Phase 1 BIO 300 Oral Suspension

NCT06741345 | Completed Phase 1 FDA Drug

• 2 other identifiers: CL0111-01W911SR-23-9-0018
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer Study

Keywords

healthy volunteer; BIO 300 Oral Suspension; Genistein; acute radiation syndrome; radiation; radioprotection; pharmacokinetics; pharmacodynamics; multiple ascending dose; food effect; safety; medical countermeasure

Outcome Measures

Primary Outcomes (1)

• 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

  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

  Up to 7 days after the last dose

Secondary Outcomes (17)

• 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

• 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

• 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

• 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 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

Study Arms (3)

Multiple Ascending Dose

EXPERIMENTAL

The multiple ascending dose study has a single arm. Three cohorts are enrolled sequentially and given ascending doses of study intervention.

Drug: BIO 300 Oral Suspension

Food Effect: Fed-Fasted Arm

EXPERIMENTAL

Food effect study arm that is administered the study intervention first under fed conditions and then under fasted conditions following crossover.

Drug: BIO 300 Oral Suspension

Food Effect: Fasted-Fed

EXPERIMENTAL

Food effect study arm that is administered the study intervention first under fasted conditions and then under fed conditions following crossover.

Drug: BIO 300 Oral Suspension

Interventions

BIO 300 Oral Suspension DRUG

Suspension of genistein nanoparticles for oral administration

Also known as: genistein nanosuspension

Food Effect: Fasted-Fed; Food Effect: Fed-Fasted Arm; Multiple Ascending Dose

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult, 18-64 years old.
• BMI 18-30 kg/m2
• No ingestion of prescription or over-the-counter medications (including dietary and herbal supplements) for 7 days prior to first dose of study drug and no planned use during study participation. Acetaminophen of up to 3 g/day and ibuprofen up to 1 g/day will be allowed at discretion of the Investigator.
• At the discretion of the Investigator, blood routine, liver and kidney functions are within the controllable range.
• Adequate hepatic function as evidenced by ALT, AST or LDH \< 1.25X ULN and bilirubin \< 1.5X ULN for the reference lab.
• Adequate renal function as evidenced by a serum creatinine ≤ 1.5 X ULN for the reference laboratory OR a calculated creatinine clearance of ≥ 60 mL/min by the estimated glomerular filtration rate (eGFR).
• Adequate hematopoietic function as evidenced by white blood cells ≥ 3x109 / L and platelets ≥ 100x109 / L.
• Female study participants must have a negative pregnancy test within 72 hours of the start of treatment.
• Study participants must agree to abstain from heterosexual intercourse or use an effective method of contraception for 7 days after their last dose. Study participants using hormonal contraception are required to utilize double barrier contraception method for 7 days after their last dose.
• No nicotine use for 30 days prior to first dose, confirmed by negative cotinine test on day 1.
• Study participant must agree to abstain from THC use from screening to day 1 and for the duration of the study and agree to abstain from alcohol starting 48 hours prior to day 1 and for the duration of the study.
• Ability to read and provide written informed consent.
• Study participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, dietary restrictions, and other study procedures.
• No clinically significant abnormalities identified by medical history, physical examination, vital signs, ECG, and clinical laboratory tests in the opinion of the Investigator.

You may not qualify if:

• Any prior use of the study test article, BIO 300 Oral Suspension, or the related test article BIO 300 Oral Powder.
• Any known allergies to the study test article and its components (i.e., parabens)
• Any clinically significant weight loss any time in prior 4 weeks at discretion of Investigator based on medical history interview.
• Study participants with any of the following are not eligible;
• Previous history of QTc prolongation resulting from "known-risk" medications (www.Crediblemeds.org) that required discontinuation of that medication;
• Congenital long QT syndrome, or 1st degree relative with unexplained sudden death under 40 years of age;
• Presence of left bundle branch block (LBBB);
• QTc with Fridericia's correction (QTcF) that is unmeasurable, or \> 480 msec on screening or Day 1 pre-dose ECG. The average QTcF from the screening and Day 1 pre-dose ECG (completed in triplicate) must be ≤ 480 msec in order for the study participant to be eligible for the study. Based on the initial triplicate results, if in the opinion of the Investigator it is warranted, the screening or Day 1 pre-dose ECG can be repeated one time in triplicate to determine study participant eligibility.
• Study participants with a history of arrhythmia (multifocal premature ventricular contractions (PVCs), bigeminy, trigeminy, ventricular tachycardia, or atrial fibrillation) which is symptomatic or requires treatment (CTCAE Grade 3) or asymptomatic sustained ventricular tachycardia are not eligible.
• Psychiatric conditions, social situations or substance abuse that precludes the ability of the study participant to cooperate with the requirements of the trial and protocol therapy at Investigator discretion.
• Inability to refrain from alcohol consumption for 48 hours prior to day 1 and for the duration of the study or THC use from screening to day 1 and for the duration of the study. Illicit drugs must be avoided from screening through the duration of the study.
• Positive results for Hep B surface antigen, Hep C antibody, or HIV 1/2 antibody at screening visit. Positive Hep C antibody test allowed if reflex test is negative.
• Clinically significant immunodeficiency disorder in the opinion of the Investigator.
• Pregnancy or women and men who are sexually active and not willing/able to use effective methods of contraception.
• Participants who are actively breastfeeding are not eligible for this study.

Sponsors & Collaborators

• Humanetics Corporation: lead

Study Sites (1)

Nucleus Network, LLC

Saint Paul, Minnesota, 55114, United States

Location

Related Links

• Sponsor's Company Website

MeSH Terms

Conditions

Acute Radiation Syndrome

Condition Hierarchy (Ancestors)

Radiation Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multiple ascending dose study will enroll three cohorts sequentially. An optional fourth cohort may be enrolled. The food effect study follows a randomized, balanced, single-dose, two-treatment (i.e., fed versus fasted), two-period, crossover design.

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 18, 2024
• Study Start: December 23, 2024
• Primary Completion: August 15, 2025
• Study Completion: August 15, 2025
• Last Updated: October 30, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning at the time of results publication with no end date

Locations

US (1)