BIO 300 Oral Suspension for Healthy Volunteers

Overseen By Vice President of Research and Development

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Humanetics Corporation

Must not be taking: Prescription medications

Disqualifiers: Arrhythmia, QTc prolongation, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 16

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and behavior of a new liquid medication, BIO 300 Oral Suspension, in healthy adults. Researchers seek to understand how the body absorbs and processes the drug, both with and without food. The trial includes individuals who are generally healthy and do not regularly use medications, tobacco, or THC. Participants must follow a specific diet and avoid certain substances during the study. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any prescription or over-the-counter medications, including dietary and herbal supplements, for 7 days before the study starts and during the study. However, acetaminophen and ibuprofen are allowed in limited amounts at the discretion of the Investigator.

Is there any evidence suggesting that BIO 300 Oral Suspension is likely to be safe for humans?

Research has shown that BIO 300 Oral Suspension was safe in earlier studies. For example, one study found that doses up to 200 mg/kg were safe in animals similar to humans, which is promising because these animals often react like humans in early tests. Additionally, when combined with standard lung cancer treatments, BIO 300 was safe and well-tolerated.

While these results are promising, it's important to remember that this trial is in an early stage. Early trials focus on checking safety in humans, so the treatment is still being studied to confirm these initial findings. Participants in this trial will help researchers learn how well BIO 300 is tolerated, especially at different doses and whether taken with or without food. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

BIO 300 Oral Suspension is unique because it explores new possibilities in drug delivery and bioavailability. Unlike other treatments that might require intravenous administration, BIO 300 is taken orally, potentially increasing convenience and adherence. Researchers are also interested in understanding how food affects its absorption, which could lead to optimized dosing recommendations. This focus on the oral suspension form and food interaction could make it stand out by offering more flexible and user-friendly treatment options.

What evidence suggests that BIO 300 Oral Suspension could be effective?

Research has shown that BIO 300 Oral Suspension might protect the body from radiation damage. In studies with patients receiving radiation therapy for non-small cell lung cancer, BIO 300 helped lessen side effects. Animal studies also support its potential benefits; for example, BIO 300 significantly protected mice from radiation. These findings suggest that BIO 300 could shield the body from radiation damage, making it a promising treatment for further exploration. In this trial, healthy volunteers will participate in different study arms to evaluate the effects of BIO 300 under various conditions, including multiple ascending doses and food effect studies. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for healthy men and women who can follow a special diet low in soy-based foods. Participants must be willing to fast before doses and commit to the study schedule, including blood samples and health checks. Those with allergies or conditions affecting drug absorption are likely excluded.

Inclusion Criteria

BMI 18-30 kg/m2

No clinically significant abnormalities identified by medical history, physical examination, vital signs, ECG, and clinical laboratory tests in the opinion of the Investigator

I have taken a pregnancy test within the last 3 days and it was negative.

Exclusion Criteria

Clinically significant immunodeficiency disorder in the opinion of the Investigator

I tested positive for Hep B, Hep C, or HIV but my Hep C follow-up test was negative.

Participants recruited for the food effect study that cannot consume the entire standardized high fat meal without substitutions

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Multiple Ascending Dose (MAD) Study

Participants receive ascending doses of BIO 300 Oral Suspension daily for 14 days to assess safety, PK, and PD.

14 days

Daily visits for 14 days, with additional visits on days 15, 16, and 21

Food Effect Study

Participants receive a single dose of BIO 300 Oral Suspension under fed and fasted conditions to assess the effect of food on PK.

Approximately 2 weeks including washout period

Visits on dosing days and follow-up on days 2 and 3 after each dose

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 7 days after the last dose

What Are the Treatments Tested in This Trial?

Interventions

• BIO 300 Oral Suspension

Trial Overview The trial tests BIO 300 Oral Suspension's safety and how it's processed by the body (PK/PD) over daily doses for two weeks at varying strengths (2000 mg, 3000 mg, or possibly up to 4000 mg). It also examines how food affects the drug's absorption with participants trying both fasting and fed conditions.

How Is the Trial Designed?

Group I: Multiple Ascending Dose Experimental Treatment 1 Intervention

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

Group II: Food Effect: Fed-Fasted Arm Experimental Treatment 1 Intervention

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

Group III: Food Effect: Fasted-Fed Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Humanetics Corporation

Lead Sponsor

Trials

8

Recruited

300+

Published Research Related to This Trial

Biosimilars, while similar in efficacy to reference drugs, may have different safety profiles, particularly concerning adverse reactions, necessitating ongoing monitoring after approval.

The European Medicines Agency requires biosimilar applicants to submit a risk management plan and pharmacovigilance program to address potential safety issues, especially immunogenicity, throughout the drug's lifecycle.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biosimilars: pharmacovigilance and risk management. Zuñiga, L., Calvo, B.[2013]

In a study of 133 approved generic formulations of BCS Class III drugs, only 30.08% met the stringent formulation criteria for qualitative (Q1) sameness and quantitative (Q2) similarity, yet all formulations demonstrated bioequivalence in terms of absorption parameters (AUC and Cmax).

The results suggest that the absorption of BCS Class III drugs is more influenced by their biopharmaceutic and physicochemical properties rather than the specific formulations or excipients used, indicating potential flexibility in formulation design for generic drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of the Similarity of Formulations and Excipients of Approved Generic Drug Products on In Vivo Bioequivalence for Putative Biopharmaceutics Classification System Class III Drugs. Ren, P., Chan, T., Yang, WC., et al.[2023]

The paper by Ono and Sugano suggests that biowaivers based on the Biopharmaceutics Classification System (BCS) could be used to evaluate the bioequivalence of orally disintegrating tablets (ODTs) compared to immediate release formulations for Class III drugs.

