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Phase 1 Oral QPX7831 SAD and MAD in Healthy Adults

Bacterial Infections Clinical Trial

Official title:
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single- and Multiple-Dose Study of the Safety, Tolerability, and Pharmacokinetics of Oral QPX7831 in Healthy Adult Subjects

Clinical Trial Summary

This Phase 1 study will assess the safety, tolerability, and pharmacokinetics (PK) of QPX7831, a beta-lactamase inhibitor, when administered orally in single ascending doses and in multiple ascending doses to heathy adult subjects.

Clinical Trial Description

Qpex Biopharma, Inc. is developing an oral dosage form that delivers QPX7728, a new boron-based beta-lactamase inhibitor with activity against both serine and metallo-beta-lactamases, for oral treatment in combination with a beta-lactam antibiotic. The objectives are: 1. To assess the safety and tolerability of QPX7831 when administered orally in single ascending doses (SAD) and in multiple ascending doses (MAD) to healthy adult subjects. 2. To assess the PK of single and multiple doses of oral QPX7831 when administered to healthy adult subjects to determine if the target exposures identified in preclinical studies can be attained in healthy adult subjects. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04578873
Study type Interventional
Source Qpex Biopharma, Inc.
Contact
Status Completed
Phase Phase 1
Start date April 13, 2021
Completion date August 30, 2022
View Details
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