Acinetobacter Baumannii Infection Clinical Trial
Official title:
A Phase I, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Intravenous ETX2514 Administered in Healthy Subjects
This research project is being conducted to look at the safety, tolerability, and
pharmacokinetics (PK; how the human body processes a substance) of ETX2514 when given to
healthy volunteers intravenously as a single dose, and when given as multiple intravenous
doses for up to 8 consecutive days.
As it is anticipated that ETX2514 could be used as a treatment for Acinetobacter baumannii
(a type of bacteria) infections, this project will also look at whether ETX2514 will
interact with the current treatments for these infections when they are administered at the
same time.
This Phase 1, single-center, randomized, double-blind, and placebo-controlled study
investigates the safety, tolerability, and PK profile of single and multiple ascending doses
of intravenous (IV) ETX2514 when administered intravenously alone and in combination with
sulbactam and/or imipenem/cilastatin in healthy adult participants.
The study will be conducted in four Parts: A, B, C, and D. Part A will explore the safety
and tolerability of a single ascending dose (SAD) of IV ETX2514 over 8 cohorts. Part B will
explore the safety and tolerability of multiple ascending doses (MAD) of IV ETX2514 over 4
cohorts. Part C will explore the safety and tolerability of IV ETX2514 when administered as
a single dose in combination with sulbactam (1.0 gram [g]) and/or imipenem/cilastatin (0.5
g) to healthy participants over 2 cohorts. Part D will explore the safety and tolerability
of multiple doses of combined IV ETX2514/sulbactam (1.0 g)/imipenem/cilastatin (0.5 g) to
healthy participants.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03310463 -
Evaluation of the Pharmacokinetics, Safety, and Tolerability of Intravenous ETX2514 and Sulbactam Administered Concurrently to Subjects With Various Degrees of Renal Impairment and Healthy Matched Control Subjects
|
Phase 1 | |
| Completed |
NCT02886637 -
Effects of Immune Function on Prognositic Outcome in Critical Ill Patients With Acinetobacter Baumannii Infection
|
N/A | |
| No longer available |
NCT04636554 -
Personalized Phage Treatment in Covid-19 Patients With Bacterial Co-Infections Microbials for Pneumonia or Bacteremia/Septicemia
|