Acute Radiation SyndromePhase 1NCT04650555

BIO 300 Oral Powder Safety and Pharmacokinetics

A Phase 1 study testing BIO 300 Oral Powder in people with Acute Radiation Syndrome, run by Humanetics Corporation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Open-label, single ascending dose and multiple single dose study in healthy volunteers to evaluate the safety and pharmacokinetics of BIO 300 Oral Powder (BIO 300). The single ascending dose study consists of 4 ascending dose cohorts and the multiple single dose study consists of a single dose given daily for 6… Read more about this study

Who is it for?: Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for: Acute Radiation Syndrome
What is being tested?: BIO 300 Oral Powder
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 1 siteUnited States
Study dates: 8 Dec 2020to 6 Jul 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 64 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy adult non-smokers, 18-64 years old.
BMI 18-32 kg/m^2.
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 Cockcroft-Gault Equation.

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Adequate hematopoietic function as evidenced by white blood cells ≥ 3x10^9 / L and platelets ≥ 100x10^9 / L.
Female subjects of childbearing potential must have a negative pregnancy test within 72 hours of the start of treatment.
Subjects must agree to abstain from heterosexual intercourse or use a reliable method of contraception for 7 days after their last dose. Subjects using hormonal contraception are required to utilize condom/spermicide + additional barrier method for 7 days after their last dose.
Ability to read and provide written informed consent.
Subjects 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.

Who cannot join

Any prior use of the study test article.
Any clinically significant weight loss any time in prior 4 weeks at discretion of Investigator based on medical history interview.
Subjects 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);

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QTc with Fridericia's correction (QTcF) that is unmeasurable, or ≥ 480 msec on screening ECG. The average QTcF from the screening ECG (completed in triplicate) must be < 480 msec in order for the subject to be eligible for the study.
Subjects must not have had a clinically significant cardiac event such as myocardial infarction (within 6 months prior to the first dose of the study treatment); uncontrolled/symptomatic congestive heart failure (New York Heart Association (NYHA) classification of heart disease, Class III or IV, see Appendix 3) within 6 months before entry; or the presence of any other uncontrolled cardiovascular conditions [unstable hypertension at discretion of Investigator or arrhythmia, unstable angina pectoris, or severe valvular heart disease, etc.] that, in the opinion of the Investigator, increases the risk of ventricular arrhythmia.
Subjects with a history of arrhythmia (multifocal premature ventricular contractions (PVCs), bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation) which is symptomatic or requires treatment (CTCAE Grade 3) or asymptomatic sustained ventricular tachycardia are not eligible. Subjects with atrial fibrillation with well-controlled ventricular rate are eligible at the discretion of the Investigator.
Psychiatric conditions, social situations or substance abuse that precludes the ability of the subject 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. Illicit drugs, including THC, must be avoided from screen through the duration of the study.
Grade 2 or higher peripheral neuropathy.
Positive results for Hep B surface antigen, Hep C antibody, or HIV 1/2 antibody at screening visit.
Clinically significant immunodeficiency disorder in the opinion of the Investigator.
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception.
Women who are breastfeeding are not eligible for this study.
Subjects that are vegan, vegetarian or consume a soy-rich diet.
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.
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.
Treatment with another investigational drug within 30 days or 5 half-lives (whichever is longer) proceeding Day 1.
Positive drug screen or alcohol test at screen and day 1 predose.
Blood donation of approximately 1 pint (500 ml) or more within 60 days of day 1; plasma donations within 14 days of day 1. Subjects must agree not to donate blood or plasma for the duration of the study and for 30 days following end of study procedures.
Inability to swallow powdered medication followed with water.
History of sensitivity to heparin or heparin-induced thrombocytopenia.
Considered by the Investigator to be unsuitable to participate in the study for any other reason.

Trial locations and contacts

1 site in 1 country.

