Safety, Tolerability and PK of Intravenous (IV) ETI-204 Alone and in Presence of Ciprofloxacin in Adult Volunteers

Completed · Phase 1

Conditions studied: Inhalational Anthrax

In brief

Evaluate the safety, tolerability and pharmacokinetics (PK) of intravenous (IV) ETI-204 alone and in the presence of IV and oral ciprofloxacin

Key facts

Study ID

NCT01952444

Run by

Elusys Therapeutics

People needed

40

Starts

2013-10-29

Expected to finish

2014-04-09

Last updated by the study team

2019-04-16

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Females or males between 18 and 60 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 ≥ 3 months prior to Screening. Tubal essure requires radiological confirmation of occlusion of the fallopian tubes. Subjects who cannot provide documentation may participate if they agree to follow the methods of contraception specified in Inclusion Criterion #3
• 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. Note this does not apply to males who have undergone a vasectomy and can provide documentation of confirmatory sperm count 3 months post procedure.
• Provide written informed consent
• Willing to comply with study restrictions (see Section 4.5.3 for a complete list of 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
• Supine 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 or Day -1
• 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 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
• Therapeutic 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 CNS 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 > I)
• 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
• Exclusion Criteria Specific to the Use of Ciprofloxacin

Where it is running

• Quintiles — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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