NCT04578873

Phase 1 Oral QPX7831 SAD and MAD in Healthy Adults

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Qpex Biopharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Bacterial Infections

Interventions

Type	Name	Description
DRUG	QPX7831	capsule
DRUG	placebo comparator	oral matched placebo capsule

Timeline

• Start date: 2021-04-13
• Primary completion: 2022-08-30
• Completion: 2022-08-30
• First posted: 2020-10-08
• Last updated: 2022-10-10

Locations

2 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study