United States1 site

Nucleus Network, Ltd (Formally Prism Research, LLC)
Saint Paul, Minnesota, 55114

Other trials in United States

About this study

Official title: A Phase 1 Dose Escalation Trial Evaluating the Safety and Pharmacokinetic Profile of BIO 300 Oral Powder in Healthy Volunteers

Conditions: Acute Radiation Syndrome
Being tested: BIO 300 Oral Powder
Medical subject headings: Acute Radiation Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BIO 300 Oral PowderDrug
Also called BIO 300, Genistein
Amorphous solid dispersion of genistein milled into a powder

Study groups in NCT04650555
Study group	Role	What they receive
Single Ascending Dose Cohort 1	Experimental	500 mg BIO 300 Oral Powder administered as a single dose Receives: Drug: BIO 300 Oral Powder
Single Ascending Dose Cohort 2	Experimental	1000 mg BIO 300 Oral Powder, if dose escalation criteria met, administered as a single dose Receives: Drug: BIO 300 Oral Powder
Single Ascending Dose Cohort 3	Experimental	2000 mg BIO 300 Oral Powder, if dose escalation criteria met, administered as a single dose Receives: Drug: BIO 300 Oral Powder
Single Ascending Dose Cohort 4	Experimental	Single dose to be determined based on the safety and pharmacokinetic profiles in cohorts 1-3 Receives: Drug: BIO 300 Oral Powder
Multiple Single Dose Cohort 5	Experimental	Highest dose or maximum tolerated dose from the Single Ascending Dose study administered as a single dose given daily for 6 consecutive days Receives: Drug: BIO 300 Oral Powder

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse Events Related to BIO 300 Oral Powder
Evaluate the safety of single and multiple dose BIO 300 Oral Powder administration
Measured: Day 1 up to 1 week for Single Ascending Dose and Day 1 up to 2 weeks for Multiple Single Dose
Change in ECG QTc Interval
Measurement of the average QTc interval with Fridericia's correction (completed in triplicate at each timepoint)
Measured: Day 1 up to 1 week after the last dose for Single Ascending Dose and Multiple Single Dose Cohorts
Change in Clinical Laboratory Values
Monitoring of blood serum levels of albumin and total protein (all reported as g/dL)
Measured: Day 3 and 7 for Single Ascending Dose and Day 3, 6 and 13 for Multiple Single Dose
Change in Clinical Laboratory Values
Monitoring of blood serum levels of bicarbonate, chloride, potassium, and sodium (all reported as mEq/L)
Measured: Day 3 and 7 for Single Ascending Dose and Day 3, 6 and 13 for Multiple Single Dose
Change in Clinical Laboratory Values
Monitoring of blood serum levels of bilirubin (total and direct), BUN, calcium, cholesterol (total), creatinine, HDL, glucose, magnesium, phosphorous, triglycerides, and uric acid (all reported as mg/dL)
Measured: Day 3 and 7 for Single Ascending Dose and Day 3, 6 and 13 for Multiple Single Dose
Change in Clinical Laboratory Values
Monitoring of blood serum levels of alkaline phosphatase, ALT, amylase, AST, LDH, and lipase (all reported as IU/L)
Measured: Day 3 and 7 for Single Ascending Dose and Day 3, 6 and 13 for Multiple Single Dose
Area Under Curve of Genistein-Aglycone in Serum
Area under the curve of BIO 300 Oral Powder as assessed by analyzing serum concentrations of genistein-aglycone (free genistein) at multiple timepoints
Measured: Day 1 for the Single Ascending Dose and Day 6 for the Multiple Single Dose, prior to 1st dose then 0.5, 1, 2, 4, 6, 8, 12, 24, and 48 hours post dose and Day 1 Multiple Single Dose prior to dosing then 0.5, 1, 2, and 4 hours post dose

Secondary outcomes (1)

Number of Differentially Expressed Genes From Whole Blood Samples
The number of significantly differentially expressed genes detected in whole blood samples at various timepoints after BIO 300 Oral Powder dosing. Significant differential gene expression was defined as genes that have a mean absolute log2 fold change >2 with an adjusted p-value of <0.05 relative to baseline expression levels.
Measured: Day 1 for the Single Ascending Dose prior to dosing then 1, 2, 4, and 24 hours post dose and Day 1 Multiple Single Dose prior to dosing then 1, 2, and 4 hours post dose and and Day 6 prior to dosing then 4, 8, 12 and 24 hours post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Dec 20206 Jul 2021

