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Anthrax clinical trials

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NCT ID: NCT01932437 Completed - Clinical trials for Inhalational Anthrax

Intramuscular Dose-Escalation Study With ETI-204 in Adult Volunteers

Start date: July 26, 2013
Phase: Phase 1
Study type: Interventional

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

NCT ID: NCT01932242 Completed - Clinical trials for Inhalational Anthrax

Safety, Tolerability and PK of Repeat Administration of Intravenous ETI-204 in Adult Volunteers

Start date: July 23, 2013
Phase: Phase 1
Study type: Interventional

To evaluate the safety, tolerability, pharmacokinetics and immunogenicity of repeat administration (two doses) of intravenous (IV) ETI-204.

NCT ID: NCT01929226 Completed - Clinical trials for Inhalational Anthrax

Safety, Tolerability, and PK of a Single Intravenous Dose of ETI-204 in Adult Volunteers

Start date: July 9, 2013
Phase: Phase 1
Study type: Interventional

To evaluate the safety and tolerability and pharmacokinetics (PK) of a single intravenous (IV) dose of ETI-204 in adult volunteers.

NCT ID: NCT01867957 Completed - Anthrax Clinical Trials

Efficacy and Safety of Anthrax Vaccine, GC1109

Start date: February 2009
Phase: Phase 1
Study type: Interventional

1. BACKGROUND The newly developed anthrax vaccine GC1109 has been proven safe and effective in preclinical studies. 2. OBJECTIVE - To evaluate the immunogenicity and safety of the anthrax vaccine GC1109 in healthy male volunteers. 3. STUDY DESIGN - single-blinded - randomized - placebo controlled - phase 1 study

NCT ID: NCT01794182 Completed - Ischemic Stroke Clinical Trials

Glyburide Advantage in Malignant Edema and Stroke - Remedy Pharmaceuticals

GAMES-RP
Start date: June 13, 2013
Phase: Phase 2
Study type: Interventional

This is a randomized, multi-center, prospective, double blind study. The primary objective is to assess the efficacy and safety of glyburide (RP-1127) compared to placebo in participants with a severe anterior circulation ischemic stroke who are likely to develop malignant edema.This objective will be addressed by comparing the proportion of glyburide treated particpants and placebo treated participants with a Day 90 modified Rankin Scale (mRS) ≤ 4 without decompressive craniectomy (DC). The secondary objective is to assess the efficacy of RP-1127 compared to placebo in participants with a severe anterior circulation ischemic stroke who were likely to develop malignant edema.

NCT ID: NCT01770743 Completed - Anthrax Clinical Trials

A Phase 2 Safety and Immunogenicity Study for an Anthrax Vaccine Using 3 Schedules and Two Dose Levels

Start date: January 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and immunogenicity of an anthrax vaccine. The vaccine schedule and dose will also be assessed.

NCT ID: NCT01753115 Completed - Anthrax Clinical Trials

Ciprofloxacin BioThrax Co-Administration Study

Start date: December 2012
Phase: Phase 2
Study type: Interventional

The purpose of this clinical trial is to determine whether there is any effect on the antibiotic, ciprofloxacin when taken before and after administration of a 3-dose series of BioThrax® (Anthrax Vaccine Adsorbed or AVA). This study will be conducted in the United States (US) in 154 healthy male and female volunteer subjects ages 18 to 45. The duration of study participation for each subject will be approximately 76 days (approximately 2.5 months)

NCT ID: NCT01653392 Completed - Clinical trials for Pregnancy Complications

BioThrax® (Anthrax) Vaccine in Pregnancy Registry

Start date: July 2012
Phase:
Study type: Observational

The purpose of this study is to determine if inadvertent receipt of the BioThrax vaccine during pregnancy is independently associated with adverse maternal, pregnancy, or infant health outcomes.

NCT ID: NCT01641991 Completed - Clinical trials for Bacillus Anthracis (Anthrax)

Assessment of the Immunogenicity and Safety of a Dose-Sparing BioThrax® AVA Schedule

Start date: July 2012
Phase: Phase 4
Study type: Interventional

A Phase IV, randomized, multicenter trial to assess the immunogenicity and safety of BioThrax® in varying dose regimens with the primary objective of obtaining information on possible dose-sparing strategies in the event of a major biothreat.

NCT ID: NCT01624532 Completed - Anthrax Clinical Trials

A Study to Assess Dose-Response, Efficacy (Immunogenicity) and the Safety of GC1109

GC1109
Start date: July 14, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to Assess Dose-Response, Efficacy (Immunogenicity) and the Safety of GC1109 Administered in Multi Intramuscular Doses to Healthy Subjects.