Rabies
Conditions
Keywords
Rabies, Rabies virus, Rhabdoviridae, Rabies immune globulin, Rabies antibodies, Passive rabies immunization
Brief 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.
Interventions
BIOLOGICALRIG-C
Sponsors
Grifols Therapeutics LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rabies Virus Antibody Titer | 10 days post-RIG-C dosing |
Secondary
| Measure | Time frame |
|---|---|
| Number of subjects who discontinue due to adverse events | 21 days |
Countries
United States
Outcome results
None listed