First posted2 Dec 2020
Study start8 Dec 2020
Primary completion6 Jul 2021
Study completion6 Jul 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Acute Radiation SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04650555
Sponsor's protocol ID: CL0106-01
Status last verified: May 2024
First submitted: 19 Nov 2020
Last updated: 3 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Serebrenik AA, Verduyn CW, Kaytor MD. Safety, Pharmacokinetics, and Biomarkers of an Amorphous Solid Dispersion of Genistein, a Radioprotectant, in Healthy Volunteers. Clin Pharmacol Drug Dev. 2023 Feb;12(2):190-201. doi: 10.1002/cpdd.1188. Epub 2022 Oct 27.
PubMed 36301689

Study at a glance

From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Dose Escalation Trial Evaluating the Safety and Pharmacokinetic Profile of BIO 300 Oral Powder in Healthy Volunteers
ClinicalTrials.gov ID: NCT04650555
Acronym / sponsor ID: CL0106-01
Conditions: Acute Radiation Syndrome
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: Humanetics CorporationIndustry (pharma, biotech, devices)
Collaborators: United States Department of Defense, Joint Warfighter Medical Research Program
Study start: 8 Dec 2020 (actual)
Primary completion: 6 Jul 2021 (actual)
Study completion: 6 Jul 2021 (actual)
First posted: 2 Dec 2020 (actual)
Results: Posted 3 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Single Ascending Dose Cohort 1	Experimental	Drug: BIO 300 Oral Powder500 mg BIO 300 Oral Powder administered as a single dose
Single Ascending Dose Cohort 2	Experimental	Drug: BIO 300 Oral Powder1000 mg BIO 300 Oral Powder, if dose escalation criteria met, administered as a single dose
Single Ascending Dose Cohort 3	Experimental	Drug: BIO 300 Oral Powder2000 mg BIO 300 Oral Powder, if dose escalation criteria met, administered as a single dose
Single Ascending Dose Cohort 4	Experimental	Drug: BIO 300 Oral PowderSingle dose to be determined based on the safety and pharmacokinetic profiles in cohorts 1-3
Multiple Single Dose Cohort 5	Experimental	Drug: BIO 300 Oral PowderHighest dose or maximum tolerated dose from the Single Ascending Dose study administered as a single dose given daily for 6 consecutive days

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (12 listed)

Healthy adult non-smokers, 18-64 years old.
BMI 18-32 kg/m^2.
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.
Female subjects of childbearing potential must have a negative pregnancy test within 72 hours of the start of treatment.

Key exclusion criteria (25 listed)

Any prior use of the study test article.
Any clinically significant weight loss any time in prior 4 weeks at discretion of Investigator based on medical history interview.
Subjects with any of the following are not eligible;
Subjects must not have had a clinically significant cardiac event such as myocardial infarction (within 6 months prior to the first dose of the study treatment); uncontrolled/symptomatic congestive heart failure (New York Heart Association (NYHA) classification of heart disease, Class III or IV, see Appendix 3) within 6 months before entry; or the presence of any other uncontrolled cardiovascular conditions [unstable hypertension at discretion of Investigator or arrhythmia, unstable angina pectoris, or severe valvular heart disease, etc.] that, in the opinion of the Investigator, increases the risk of ventricular arrhythmia.
Subjects with a history of arrhythmia (multifocal premature ventricular contractions (PVCs), bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation) which is symptomatic or requires treatment (CTCAE Grade 3) or asymptomatic sustained ventricular tachycardia are not eligible. Subjects with atrial fibrillation with well-controlled ventricular rate are eligible at the discretion of the Investigator.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BIO 300 Oral PowderAlso: BIO 300, GenisteinAmorphous solid dispersion of genistein milled into a powder	Drug	Multiple Single Dose Cohort 5, Single Ascending Dose Cohort 1, Single Ascending Dose Cohort 2, Single Ascending Dose Cohort 3, Single Ascending Dose Cohort 4

