Phase 1 BIO 300 Oral Suspension
Public ClinicalTrials.gov record NCT06741345. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1 Multiple Ascending Dose and Food Effect Trial of BIO 300 Oral Suspension in Healthy Volunteers
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06741345
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 56 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 64 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 22, 2024
- Primary completion
- Aug 14, 2025
- Completion
- Aug 14, 2025
- Last update posted
- Oct 29, 2025
2024 – 2025
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Nucleus Network, LLC | Saint Paul | Minnesota | 55114 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06741345, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 29, 2025 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06741345 live on ClinicalTrials.gov.