An Open-label, Single-Arm Study to Evaluate the Safety and Rabies Virus Antibody Titers of Intramuscularly Administered Rabies Immune Globulin (Human)

Phase 1

Completed

• Conditions: Rabies
• Interventions: Biological: RIG-C

• Registration Number: NCT02139657
• Lead Sponsor: Grifols Therapeutics LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-04-28
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Study First Submitted QC: 2014-05-13
• Study First Posted: 2014-05-15
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-22
• Last Update Posted: 2014-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RIG-C	RIG-C	Single 20 IU/kg dose of RIG-C by intramuscular injection

Primary Outcome Measures

Name	Time	Method
Rabies Virus Antibody Titer	10 days post-RIG-C dosing

Secondary Outcome Measures

Name	Time	Method
Number of subjects who discontinue due to adverse events	21 days