Primary outcome

Adverse Events Related to BIO 300 Oral Powder
Time frame: Day 1 up to 1 week for Single Ascending Dose and Day 1 up to 2 weeks for Multiple Single Dose
Evaluate the safety of single and multiple dose BIO 300 Oral Powder administration
Change in ECG QTc Interval
Time frame: Day 1 up to 1 week after the last dose for Single Ascending Dose and Multiple Single Dose Cohorts
Measurement of the average QTc interval with Fridericia's correction (completed in triplicate at each timepoint)
Change in Clinical Laboratory Values
Time frame: Day 3 and 7 for Single Ascending Dose and Day 3, 6 and 13 for Multiple Single Dose
Monitoring of blood serum levels of albumin and total protein (all reported as g/dL)
Change in Clinical Laboratory Values
Time frame: Day 3 and 7 for Single Ascending Dose and Day 3, 6 and 13 for Multiple Single Dose
Monitoring of blood serum levels of bicarbonate, chloride, potassium, and sodium (all reported as mEq/L)
Change in Clinical Laboratory Values
Time frame: Day 3 and 7 for Single Ascending Dose and Day 3, 6 and 13 for Multiple Single Dose
Monitoring of blood serum levels of bilirubin (total and direct), BUN, calcium, cholesterol (total), creatinine, HDL, glucose, magnesium, phosphorous, triglycerides, and uric acid (all reported as mg/dL)
Change in Clinical Laboratory Values
Time frame: Day 3 and 7 for Single Ascending Dose and Day 3, 6 and 13 for Multiple Single Dose
Monitoring of blood serum levels of alkaline phosphatase, ALT, amylase, AST, LDH, and lipase (all reported as IU/L)
Area Under Curve of Genistein-Aglycone in Serum
Time frame: Day 1 for the Single Ascending Dose and Day 6 for the Multiple Single Dose, prior to 1st dose then 0.5, 1, 2, 4, 6, 8, 12, 24, and 48 hours post dose and Day 1 Multiple Single Dose prior to dosing then 0.5, 1, 2, and 4 hours post dose
Area under the curve of BIO 300 Oral Powder as assessed by analyzing serum concentrations of genistein-aglycone (free genistein) at multiple timepoints

1 secondary outcome

Number of Differentially Expressed Genes From Whole Blood Samples
Time frame: Day 1 for the Single Ascending Dose prior to dosing then 1, 2, 4, and 24 hours post dose and Day 1 Multiple Single Dose prior to dosing then 1, 2, and 4 hours post dose and and Day 6 prior to dosing then 4, 8, 12 and 24 hours post dose

Results and safety

Results posted to the registry on 3 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Single Ascending Dose Cohort 1	6	6
Single Ascending Dose Cohort 2	6	6
Single Ascending Dose Cohort 3	6	5
Single Ascending Dose Cohort 4	6	6
Multiple Single Dose Cohort 5	10	8

Primary outcome: Adverse Events Related to BIO 300 Oral Powder

Time frame: Day 1 up to 1 week for Single Ascending Dose and Day 1 up to 2 weeks for Multiple Single Dose. Number. Unit: Number of Adverse Events

Measure	Single Ascending Dose Cohort 1 n = 6	Single Ascending Dose Cohort 2 n = 6	Single Ascending Dose Cohort 3 n = 6	Single Ascending Dose Cohort 4 n = 6	Multiple Single Dose Cohort 5 n = 10
Dose Limiting Toxicities	–	0	0	0	0
Unlikely Treatment-Related Adverse Events	–	1	0	0	2
Possibly Treatment-Related Adverse Events	–	0	0	3	7
Probably Treatment-Related Adverse Events	–	4	4	0	15
Definitely Treatment-Related Adverse Events	–	0	0	2	1
Unrelated Adverse Event	–	0	0	1	1

Population analysed: No adverse events were reported for the Single Ascending Dose Cohort 1

Primary outcome: Change in ECG QTc Interval

Time frame: Day 1 up to 1 week after the last dose for Single Ascending Dose and Multiple Single Dose Cohorts. Mean (Standard Deviation). Unit: milliseconds

Measure	Single Ascending Dose Cohort 1 n = 6	Single Ascending Dose Cohort 2 n = 6	Single Ascending Dose Cohort 3 n = 6	Single Ascending Dose Cohort 4 n = 6	Multiple Single Dose Cohort 5 n = 10
Screening	407 (9.3)	402 (19.3)	416 (21.8)	415 (18.7)	413 (13.3)
4 Hours Post First Dose	412 (9.6)	407 (16.5)	419 (27.8)	420 (16.3)	417 (7.4)
24 Hours Post First Dose	407 (11.3)	400 (11.2)	402 (26.7)	404 (41.7)	413 (9.9)
1 Week Post Last Dose	408 (12.4)	401 (18.3)	416 (36.3)	414 (12.6)	415 (9.0)

