An Open-label, Single-Arm Study to Evaluate the Safety and Rabies Virus Antibody Titers of Intramuscularly Administered Rabies Immune Globulin (Human)
Primary Purpose
Rabies
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
RIG-C
Sponsored by
About this trial
This is an interventional treatment trial for Rabies focused on measuring Rabies, Rabies virus, Rhabdoviridae, Rabies immune globulin, Rabies antibodies, Passive rabies immunization
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
RIG-C
Arm Description
Single 20 IU/kg dose of RIG-C by intramuscular injection
Outcomes
Primary Outcome Measures
Rabies Virus Antibody Titer
Secondary Outcome Measures
Number of subjects who discontinue due to adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02139657
Brief Title
An Open-label, Single-Arm Study to Evaluate the Safety and Rabies Virus Antibody Titers of Intramuscularly Administered Rabies Immune Globulin (Human)
Official Title
An Open-label, Single-arm Study to Evaluate the Safety and Antibody Titers Specific to the Rabies Virus in Healthy Subjects After Receiving a Single Dose of Intramuscularly Administered Rabies Immune Globulin (Human)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Grifols Therapeutics LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rabies
Keywords
Rabies, Rabies virus, Rhabdoviridae, Rabies immune globulin, Rabies antibodies, Passive rabies immunization
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RIG-C
Arm Type
Experimental
Arm Description
Single 20 IU/kg dose of RIG-C by intramuscular injection
Intervention Type
Biological
Intervention Name(s)
RIG-C
Other Intervention Name(s)
Rabies Immune Globulin (Human), Caprylate/Chromatography Purified
Primary Outcome Measure Information:
Title
Rabies Virus Antibody Titer
Time Frame
10 days post-RIG-C dosing
Secondary Outcome Measure Information:
Title
Number of subjects who discontinue due to adverse events
Time Frame
21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29983597
Citation
Hanna K, Cruz MC, Mondou E, Corsi E, Vandeberg P. Safety and neutralizing rabies antibody in healthy subjects given a single dose of rabies immune globulin caprylate/chromatography purified. Clin Pharmacol. 2018 Jun 26;10:79-88. doi: 10.2147/CPAA.S166454. eCollection 2018.
Results Reference
derived
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An Open-label, Single-Arm Study to Evaluate the Safety and Rabies Virus Antibody Titers of Intramuscularly Administered Rabies Immune Globulin (Human)
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