Clinical trials: Anthrax
Osmolality Disturbance, Lab Interference
Effect of Activated Charcoal on Serum Osmolality, Osmolal Gap, and Enzymatic Ethylene Glycol Assay
The goal of this observational study is to determine whether a clinically relevant dose of activated charcoal raises the serum osmolality and osmolal gap in a population of healthy volunteers.
- Trial name
- NCT07220031
- Testing
- Activated Charcoal
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- State University of New York - Upstate Medical University
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
HIV Infections
A Phase I Study of Safety and Immunogenicity of the WRAIR HIV-1 Vaccine
To evaluate the safety of LFn-p24 administered at three different doses with Alhydrogel given intramuscularly To evaluate immune responses to LFn-p24 with Alhydrogel at three different doses given intramuscularly
- Trial name
- NCT00412477
- Testing
- HIV LFn-p24
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
Healthy Volunteers
Foster With or Without Charcoal Block or Aerochamber Plus
The purpose of this study is to evaluate the systemic exposure of BDP, its metabolite beclomethasone 17-monopropionate (B17MP) and formoterol after inhalation of BDP/Formoterol 100/6 µg pMDI combination (CHF1535) using the…
- Trial name
- NCT01280175
- Testing
- charcoal block, Aerochamber Plus spacer, pMDI standard actuator
- Where
- Switzerland
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
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
Anthrax
Single Dose, Weight-Based, Dose-Escalation Study With Intravenous ETI-204 in Adult Volunteers
This study will determine the safety and PK of a single IV dose of ETI-204 in subjects 18 to 65 years of age. Three cohorts will be studied with subjects receiving ETI-204.
- Trial name
- NCT01453907
- Testing
- ETI-204, "Anthim"
- Where
- United States
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Elusys Therapeutics
Anthrax
Efficacy and Safety of Anthrax Vaccine, GC1109
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.
- Trial name
- NCT01867957
- Testing
- Low-dose GC1109, High-dose GC1109
- Where
- South Korea
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Seoul National University Hospital
Bacillus Anthracis (Anthrax)
Assessment of the Immunogenicity and Safety of a Dose-Sparing BioThrax® AVA Schedule
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…
- Trial name
- NCT01641991
- Testing
- BioThrax®
- Where
- 4 sites in United States
- Volunteers
- 328 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Anthrax
Safety and Pharmacokinetics Study of Human Monoclonal Antibody (AVP-21D9)
Primary: To compare the safety profile of a single intravenous administration of AVP-21D9 as compared with Placebo Secondary: To evaluate the pharmacokinetics (PK) of a single intravenous administration of AVP-21D9 To evaluate…
- Trial name
- NCT01202695
- Testing
- AVP-21D9
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Anthrax, Anthrax Immunisation
Anthrax AV7909 Liquid vs Lyophilized
This is a randomized, parallel-group, double-blind, Phase 1 study designed to assess safety, tolerability and immunogenicity 2 formulations of adjuvanted anthrax vaccine (AV7909), lyophilized and liquid.
- Trial name
- NCT04660201
- Testing
- AV7909
- Where
- United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Infections, Bacterial
Effect of Raxibacumab on Immunogenicity of Anthrax Vaccine Adsorbed
This study, as a post-marketing commitment to the Food and Drug Administration, is designed to detect the effect of raxibacumab on anthrax vaccine adsorbed (AVA) immunogenicity in a healthy volunteer population.
- Trial name
- NCT02339155
- Testing
- AVA, Raxibacumab, Diphenhydramine
- Where
- 3 sites in United States
- Volunteers
- 573 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Anthrax
Ph1 Study of Valortim and Ciprofloxacin in Humans
The purpose of this study is to evaluate the safety and tolerability of short-term dosing of IV ciprofloxacin when administered concomitantly with IV Valortim in healthy normal human subjects.
- Trial name
- NCT00964561
- Testing
- Ciprofloxacin and Valortim
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- PharmAthene, Inc.
Anthrax
A Study of Anthrax Vaccines Px563L and RPA563 in Healthy Adult Subjects
The trial investigates Px563L and RPA563, two formulations of a novel anthrax vaccine.
- Trial name
- NCT02655549
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Pfenex, Inc
Anthrax
Trial of rPA-102 Vaccine in Healthy Adult Volunteers
The purpose of this study is to assess the safety and immunogenicity of rPA102 vaccine given intramuscularly at 0 and 4 weeks over 2 dose ranges and 4 adjuvant levels.
- Trial name
- NCT00100724
- Testing
- rPA102
- Where
- 12 sites in United States
- Volunteers
- 480 people, healthy volunteers welcome
- Sponsor
- VaxGen
Study is Being Conducted in Healthy Volunteers
A Study to Assess How Much Drug Reaches the Blood When Given From Symbicort pMDI With Spacer Compared to That of Symbicort pMDI Without Spacer in Healthy Volunteers
This study will be conducted to establish the relative bioavailability of budesonide and formoterol delivered via Symbicort pressurized metered-dose inhaler (pMDI) with and without a spacer device.
- Trial name
- NCT02934607
- Testing
- Symbicort pMDI with spacer device, Symbicort pMDI without spacer device
- Where
- United Kingdom
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Anthrax
PA83-FhCMB Plant-Derived Recombinant Protective Antigen (rPA) Anthrax Vaccine
The purposes of this study is to evaluate and compare the safety, reactogenicity, and tolerability of the PA83-FhCMB vaccine candidate delivered at 4 dose levels with Alhydrogel
- Trial name
- NCT02239172
- Testing
- PA83-FhCMB
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Fraunhofer, Center for Molecular Biotechnology
Anthrax
Anthrax AV7909 Boost Evaluation Study
This randomized, phase 2, double-blinded, multicenter study is designed to assess the safety and immune response kinetics of CYFENDUS™ (henceforth AV7909) administered on 2 primary series vaccination schedules followed by 6- and…
- Trial name
- ABESt (NCT05997264)
- Testing
- AV7909 Full Dose (0.5 mL), AV7909 Half Dose (0.25 mL)
- Where
- 7 sites in United States
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- Biomedical Advanced Research and Development Authority
Healthy Volunteers
NasoShield Study of Safety and Immunogenicity
This study is a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation clinical trial to evaluate the safety and immunogenicity of NasoShield in healthy adults 18 to 49 years of age.
- Trial name
- NasoShield (NCT03352466)
- Testing
- NasoShield, BioThrax
- Where
- 2 sites in United States
- Volunteers
- 145 people, healthy volunteers welcome
- Sponsor
- Altimmune, Inc.
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)
Prevention of Bacillus Anthracis (Anthrax) Infection
Phase II Study of Range and Schedule of rPA Doses
This is a dose ranging study comparing different vaccine schedules of rPA vaccine for anthrax. Safety and the capability to induce an immune response will be evaluated.
- Trial name
- NCT00170456
- Testing
- rPA vaccine containing alhydrogel
- Where
- 2 sites in United Kingdom
- Volunteers
- 415 people, healthy volunteers welcome
- Sponsor
- PharmAthene UK Limited