Testing BIO 300 Oral Suspension in healthy volunteers

A Phase 1 Multiple Ascending Dose and Food Effect Trial of BIO 300 Oral Suspension in Healthy Volunteers

This study is testing a new oral medication called BIO 300 in healthy adults to see how safe it is and how it works in the body, including how food might change its effects.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (estimated)
• Ages: 18 Years to 64 Years
• Sex: All
• Sponsor: Humanetics Corporation (Industry-sponsored)
• Locations: 1 site (Saint Paul, Minnesota)
• Trial ID: NCT06741345 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effects of BIO 300 Oral Suspension in healthy adults through a two-part approach. The first part involves a multiple ascending dose (MAD) study where participants receive daily doses of the drug for 14 days, with cohorts receiving different dosages. Participants will follow a specific diet and undergo health checks and blood sampling to assess the drug's pharmacokinetics and pharmacodynamics. The second part will investigate how food affects the drug's absorption and effects.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18-64 with a BMI between 18-30 who are not taking any medications.

Not a fit: Patients with underlying health conditions or those taking medications that could interfere with the study will not benefit from participation.

Why it matters

Potential benefit: If successful, this study could provide insights into the safety and efficacy of BIO 300 Oral Suspension, potentially benefiting future treatments for conditions like acute radiation syndrome.

How similar studies have performed: While this approach is novel in its specific application, similar studies have shown promise in assessing the safety of new oral medications.

Eligibility criteria

INCLUSION: In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Healthy adult, 18-64 years old.
2. BMI 18-30 kg/m2
3. 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.
4. At the discretion of the Investigator, blood routine, liver and kidney functions are within the controllable range.

   1. Adequate hepatic function as evidenced by ALT, AST or LDH \< 1.25X ULN and bilirubin \< 1.5X ULN for the reference lab.
   2. 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).
   3. Adequate hematopoietic function as evidenced by white blood cells ≥ 3x109 / L and platelets ≥ 100x109 / L.
5. Female study participants must have a negative pregnancy test within 72 hours of the start of treatment.
6. 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.
7. No nicotine use for 30 days prior to first dose, confirmed by negative cotinine test on day 1.
8. 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.
9. Ability to read and provide written informed consent.
10. Study participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, dietary restrictions, and other study procedures.
11. No clinically significant abnormalities identified by medical history, physical examination, vital signs, ECG, and clinical laboratory tests in the opinion of the Investigator.

EXCLUSION: An individual who meets any of the following criteria will be excluded from participation in this study:

1. Any prior use of the study test article, BIO 300 Oral Suspension, or the related test article BIO 300 Oral Powder.
2. Any known allergies to the study test article and its components (i.e., parabens)
3. Any clinically significant weight loss any time in prior 4 weeks at discretion of Investigator based on medical history interview.
4. Study participants with any of the following are not eligible;

   1. Previous history of QTc prolongation resulting from "known-risk" medications (www.Crediblemeds.org) that required discontinuation of that medication;
   2. Congenital long QT syndrome, or 1st degree relative with unexplained sudden death under 40 years of age;
   3. Presence of left bundle branch block (LBBB);
   4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. Clinically significant immunodeficiency disorder in the opinion of the Investigator.
10. Pregnancy or women and men who are sexually active and not willing/able to use effective methods of contraception.
11. Participants who are actively breastfeeding are not eligible for this study.
12. Study participants that consume a soy-rich diet in the opinion of the Investigator such as participants that are vegan or vegetarian.
13. Any history of systemic infection requiring hospitalization, systemic antibiotics, or as judged clinically significant by the Investigator in the 3 months prior to day 1.
14. Any condition possibly affecting drug absorption (e.g., prior bariatric surgery, gastrectomy, intestinal resection). Participants who have undergone appendectomy or cholecystectomy are allowed so long as the surgery occurred more than 6 months prior to day 1.
15. Treatment with another investigational drug within 30 days or 5 half-lives (whichever is longer) proceeding Day 1 and during the duration of the study.
16. Positive drug screen or alcohol test at screening and day 1 predose. Positive THC screen allowed at screening but must be negative on day 1.
17. Blood donation of approximately 1 pint (500 ml) or more within 60 days of day 1; plasma donations within 14 days of day 1. Study participants must agree not to donate blood or plasma for the duration of the study and for 7 days following the end of study procedures.
18. Study participants must agree not to donate ova (eggs) or sperm for the duration of the study and for 7 days following the last dose of study drug.
19. Inability to swallow liquid medication.
20. History of sensitivity to heparin or heparin-induced thrombocytopenia.
21. Participants recruited for the food effect study that cannot consume the entire standardized high fat meal without substitutions.
22. Any chronic condition that requires daily medication
23. Considered by the Investigator to be unsuitable to participate in the study for any other reason.

Where this trial is running

Saint Paul, Minnesota

• Nucleus Network, LLC — Saint Paul, Minnesota, United States (Recruiting)

Study contacts

• Study coordinator: Vice President of Research and Development

Conditions Healthy Volunteer Study; healthy volunteer; BIO 300 Oral Suspension; Genistein; acute radiation syndrome; radiation; radioprotection; pharmacokinetics