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NCT06741345 · ClinicalTrials.gov registry record · Phase 1
Phase 1 BIO 300 Oral Suspension
A Phase 1 study, sponsored by Humanetics Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
NCT06741345: Completed Phase 1 study, sponsored by Humanetics Corporation.
NCT06741345 is a Phase 1 study that has completed, run by Humanetics Corporation. The registered enrollment target is 56 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06741345, a Phase 1 study, has completed, sponsored by Humanetics Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
Study Summary
This is a two-part study of BIO 300 Oral Suspension in healthy male and female volunteers. The first part is a multiple ascending dose (MAD) study to test the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of the drug when given as daily doses over 14 days. The study will enroll three cohorts each receiving a different daily dose: 2000 mg, 3000 mg, or 4000 mg. A fourth group may be added depending on results on the first three cohorts. Each cohort will include 10 participants (5 men, 5 women), with at least 8 completing all study steps. Participants will follow a special diet low in soy-based foods and will fast before certain doses. Blood samples and health checks will be done throughout the study to assess safety, drug is absorption and distribution in the body (PK), and its effects (PD). Safety will be reviewed after each group finishes to decide if the next dose level is safe to proceed. The second part of the study is a food effect study to examine how food effects the PK of a single dose of BIO 300 Oral Suspension. This study will enroll 16 participants (8 men, 8 women) and will be split into two groups: one group will take the drug after fasting for 10 hours and the other will take the drug after eating a high-fat meal. After a 7-day break, participants will switch conditions (the previously fasted group will take the drug with food, and the previously fed group will take the drug after fasting). Blood samples and health checks will measure how food influences drug absorption (PK) and safety. Both the MAD study and food effect study aim to ensure the drug is safe and provide data on how it behaves in the body under different conditions.
Primary Outcome
Report the incidence and severity of BIO 300 Oral Suspension-related adverse events following 14 days of once daily administration and single doses administered under fed vs fasted conditions as assessed by CTCAE v5.0
Interventions
- DRUG BIO 300 Oral Suspension
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2024-12-23 |
| Est. Completion | 2025-08-15 |
| Phase | Phase 1 |
What the finished NCT06741345 record still lists
NCT06741345 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which BIO 300 Oral Suspension is the first listed.
NCT06741345 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06741345 about?
NCT06741345 is a clinical study titled "Phase 1 BIO 300 Oral Suspension". This is a two-part study of BIO 300 Oral Suspension in healthy male and female volunteers. The first part is a multiple ascending dose (MAD) study to test the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of the drug when given as daily doses over 14 days. The study will enroll three cohor...
What is the current status of trial NCT06741345?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2024-12-23. Estimated completion is 2025-08-15.
What interventions are being tested in trial NCT06741345?
The interventions under investigation include: BIO 300 Oral Suspension (DRUG).
Who is sponsoring clinical trial NCT06741345?
This trial is sponsored by Humanetics Corporation, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06741345's enrollment target sits among peer trials
56 902nd of 2000 higher than 1,083 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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