Primary outcome: Change in Clinical Laboratory Values

Time frame: Day 3 and 7 for Single Ascending Dose and Day 3, 6 and 13 for Multiple Single Dose. Mean (Standard Deviation). Unit: g/dL

Measure	Single Ascending Dose Cohort 1 n = 6	Single Ascending Dose Cohort 2 n = 6	Single Ascending Dose Cohort 3 n = 6	Single Ascending Dose Cohort 4 n = 6	Multiple Single Dose Cohort 5 n = 8
Albumin Day 3	4.483 (0.204)	4.433 (0.393)	4.333 (0.367)	4.550 (0.187)	4.225 (0.349)
Albumin Day 6	–	–	–	–	4.475 (0.249)
Albumin Day 7	4.233 (0.216)	4.283 (0.279)	4.440 (0.241)	4.517 (0.117)	–
Albumin Day 13	–	–	–	–	4.475 (0.306)
Total Protein Day 3	6.667 (0.344)	6.833 (0.638)	6.500 (0.369)	6.650 (0.547)	6.363 (0.444)
Total Protein Day 6	–	–	–	–	6.788 (0.348)
Total Protein Day 7	6.417 (0.331)	6.850 (0.619)	6.520 (0.438)	6.717 (0.454)	–
Total Protein Day 13	–	–	–	–	6.550 (0.518)

Population analysed: Participants in the single ascending dose study were assessed on days 3 and 7 and participants in the multiple dose study were assessed on days 3, 6 and 13

Primary outcome: Change in Clinical Laboratory Values

Time frame: Day 3 and 7 for Single Ascending Dose and Day 3, 6 and 13 for Multiple Single Dose. Mean (Standard Deviation). Unit: mEq/L

Measure	Single Ascending Dose Cohort 1 n = 6	Single Ascending Dose Cohort 2 n = 6	Single Ascending Dose Cohort 3 n = 6	Single Ascending Dose Cohort 4 n = 6	Multiple Single Dose Cohort 5 n = 8
Bicarbonate Day 3	26.833 (1.722)	26.167 (0.753)	27.167 (2.401)	27.500 (1.049)	23.875 (2.850)
Bicarbonate Day 6	–	–	–	–	23.750 (1.165)
Bicarbonate Day 7	26.500 (1.871)	27.500 (1.761)	29.000 (0.707)	28.667 (1.751)	–
Bicarbonate Day 13	–	–	–	–	23.125 (1.246)
Chloride Day 3	104.5 (2.429)	104.0 (1.549)	104.7 (0.816)	103.5 (0.837)	105.5 (1.927)
Chloride Day 6	–	–	–	–	103.8 (2.252)
Chloride Day 7	104.3 (1.366)	104.5 (1.761)	104.2 (1.095)	104.8 (2.317)	–
Chloride Day 13	–	–	–	–	105.1 (0.835)

Population analysed: Analyzed on Day 3 and 7 for Single Ascending Dose and Day 3, 6 and 13 for Multiple Single Dose

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Screening to 1 week after the last dose of BIO 300 Oral Powder (up to 5 weeks). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single Ascending Dose Cohort 1	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Single Ascending Dose Cohort 2	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Single Ascending Dose Cohort 3	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Single Ascending Dose Cohort 4	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Multiple Single Dose Cohort 5	0 of 10 (0%)	8 of 10 (80%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 36301689Serebrenik AA, Verduyn CW, Kaytor MD. Safety, Pharmacokinetics, and Biomarkers of an Amorphous Solid Dispersion of Genistein, a Radioprotectant, in Healthy Volunteers. Clin Pharmacol Drug Dev. 2023 Feb;12(2):190-201. doi: 10.1002/cpdd.1188. Epub 2022 Oct 27.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael D Kaytor, Ph.D. principal investigator

Humanetics Corporation

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BIO 300 Oral Powder in people with Acute Radiation Syndrome, run by Humanetics Corporation at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events Related to BIO 300 Oral Powder (time frame: Day 1 up to 1 week for Single Ascending Dose and Day 1 up to 2 weeks for Multiple Single Dose). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04650555, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.