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

Rabies Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02139657
• Other study ID #: GTI1301
• Status: Completed
• Phase: Phase 1
• First received: April 28, 2014
• Last updated: July 22, 2014
• Start date: March 2014
• Est. completion date: May 2014

Study information

• Verified date: July 2014
• Source: Grifols Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rabies

Intervention

Biological:
• RIG-C

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Grifols Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rabies Virus Antibody Titer		10 days post-RIG-C dosing	No
Secondary	Number of subjects who discontinue due to adverse events		21 days	Yes