Safety, Tolerability and PK of Repeat Administration of IV ETI-204

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Elusys Therapeutics
ClinicalTrials.gov Identifier:
NCT01932242
First received: August 2, 2013
Last updated: November 6, 2013
Last verified: November 2013
  Purpose

To evaluate the safety and tolerability of repeat administration (two doses) of intravenous (IV). To evaluate the pharmacokinetics and immunogenicity of ETI-204 after repeat IV administration.


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: A Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of Repeat Administration of Intravenous 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: 220 days ] [ Designated as safety issue: Yes ]
    Safety will be assessed by collecting and monitoring vital signs, laboratory tests, ECGs, physical examinations, skin assessments, infusion site assessments and AEs.


Secondary Outcome Measures:
  • Pharmacokinetics (PK) analysis [ Time Frame: 220 days ] [ Designated as safety issue: No ]
    All PK parameters will be descriptively analyzed by treatment/dosing group for the PK analysis population.

  • Anti-ETI-204 Antibody [ Time Frame: 220 days ] [ Designated as safety issue: No ]
    Anti-ETI-204 analyses at each time point will be listed by subject and summarized as appropriate.


Estimated Enrollment: 70
Study Start Date: July 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ETI-204
Intravenously (IV), repeat dose
Biological: ETI-204
Monoclonal Antibody
Placebo Comparator: Placebo
Intravenously (IV), repeat 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 the 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 at 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 or 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 approved or 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 (see Section 5.1)
  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 (e.g., 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

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  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01932242

Locations
United States, Kansas
Quintiles
Overland Park, Kansas, United States, 66211
United States, Minnesota
DaVita
Minneapolis, Minnesota, United States, 55404
Sponsors and Collaborators
Elusys Therapeutics
Investigators
Principal Investigator: David Mathews, MD Quintiles
  More Information

No publications provided

Responsible Party: Elusys Therapeutics
ClinicalTrials.gov Identifier: NCT01932242     History of Changes
Other Study ID Numbers: AH109
Study First Received: August 2, 2013
Last Updated: November 6, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anthrax
Bacillaceae Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on July 22, 2014