drugset / Trial / NCT04650555
BIO 300 Oral Powder Safety and Pharmacokinetics
Phase 1
Completed
34 enrolled
Humanetics Corporation
Joint Warfighter Medical Research Program · collabUnited States Department of Defense · collab
Non-randomizedSequentialOpen-labelPrevention
Summary
Open-label, single ascending dose and multiple single dose study in healthy volunteers to evaluate the safety and pharmacokinetics of BIO 300 Oral Powder (BIO 300). The single ascending dose study consists of 4 ascending dose cohorts and the multiple single dose study consists of a single dose given daily for 6 consecutive days.
Timeline
- Start
- 2020-12-08
- Primary completion
- 2021-07-06
- Completion
- 2021-07-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Genistein | Other / unclassified | 500 mg | Oral |
| Subject | Genistein | Other / unclassified | 1000 mg | Oral |
| Subject | Genistein | Other / unclassified | 2000 mg | Oral |
| Subject | Genistein | Other / unclassified | 3000 mg | Oral |