An Open-label, Single-Arm Study to Evaluate the Safety and Rabies Virus Antibody Titers of Intram… (NCT02139657) | Clinical Trial Compass
CompletedPhase 1
An Open-label, Single-Arm Study to Evaluate the Safety and Rabies Virus Antibody Titers of Intramuscularly Administered Rabies Immune Globulin (Human)
United States12 participantsStarted 2014-03
Plain-language summary
This is a single-arm, open-label study of Rabies Immune Globulin (Human), Caprylate/Chromatography Purified (RIG-C), in approximately 12 healthy subjects. The purpose of this study is to characterize the rabies virus-specific antibody titer after a single intramuscular injection of 20 IU/kg RIG-C and to evaluate the safety and tolerability of RIG-C.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* In good health in the judgment of the Investigator as determined by medical history, physical examination, and screening laboratory assessments.
* Female of childbearing potential must have a negative result on the screening serum pregnancy test and must agree to practice contraception by a method of proven reliability (includes abstinence) for the duration of the study.
Exclusion Criteria:
* Pregnant or lactating females.
* Clinical evidence of any significant acute or chronic disease that may interfere with successful completion of the trial.
* Clinically significant history of the following: cardiovascular disease, hyperlipidemia, serious respiratory disease including bronchitis or asthma, endocrine disorder, liver disease, glaucoma, gastrointestinal disease, disorder of the reticuloendothelial system, or neurologic illness.
* History of angioedema or nephrotic syndrome.
* Non-controlled arterial hypertension.
* Anemia at screening.
* Significant proteinuria (\> 1 + on urine dipstick) and/or has a history of acute renal failure and/or severe renal impairment or a blood urea nitrogen or creatinine more than 2.5 times the upper limit of normal at screening and/or currently receiving dialysis.
* Elevated liver enzymes (aspartate transaminase, alanine aminotransferase) and Gamma-glutamyl Transferase) equal to or greater than 1.5 times the upper limit at screening.
* Previously received the rabies vaccine and/or rabies immune globulin.
* Received infusi…