Safety, Tolerability and PK of Repeat Administration of Intravenous ETI-204 in Adult Volunteers

Completed · Phase 1 · Has a placebo group

Conditions studied: Inhalational Anthrax

In brief

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

Key facts

Study ID

NCT01932242

Run by

Elusys Therapeutics

People needed

70

Starts

2013-07-23

Expected to finish

2014-04-19

Last updated by the study team

2019-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Females or males ≥ 18 years of age
• All females, regardless of childbearing potential, must have a negative serum beta human chorionic gonadotropin (β-hCG) pregnancy test at Screening and Day -1
• 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
• 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
• Females who have undergone surgical sterilization, including hysterectomy, bilateral oophorectomy, bilateral salpingectomy, tubal ligation, or tubal essure
• 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
• Provide written informed consent
• Willing to comply with study restrictions

You may not qualify if…

• Pregnant or lactating woman
• Clinically significant comorbidity that would interfere with completion of the study procedures or objectives or compromise the subject's safety
• Seated systolic blood pressure (BP) ≥ 150 mmHg or ≤ 90 mmHg or diastolic BP ≥ 95 mmHg
• Use of H1 receptor antagonists (i.e. antihistamines) within 5 days prior to Day 1
• Evidence of drug or alcohol abuse as determined by the Investigator within 6 months of Day 1
• Positive test result for drugs of abuse (with the exception of medically prescribed drugs) at Screening or on Day -1
• 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
• Treatment with an investigational agent within 30 days or five half-lives of the investigational agent at Day 1 (whichever is longer)
• Congenital or acquired immunodeficiency syndrome
• Prior solid organ or bone marrow transplant
• Positive test for Hepatitis B (surface antigen), Hepatitis C, or human immunodeficiency virus (HIV) at Screening
• History of prior treatment for anthrax exposure or prior anthrax infection
• 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)
• 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
• 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
• Donation or loss of > 500 mL of blood within 30 days or plasma within 7 days of Day 1
• Prior stroke, epilepsy, relapsing or degenerative central nervous system disease, or relapsing or degenerative ocular disease
• Myocardial infarction or acute coronary syndrome in the past 5 years, active angina pectoris, or heart failure (New York Heart Association scale > 1)
• History of chronic liver disease
• Calculated creatinine clearance (CrCl) of < 30 mL/min using the Cockcroft-Gault equation (see Section 5.1)
• 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.
• History of allergic or hypersensitivity reactions to other therapeutic antibodies or immunoglobulins
• 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
• 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

Where it is running

• Quintiles — Overland Park, Kansas, United States
• DaVita — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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