Phase 1 BIO 300 Oral Suspension

Phase 1

Recruiting

• Conditions: Healthy Volunteer Study
• Interventions: Drug: BIO 300 Oral Suspension

• Registration Number: NCT06741345
• Lead Sponsor: Humanetics Corporation

Brief 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.

Detailed Description

Part 1: Multiple Ascending Dose Study (MAD): Open-label, ascending dose given once daily for 14 days in healthy volunteers. The study will enroll 3 cohorts (dose levels) sequentially, each with 10 participants (5F/5M) per cohort, so that a minimum of 8 study participants (4F/4M) per cohort complete all study procedures. Participants will follow a diet low in soy isoflavones for 7 days before, during and 7 days after treatment and will be required to fast at least 10 hours before the first, sixth and last dose. BIO 300 Oral Suspension will be administered starting on day 1. The first cohort, Cohort 1, will be administered BIO 300 Oral Suspension at 2000 mg/day once daily for 14 days. If dose escalation criteria are met, Cohort 2 will be administered 3000 mg/day, and similarly if dose escalation criteria are met following Cohort 2, then Cohort 3 will be administered 4000 mg/day. Following the completion of Cohort 3, there will be an option to enroll a fourth cohort at a higher or lower dose depending on the outcomes of the first three cohorts. Participants will be administered BIO 300 Oral Suspension daily during their scheduled clinic visits. Participants will remain in the clinic 12 hours after the first dose, sixth dose and last dose and for observations and blood sample collection for clinical lab assessment, pharmacokinetics (PK) and pharmacodynamics (PD). On the day 1, 6 and 14, participants will remain fasted after dosing for 4 hours until provided a standardized low soy meal after the 4 hour blood draw and after the 8 hour blood draw. Blood sampling and/or observations will be performed on dosing days 1-14 as described in the schedule of events. Participants will return to the clinic on days 15, 16 and 21 after their final dose for blood sampling and/or observations as detailed in the schedule of events. Safety data will be reviewed after the completion of each cohort to approve dose escalation. At the conclusion of all three cohorts, all data will be analyzed to assess safety, PK and PD. If the optional fourth cohort is enrolled, all data (safety, PK and PD) from the fourth cohort will be analyzed at the conclusion of the cohort.

Part 2: Food Effect Study: Following the MAD study, an open-label, single-dose food effect study in healthy volunteers will be conducted. The study will enroll 16 participants (8F/8M), so that a minimum of 12 study participants (6F/6M) complete all study procedures. Study participants will be randomized 1:1 into two cohorts. Cohort 1 will be administered a single BIO 300 Oral Suspension dose under fasted conditions and Cohort 2 will be administered a single BIO 300 Oral Suspension dose under fed conditions. After a 7 day washout period, participants in cohort 1 will receive another dose of BIO 300 Oral Suspension under fed conditions and participants in cohort 2 will receive another dose of BIO 300 Oral Suspension under fasted conditions (cross over design). All participants will follow a diet low in soy isoflavones for 7 days before dosing, during the washout period and for 7 days after dosing. The planned BIO 300 Oral Suspension dose used in this study will be 3000 mg, however this is subject to change following safety and PK data review following the completion of the MAD study above. For fasted dosing, participants will be required to fast for at least 10 hours prior to dosing and for 4 hours after dosing. For fed dosing, participants will receive an FDA-approved high-fat meal with no substitutions (800-1000 calories; approximately 50% of calories derived from fat) following an overnight fast of at least 10 hours. The entire meal will be consumed within 30 minutes, dosing will begin 30 minutes after starting the meal, and participants will fast for 4 hours after dosing. All participants will remain in the clinic 12 hours after each dose for observations and blood sample collection for clinical lab assessment, and PK. All participants will remain fasted (fasted cohort) or fast (fed cohort) after dosing for 4 hours until provided a standardized low soy meal after the 4 hour blood draw and after the 8 hour blood draw. Participants will return to the clinic on day 2 and 3 after dosing for blood sampling and/or observations as detailed in the schedule of events (day 10 and 11 after the second dose). At the conclusion of the study, data will be analyzed from both cohorts to determine safety and PK.

Study Timeline

• Study First Submitted: 2024-12-11
• Study First Submitted QC: 2024-12-16
• Study First Posted: 2024-12-18
• Study Start: 2024-12-23
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-10
• Last Update Posted: 2025-01-14
• Primary Completion: 2025-07-18
• Study Completion: 2025-07-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Multiple Ascending Dose	BIO 300 Oral Suspension	The multiple ascending dose study has a single arm. Three cohorts are enrolled sequentially and given ascending doses of study intervention.
Food Effect: Fed-Fasted Arm	BIO 300 Oral Suspension	Food effect study arm that is administered the study intervention first under fed conditions and then under fasted conditions following crossover.
Food Effect: Fasted-Fed	BIO 300 Oral Suspension	Food effect study arm that is administered the study intervention first under fasted conditions and then under fed conditions following crossover.

Primary Outcome Measures

Name	Time	Method
Describe the overall adverse event profile of BIO 300 Oral Suspension in healthy volunteers following repeat dosing or single doses under fed and fasted conditions	Up to 7 days after the last dose	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

Secondary Outcome Measures

Name	Time	Method
Describe the effects of multiple ascending doses of BIO 300 Oral Suspension on protein expression in the blood as assessed by proximity extension assay	From enrollment to the end of treatment at 14 days	Assess changes in protein expression in the blood serum related to BIO 300 Oral Suspension after 1, 6 and 14 days of dosing.
Describe the effects of multiple ascending doses of BIO 300 Oral Suspension on gene expression in the blood as assessed by RNA sequencing	From enrollment to the end of treatment at 14 days	Assess changes in differential gene expression in the whole blood related to BIO 300 Oral Suspension after 1, 6 and 14 days of dosing.
Identify serum metabolites of genistein after single and repeat doses of BIO 300 Oral Suspension under fed or fasted conditions	From enrollment to 48 hours after the last dose	Report the serum metabolites of genistein and their relative abundance after 1 or 14 days of dosing
Evaluate the potential for BIO 300 Oral Suspension to prolongate the corrected QT (QTc) interval following single and repeat doses	From enrollment to 24 hours after the first dose and the last dose	Change in QTc interval relative to baseline following a single dose and 14 repeat doses of BIO 300 Oral Suspension
Establish the PK of single and repeat doses of BIO 300 Oral Suspension under fed or fasted conditions	48 hours after the last dose	Report half-life (T1/2) after 14 once daily doses

Trial Locations

Locations (1)

Nucleus Network, LLC; 🇺🇸 Saint Paul, Minnesota, United States