drugset / Trial / NCT04808414
SAD/MAD Safety and PK Study of QPX9003 (Novel Polymyxin) in Normal Healthy Volunteers
Phase 1
Completed
104 enrolled
Qpex Biopharma, Inc.
Biomedical Advanced Research and Development Authority · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
The worldwide spread of resistance to antibiotics among gram-negative bacteria, particularly members of the ESKAPE group of pathogens, has resulted in a crisis in the treatment of hospital acquired infections. In particular, the presence of multi-drug resistant Acinetobacter baumannii and Pseudomonas aeruginosa in hospitals around the world poses a considerable threat. .
Timeline
- Start
- 2021-06-03
- Primary completion
- 2022-07-14
- Completion
- 2022-07-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | QPX9003 | Unknown | 10 mg | Intravenous |
| Subject | QPX9003 | Unknown | 100 mg | Intravenous |
| Subject | QPX9003 | Unknown | 150 mg | Intravenous |
| Subject | QPX9003 | Unknown | 200 mg | Intravenous |
| Subject | QPX9003 | Unknown | 400 mg | Intravenous |