Velocity 2: An Anthrax Vaccine and Antibiotics Clinical Study
NCT04067011 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 210
Last updated 2025-09-08
Summary
This study is designed to evaluate the pharmacokinetic (PK) profiles of ciprofloxacin or doxycycline when administered orally, prior to, and following, the intramuscular (IM) administration of a two-dose schedule of AV7909 administered two weeks apart.
Conditions
- Anthrax
Interventions
- DRUG
-
Ciprofloxacin 500Mg Tablet
Ciprofloxacin 500mg administered by mouth every 12 hours. The antibiotic will be administered orally on Study Days 4-9, 22-24 and 31-37.
- DRUG
-
Doxycycline 100Mg Tablet
Doxycycline 100mg administered by mouth every 12 hours. The antibiotic will be administered orally on Study Days 2-9, 22-24 and 32-38.
- BIOLOGICAL
-
AV7909
0.5mL AVA and 0.25mg CPG 7909 per 0.5mL dose.The vaccine will be administered intramuscularly on Study Days 8 and 23.
Sponsors & Collaborators
-
Biomedical Advanced Research and Development Authority
collaborator FED -
Emergent BioSolutions
lead INDUSTRY
Principal Investigators
-
Bojan Drobic · Emergent BioSolutions
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-08-12
- Primary Completion
- 2020-03-05
- Completion
- 2020-03-19
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Pharmacokinetic Study of Oral Gepotidacin (GSK2140944) in Subjects With Uncomplicated Urinary Tract Infection (Acute Cystitis)
NCT03568942 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, Tolerability and PK of Intravenous (IV) ETI-204 Alone and in Presence of Ciprofloxacin in Adult Volunteers
NCT01952444 ·Status: COMPLETED ·Phase: PHASE1
-
A Randomized, Single Blind, Placebo Controlled Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Oral Doses and Repeat Escalating Oral Doses of GSK2251052 in Healthy Adult Subjects
NCT01262885 ·Status: COMPLETED ·Phase: PHASE1
-
FiH Study to Assess Safety and PK of SAD and MAD of ANT3310 Alone and in Combination With Meropenem in Healthy Subjects
NCT05905913 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)
NCT06749457 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of RO7079901 and the Combination of RO7079901 With Meropenem in Adult Healthy Volunteers
NCT02972255 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, Pharmacokinetics of Intravenous RPX2003 (Biapenem) in Healthy Adult Subjects
NCT01702649 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Safety and Effect of STC3141 Continuous Infusion in Subjects With Severe Corona Virus Disease 2019(COVID-19)Pneumonia
NCT04880694 ·Status: COMPLETED ·Phase: PHASE2
-
Phase 1 Randomized Double-blind Placebo Controlled Study to Evaluate Safety and PK of MEDI3902 in Healthy Adults
NCT02255760 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Determine the Excretion and Metabolism of 14C-ETX2514 Administered Intravenously in Healthy Male Subjects
NCT04018950 ·Status: COMPLETED ·Phase: PHASE1
-
An Effectiveness, Safety, and Microbiology Study of Doripenem in Patients With Nosocomial (Hospital-acquired) Pneumonia
NCT00502801 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, Tolerability and Pharmacokinetics of Aerosolized Amikacin in Intubated and Mechanically-ventilated Patients With Nosocomial Pneumonia
NCT01021436 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Investigate the Intrapulmonary Lung Penetration of Nacubactam in Healthy Participants
NCT03182504 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health
NCT03819049 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Effort to Prevent Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa in Mechanically Ventilated Subjects
NCT02696902 ·Status: COMPLETED ·Phase: PHASE2
-
Aerosolized and Intravenous Colistin in Healthy Adults
NCT01863719 ·Status: TERMINATED ·Phase: PHASE1
-
A Study to Investigate the Pharmacokinetics of RO7079901 and Meropenem in Participants With a Complicated Urinary Tract Infection
NCT03174795 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in Carbapenem-Resistant Enterobacteriaceae Infections
NCT07089186 ·Status: RECRUITING ·Phase: PHASE3
-
Evaluating the Plasma, Epithelial Lining, and Alveolar Macrophage Concentrations of Intravenous Carbavance™ (RPX2014/RPX7009) in Healthy Adult Subjects
NCT02073812 ·Status: COMPLETED ·Phase: PHASE1
-
Inhaled Amikacin Solution BAY41-6551 as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia
NCT01799993 ·Status: COMPLETED ·Phase: PHASE3
-
Prevention of S. Aureus Pneumonia Study in Mechanically Ventilated Subjects Who Are Heavily Colonized With S. Aureus.
NCT02940626 ·Status: TERMINATED ·Phase: PHASE2
-
Phase 1 Study to Evaluate DDI, PK, Safety, Tolerability of SPR741
NCT03376529 ·Status: COMPLETED ·Phase: PHASE1
-
A Study Investigating the Safety, Recovery, and Pharmacodynamics of Multiple Oral Administrations of SNIPR001 in Healthy Subjects
NCT05277350 ·Status: COMPLETED ·Phase: PHASE1
-
PK of BV100 in Patients VABP Suspected or Confirmed to Be Due to CRAB
NCT05685615 ·Status: COMPLETED ·Phase: PHASE2
-
Safety Study of Intravenous Biapenem (RPX2003) and RPX7009 Given Alone and in Combination
NCT01772836 ·Status: COMPLETED ·Phase: PHASE1