Clinical trials: Inhalational Anthrax
Inhalational Anthrax
Safety, Tolerability and PK of Intravenous (IV) ETI-204 Alone and in Presence of Ciprofloxacin in Adult Volunteers
Evaluate the safety, tolerability and pharmacokinetics (PK) of intravenous (IV) ETI-204 alone and in the presence of IV and oral ciprofloxacin
- Trial name
- NCT01952444
- Testing
- ETI-204, Ciprofloxacin
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Elusys Therapeutics
Inhalational Anthrax
Intramuscular Dose-Escalation Study With ETI-204 in Adult Volunteers
This study is to evaluate the safety, local tolerability, pharmacokinetics (PK) and immunogenicity of escalating single intramuscular (IM) doses of ETI-204 in healthy volunteers
- Trial name
- NCT01932437
- Testing
- ETI-204
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Elusys Therapeutics
Infection, Bacterial, Anthrax
An Open Label Field Study of Anthim (Obiltoxaximab) in Subjects Exposed to B. Anthracis
This field study is a post-marketing requirement from the FDA to evaluate the clinical benefit (course of illness and survival), safety and pharmacokinetics of obiltoxaximab administered to patients as part of their medical care…
- Trial name
- NCT03088111
- Testing
- Collection of samples, Obiltoxaximab
- Volunteers
- 100 people
- Sponsor
- Elusys Therapeutics
Inhalational Anthrax
Safety, Tolerability, and PK of a Single Intravenous Dose of ETI-204 in Adult Volunteers
To evaluate the safety and tolerability and pharmacokinetics (PK) of a single intravenous (IV) dose of ETI-204 in adult volunteers.
- Trial name
- NCT01929226
- Testing
- ETI-204
- Where
- United States
- Volunteers
- 280 people, healthy volunteers welcome
- Sponsor
- Elusys Therapeutics
Inhalational Anthrax
A Field Study Evaluating Clinical Benefit and Safety of AIGIV (ANTHRASIL®) in Inhalational Anthrax Patients
This study will evaluate safety and clinical benefit of AIGIV used for treatment of patients with inhalational anthrax. This study will be implemented only in the event of a major anthrax exposure event.
- Trial name
- NCT03569553
- Testing
- AIGIV
- Volunteers
- 100 people
- Sponsor
- Emergent BioSolutions
Inhalational Anthrax
Safety, Tolerability and PK of Repeat Administration of Intravenous ETI-204 in Adult Volunteers
To evaluate the safety, tolerability, pharmacokinetics and immunogenicity of repeat administration (two doses) of intravenous (IV) ETI-204.
- Trial name
- NCT01932242
- Testing
- ETI-204
- Where
- 2 sites in United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Elusys Therapeutics
Infections, Bacterial
Clinical Benefit and Safety of Raxibacumab in Patients With Symptomatic Inhalational Anthrax in a Mass Exposure Scenario
This field study is designed such that it may be implemented for any individual with symptomatic inhalational anthrax who has been administered raxibacumab for treatment of anthrax following a mass exposure scenario.
- Trial name
- NCT02177721
- Testing
- Sample Collection
- Volunteers
- 100 people
- Sponsor
- Emergent BioSolutions
Anthrax
Evaluation of Clinical Benefit and Safety Following CYFENDUS Administration for Post-Exposure Prophylaxis of Anthrax Disease.
The goal of this observational study is to evaluate the safety and clinical benefit of two doses of CYFENDUS vaccine when used with the concurrent recommended antibacterial regimen for post-exposure prophylaxis to prevent…
- Trial name
- NCT07268612
- Testing
- CYFENDUS
- Volunteers
- 250 people
- Sponsor
- Emergent BioSolutions
Therapeutic Treatment of Inhalation Anthrax
An Open-label, Nonrandomized Study to Evaluate the Safety and Immunogenicity of Raxibacumab With Reinjection
This is an open-label study to evaluate the immunogenicity and safety of raxibacumab in healthy adult male and female subjects. Subjects who have received raxibacumab >= 4 months ago will be enrolled and dosed as follows: A…
- Trial name
- NCT02016963
- Testing
- Raxibacumab
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Human Genome Sciences Inc.
Symptoms of Inhalational Anthrax
Safety and Pharmacokinetic Study of Anthrax Immune Globulin Derived From Human Serum
The purpose of the study is to assess the pharmacokinetics of three doses of NP-015 (210, 420 or 840 units TNA) in healthy volunteers. To evaluate the safety of NP-015 based on adverse events and laboratory assessments.
- Trial name
- NCT00448253
- Testing
- NP-015
- Where
- United States
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Bacillus Anthracis (Anthrax)
Monoclonal Antibody for Treatment of Inhalation Anthrax
The purpose of this study is to evaluate the safety and pharmacokinetics (how long a drug stays in the bloodstream and how high the levels of the drug are at different times) of ETI-204 following intravenous (IV-into a vein)…
- Trial name
- NCT00138411
- Testing
- Ciprofloxacin 500 mg, ETI-204 (Anthim)
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)