However, there are concerns that this approach has not been adequately tested with products that have different bioavailabilities, and it may overlook important factors such as the common way ODTs are taken (without water), which could affect gastric emptying and thus bioavailability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

On the BCS biowaivers of orally disintegrating tablets. García-Arieta, A., Gordon, J.[2017]

In a comprehensive review of 54 phase-I studies involving 1015 healthy volunteers over 10 years, the overall incidence of adverse events was found to be 12.8%, with a higher rate for active drugs (13.7%) compared to placebo (7.9%).

Most adverse events were minor, with only 3% classified as severe, and no deaths or life-threatening events reported, highlighting that while adverse events are common in phase-I trials, they are typically not serious.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in phase-I studies: a report in 1015 healthy volunteers. Sibille, M., Deigat, N., Janin, A., et al.[2019]

Oral bioavailability is crucial for understanding how food bioactive ingredients can provide health benefits, and factors like bioaccessibility and absorption significantly limit this process.

In vitro studies on oral bioavailability help food and drug manufacturers create better delivery systems and determine appropriate dosages of bioactive compounds to enhance health benefits while minimizing toxicity risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bioavailability and bioaccessibility of food bioactive compounds; overview and assessment by in vitro methods. Dima, C., Assadpour, E., Dima, S., et al.[2021]

Live Biotherapeutic Products (LBPs) have therapeutic potential by interacting with the microbiota and modulating host-microbiota relationships, but they face significant challenges in obtaining marketing authorization in the EU due to their unique safety assessment requirements.

A proposed roadmap for risk analysis and development programs is essential for LBPs, focusing on their specific characteristics and interactions with patients to ensure safety in non-clinical and early clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Live Biotherapeutic Products, A Road Map for Safety Assessment. Rouanet, A., Bolca, S., Bru, A., et al.[2023]

The study suggests that the AUC/dose ratio can predict the risk of bioinequivalence for oral drug products, indicating that this parameter is crucial for assessing the safety and efficacy of generic medications.

Data from six Japanese pharmaceutical companies showed that bioequivalence studies for BCS class 1 and class 3 drugs require a consistent number of subjects, supporting the idea that biowaivers could be appropriate for these drug classes, thus potentially streamlining the approval process for generic drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A perspective for biowaivers of human bioequivalence studies on the basis of the combination of the ratio of AUC to the dose and the biopharmaceutics classification system. Sakuma, S., Tachiki, H., Uchiyama, H., et al.[2011]

The study demonstrated that a new powder for oral suspension of lapatinib is bioequivalent to the standard 250-mg tablets, allowing for easier ingestion for patients with advanced cancer, with 144 participants involved in the trial.

No unexpected safety issues were reported, and the absorption rates of the two formulations were similar, indicating that the new formulation is both effective and safe for use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bioequivalence study with lapatinib powder for oral suspension and the original tablet formulation in cancer patients. Koch, KM., Ferron-Brady, G., Lemmon, C., et al.[2018]

In a survey of 459 members of the British Pharmacological Society, it was found that drugs were administered to 8163 healthy volunteers, with only 6.9% experiencing minor adverse effects and 0.04% facing potentially life-threatening effects, indicating a very low risk associated with these studies.

Among 7607 healthy student volunteers, only 6.0% reported minor adverse effects during drug administration for educational purposes, with no severe adverse effects noted, reinforcing the overall safety of drug administration in healthy volunteer studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthy volunteer studies in Great Britain: the results of a survey into 12 months activity in this field. Orme, M., Harry, J., Routledge, P., et al.[2019]

The EU council directives provide a comprehensive regulatory framework to ensure the safety of biotechnological medicinal products, focusing on benefit/risk evaluation and quality assessment.

The framework emphasizes the importance of preclinical safety and efficacy testing before new drug applications are approved, ensuring that new treatments are both safe and effective for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of biotechnological products. Bass, R., Purves, J., Amati, MP.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06741345

NCT06741345 | 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 ...

2. redjournal.org redjournal.org/article/S0360-3016(23)07845-8/fulltext

Multicenter Phase 1b/2a Clinical Trial of Radioprotectant ... Clinical trial of radioprotectant BIO 300 oral suspension for patients with non-small cell lung cancer receiving concurrent chemoradiotherapy.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0360301623078458

Multicenter Phase 1b/2a Clinical Trial of Radioprotectant ... We evaluated the clinical utility of BIO 300 Oral Suspension (BIO 300; synthetic genistein nanosuspension) in patients with NSCLC.

4. tandfonline.com tandfonline.com/doi/full/10.1080/09553002.2021.1981556

A novel oral formulation of BIO 300 confers prophylactic ... BIO 300 OP provided significant radioprotection against ionizing radiation in mice when administered twice per day for six days prior to total-body radiation ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02567799

NCT02567799 | BIO 300 Non-Small Cell Lung Cancer Study The purpose of this study is to determine the safety and effectiveness of BIO 300 Oral Suspension when used in combination with standard dose radiation therapy ...

6. nature.com nature.com/articles/s41598-022-17807-7

Pharmacokinetic and metabolomic studies with a BIO 300 ... This study affirms that administration of a single dose of up to 200 mg/kg of BIO 300 Oral Powder is safe in NHPs and conferred no metabolomic-mediated safety ...

7. globalbiodefense.com globalbiodefense.com/2024/10/03/humanetics-presents-bio-300-radiation-countermeasure-data-at-dod-scientific-meeting/

Humanetics Presents BIO 300 Radiation Countermeasure ... Humanetics provided an outline of clinical data supporting BIO 300's safety and efficacy, including the proposed plan for human dose conversion ...