1
  17. Prior stroke, epilepsy, relapsing or degenerative central nervous system disease, or relapsing or degenerative ocular disease
  18. Myocardial infarction or acute coronary syndrome in the past 5 years, active angina pectoris, or heart failure (New York Heart Association scale > 1)
  19. History of chronic liver disease
  20. Calculated creatinine clearance (CrCl) of < 30 mL/min using the Cockcroft-Gault equation
  21. Any clinically significant abnormality, in the Investigator's opinion, on electrocardiogram (ECG) or clinical laboratory tests (hematology, clinical chemistry, or urinalysis) at Screening; Out of range results may be repeated to confirm.
  22. History of allergic or hypersensitivity reactions to other therapeutic antibodies or immunoglobulins
  23. History of any malignant neoplasm within the last 5 years, with the exception of adequately treated localized or in situ non-melanoma carcinoma of the skin (i.e., basal cell carcinoma) or the cervix
  24. Subjects who, in the opinion of the Investigator, are not suitable candidates for enrollment or who may not comply with the requirements of the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01929226

Locations
United States, Texas
Covance Clinical Research Inc.
Dallas, Texas, United States, 75247
Sponsors and Collaborators
Elusys Therapeutics
Investigators
Principal Investigator: Alex King, MD Covance Clinical Research Unit Inc.
Principal Investigator: Lori Sieboldt, MD Covance Clinical Research - Evansville, IN
Principal Investigator: Debra Mandarino, MD Covance Research, Madison, WI
Principal Investigator: H. Frank Farmer, PhD, MD Covance Research - Daytona Beach, Fl
  More Information

No publications provided

Responsible Party: Elusys Therapeutics
ClinicalTrials.gov Identifier: NCT01929226     History of Changes
Other Study ID Numbers: AH104
Study First Received: August 2, 2013
Last Updated: April 10, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anthrax
Respiratory Tract Infections
Bacillaceae Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Infection
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 30, 2014