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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 is a Phase 1 study that has completed, run by Humanetics Corporation. The registered enrollment target is 56 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06741345
The ClinicalTrials.gov registry entry for NCT06741345 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Humanetics Corporation, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which BIO 300 Oral Suspension is the first listed.
NCT06741345 reports 0 study locations.
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.
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