Trials / Completed
CompletedNCT04650555
BIO 300 Oral Powder Safety and Pharmacokinetics
A Phase 1 Dose Escalation Trial Evaluating the Safety and Pharmacokinetic Profile of BIO 300 Oral Powder in Healthy Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 34 (actual)
- Sponsor
- Humanetics Corporation · Industry
- Sex
- All
- Age
- 18 Years – 64 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BIO 300 Oral Powder | Amorphous solid dispersion of genistein milled into a powder |
Timeline
- Start date
- 2020-12-08
- Primary completion
- 2021-07-06
- Completion
- 2021-07-06
- First posted
- 2020-12-02
- Last updated
- 2024-05-03
- Results posted
- 2024-05-03
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04650555. Inclusion in this directory is not an endorsement.