an open-label, single-arm study to evaluate the safety and rabies virus antibody titers of intramuscularly administered rabies immune globulin (human)

Conditions: Rabies

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.


Eligibility criteria:
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 infusion of a blood/plasma product or fraction within the past 12 months, including any type of immune globulin. * known adverse reaction to administration of any immune globulin or other blood/plasma products. * experienced anaphylactic shock with the administration of blood/plasma products. * known medical history of selective immunoglobulin a (iga) deficiency. * received any corticosteroids, immunosuppressants, or immunomodulators within 6 weeks prior to screening. * expects to receive oral or topical non-steroidal anti-inflammatory drugs (nsaids), acetaminophen, antihypertensives, and/or antihistamines 24 hours before or after investigational product administration during the baseline/treatment, study day 0 visit. * currently receiving any anti-viral treatment. * screening laboratory results indicative of an acute or chronic infection with hepatitis a virus (hav), hepatitis b virus (hbv), hepatitis c virus (hcv), human immunodeficiency virus (hiv), or parvovirus b19 (b19v). * participated in another clinical trial within 30 days prior to screening (imaging studies without investigative treatments are permitted) or has received any investigational products within the previous 3 months. * not willing to postpone receiving any live virus vaccines until 3 months after receiving investigational product. * history of a psychiatric illness requiring hospitalization. * known substance or prescription drug abuse in the past 12 months. * any active medical illness that the investigator may consider a potential confounding condition that would interfere with the study visits and/or procedures.

Keywords: rabies rabies virus rhabdoviridae rabies immune globulin rabies antibodies passive rabies immunization