Phase 1 BIO 300 Oral Suspension

Launched by HUMANETICS CORPORATION · Dec 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called BIO 300 Oral Suspension to understand its safety and how the body absorbs and processes it. The study is divided into two parts. In the first part, healthy adult volunteers will take different daily doses of the medication for 14 days while following a special diet and undergoing health checks. The goal is to see how safe the drug is and how it behaves in the body at different doses. In the second part, the trial will look at how eating food affects the way the drug is absorbed by the body. Participants will take the medication either after fasting or after a high-fat meal, and then switch conditions after a week.

To participate, individuals need to be healthy adults aged 18 to 64 with a body mass index (BMI) between 18 and 30. They should not be taking any medications or supplements for at least a week before starting the study. Participants will need to follow certain guidelines, like not consuming alcohol or specific foods, and women will have to take a pregnancy test before joining. Throughout the trial, participants can expect regular health checks and blood tests to ensure their safety and to gather important information about the drug. This study is important as it helps researchers learn more about BIO 300 and its effects, which could lead to future medical advancements.

Gender

ALL

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.