Safety, Tolerability, and PK of Single IM Doses of ETI-204 in Adult Volunteers
This study has been completed.
Information provided by (Responsible Party):
First received: August 2, 2013
Last updated: September 30, 2014
Last verified: April 2014
This study is to evaluate the safety and local tolerability of single intramuscular (IM) doses of ETI-204; to evaluate the pharmacokinetics (PK) of a single IM dose of ETI-204; and to evaluate the immunogenicity of a single IM dose of ETI-204.
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
||A Randomized, Double-Blind, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single Intramuscular Doses of ETI-204 in Adult Volunteers
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, injection site assessments, skin assessments for presence/absence of rash, and AEs.
Secondary Outcome Measures:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||July 2014 (Final data collection date for primary outcome measure)
Placebo Comparator: Placebo
Intramuscular (IM), single dose
Other Name: Placebo comparator
Intramuscular (IM), single dose
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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/cervical cap 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 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 to refrain from sperm donation from Screening during the study and for 30 days after the final study visit;
- Provide written informed consent;
- Willing to comply with study restrictions.
- Body weight >100 kg;
- Body mass index ≥32 kg/m2;
- Pregnant or lactating female;
- 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 within 6 months of Day 1 as determined by the Investigator;
- 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, subject to 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 5 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 (e.g., ETI-204, raxibacumab, or anthrax immune globulin);
- Military personnel deployed in 1990 or after, unless the subject can provide documentation demonstrating he or she has 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 of <30 mL/min using the Cockcroft-Gault equation;
- 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 tests may be repeated to confirm;
- History of allergic or hypersensitivity reaction or hives 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.
- Platelet count <140 K/µL;
- Prothrombin time/international normalized ratio or activated partial thromboplastin time >1.2 X the upper limit of normal at Screening or Day -1;
- Poor muscle mass as determined by the Investigator;
- Family or personal history of a bleeding disorder;
- History of unexplained bleeding;
- Use of any anticoagulant or anti-platelet drug for 3 months prior to Screening. At the discretion of the Investigator, daily aspirin may be taken for general health reasons.
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: NCT01932437
|Covance Clinical Research Unit Inc.
|Dallas, Texas, United States, 75247 |
No publications provided
ClinicalTrials.gov processed this record on March 01, 2015
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 2, 2013
||September 30, 2014
||United States: Food and Drug Administration