Phase 1 Oral QPX7831 SAD and MAD in Healthy Adults
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 136
Summary
- Conditions
- Bacterial Infections
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: Double-blind, placebo-controlled, sequential, ascending single-and multiple-dose designMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: matched oral placebo capsulePrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 55 years
- Gender
- Both males and females
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: To assess the safety and tolera...
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: 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. 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.
Tracking Information
- NCT #
- NCT04578873
- Collaborators
- Biomedical Advanced Research and Development Authority
- Investigators
- Study Director: Jeffery Loutit, MBChB Qpex Biopharma, Inc.
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