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

NCT02139657 | Completed Phase 1

• 1 other identifier: GTI1301
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Rabies

Keywords

Rabies; Rabies virus; Rhabdoviridae; Rabies immune globulin; Rabies antibodies; Passive rabies immunization

Outcome Measures

Primary Outcomes (1)

• Rabies Virus Antibody Titer

  10 days post-RIG-C dosing

Secondary Outcomes (1)

• Number of subjects who discontinue due to adverse events

  21 days

Study Arms (1)

RIG-C

EXPERIMENTAL

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

Biological: RIG-C

Interventions

RIG-C BIOLOGICAL

Also known as: Rabies Immune Globulin (Human), Caprylate/Chromatography Purified

RIG-C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Grifols Therapeutics LLC: lead

Study Sites (1)

Unknown Facility

Tempe, Arizona, 85283, United States

Location

Related Publications (1)

• 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.

  PMID: 29983597 DERIVED

MeSH Terms

Conditions

Rabies

Interventions

Caprylates

Condition Hierarchy (Ancestors)

Rhabdoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2014
• First Posted: May 15, 2014
• Study Start: March 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: July 24, 2014

Record last verified: 2014-07

Locations

US (1)