Trial · NCT04650555

BIO 300 Oral Powder Safety and Pharmacokinetics

NCT04650555, Phase 1, Completed, Humanetics Corporation; results first posted 2024-05-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. BIO 300 Oral Powder Safety and Pharmacokinetics. Trials, record NCT04650555. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04650555

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: BIO 300 Oral Powder Safety and Pharmacokinetics
NCT number: NCT04650555
Status: Completed
Phases: Phase 1
Enrollment: 34 participants, actual
Lead sponsor: Humanetics Corporation
Conditions: Acute Radiation Syndrome
Interventions: BIO 300 Oral Powder
First posted: 2020-12-02
Last updated: 2024-05-03
Results first posted: 2024-05-03

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Adverse Events Related to BIO 300 Oral Powder	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
Primary	Change in ECG QTc Interval	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)
Primary	Change in Clinical Laboratory Values	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)
Primary	Change in Clinical Laboratory Values	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)
Primary	Change in Clinical Laboratory Values	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)
Primary	Change in Clinical Laboratory Values	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)
Primary	Area Under Curve of Genistein-Aglycone in Serum	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
Secondary	Number of Differentially Expressed Genes From Whole Blood Samples	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	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.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Adverse Events Related to BIO 300 Oral Powder	Day 1 up to 1 week for Single Ascending Dose and Day 1 up to 2 weeks for Multiple Single Dose	No adverse events were reported for the Single Ascending Dose Cohort 1	Number of Adverse Events	NUMBER
PRIMARY	Change in ECG QTc Interval	Day 1 up to 1 week after the last dose for Single Ascending Dose and Multiple Single Dose Cohorts		milliseconds	MEAN
PRIMARY	Change in Clinical Laboratory Values	Day 3 and 7 for Single Ascending Dose and Day 3, 6 and 13 for Multiple Single Dose	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	g/dL	MEAN
PRIMARY	Change in Clinical Laboratory Values	Day 3 and 7 for Single Ascending Dose and Day 3, 6 and 13 for Multiple Single Dose	Analyzed on Day 3 and 7 for Single Ascending Dose and Day 3, 6 and 13 for Multiple Single Dose	mEq/L	MEAN
PRIMARY	Change in Clinical Laboratory Values	Day 3 and 7 for Single Ascending Dose and Day 3, 6 and 13 for Multiple Single Dose	Analyzed Day 3 and 7 for Single Ascending Dose and Day 3, 6 and 13 for Multiple Single Dose	mg/dL	MEAN
PRIMARY	Change in Clinical Laboratory Values	Day 3 and 7 for Single Ascending Dose and Day 3, 6 and 13 for Multiple Single Dose	Analyzed day 3 and 7 for Single Ascending Dose and Day 3, 6 and 13 for Multiple Single Dose	IU/L	MEAN
PRIMARY	Area Under Curve of Genistein-Aglycone in Serum	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 from 0 to 48 hours (AUC 0-48)	ng/mL*hr	MEAN
SECONDARY	Number of Differentially Expressed Genes From Whole Blood Samples	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	All participants had samples collected for RNA sequencing. Overall number of participants analyzed indicates the number of participants from each cohort that had samples analyzed by RNA sequencing.	Differentially expressed genes	NUMBER

Source ClinicalTrials.gov

Results by group345

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Adverse Events Related to BIO 300 Oral Powder	Single Ascending Dose Cohort 2	Dose Limiting Toxicities	0	Number of Adverse Events
Adverse Events Related to BIO 300 Oral Powder	Single Ascending Dose Cohort 3	Dose Limiting Toxicities	0	Number of Adverse Events
Adverse Events Related to BIO 300 Oral Powder	Single Ascending Dose Cohort 4	Dose Limiting Toxicities	0	Number of Adverse Events
Adverse Events Related to BIO 300 Oral Powder	Multiple Single Dose Cohort 5	Dose Limiting Toxicities	0	Number of Adverse Events
Adverse Events Related to BIO 300 Oral Powder	Single Ascending Dose Cohort 2	Unlikely Treatment-Related Adverse Events	1	Number of Adverse Events
Adverse Events Related to BIO 300 Oral Powder	Single Ascending Dose Cohort 3	Unlikely Treatment-Related Adverse Events	0	Number of Adverse Events
Adverse Events Related to BIO 300 Oral Powder	Single Ascending Dose Cohort 4	Unlikely Treatment-Related Adverse Events	0	Number of Adverse Events
Adverse Events Related to BIO 300 Oral Powder	Multiple Single Dose Cohort 5	Unlikely Treatment-Related Adverse Events	2	Number of Adverse Events
Adverse Events Related to BIO 300 Oral Powder	Single Ascending Dose Cohort 2	Possibly Treatment-Related Adverse Events	0	Number of Adverse Events
Adverse Events Related to BIO 300 Oral Powder	Single Ascending Dose Cohort 3	Possibly Treatment-Related Adverse Events	0	Number of Adverse Events

1 to 10 of 345Source ClinicalTrials.gov

See all 345 results by group

Participant flow15

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Single Ascending Dose Cohort 1	6
Overall Study	STARTED	Single Ascending Dose Cohort 2	6
Overall Study	STARTED	Single Ascending Dose Cohort 3	6
Overall Study	STARTED	Single Ascending Dose Cohort 4	6
Overall Study	STARTED	Multiple Single Dose Cohort 5	10
Overall Study	COMPLETED	Single Ascending Dose Cohort 1	6
Overall Study	COMPLETED	Single Ascending Dose Cohort 2	6
Overall Study	COMPLETED	Single Ascending Dose Cohort 3	5
Overall Study	COMPLETED	Single Ascending Dose Cohort 4	6
Overall Study	COMPLETED	Multiple Single Dose Cohort 5	8

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events80

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Palpitations	Cardiac disorders	Single Ascending Dose Cohort 1	0	6	0
other	Palpitations	Cardiac disorders	Single Ascending Dose Cohort 2	0	6	0
other	Palpitations	Cardiac disorders	Single Ascending Dose Cohort 3	0	6	0
other	Palpitations	Cardiac disorders	Single Ascending Dose Cohort 4	0	6	0
other	Palpitations	Cardiac disorders	Multiple Single Dose Cohort 5	1	10	1
other	Abdominal Pain	Gastrointestinal disorders	Single Ascending Dose Cohort 1	0	6	0
other	Abdominal Pain	Gastrointestinal disorders	Single Ascending Dose Cohort 2	0	6	0
other	Abdominal Pain	Gastrointestinal disorders	Single Ascending Dose Cohort 3	0	6	0
other	Abdominal Pain	Gastrointestinal disorders	Single Ascending Dose Cohort 4	0	6	0
other	Abdominal Pain	Gastrointestinal disorders	Multiple Single Dose Cohort 5	1	10	1

1 to 10 of 80Source ClinicalTrials.gov

See all 80 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Single Ascending Dose Cohort 1	0	6
Total, all-cause mortality	Single Ascending Dose Cohort 2	0	6
Total, all-cause mortality	Single Ascending Dose Cohort 3	0	6
Total, all-cause mortality	Single Ascending Dose Cohort 4	0	6
Total, all-cause mortality	Multiple Single Dose Cohort 5	0	10
Total, other adverse events	Single Ascending Dose Cohort 1	0	6
Total, other adverse events	Single Ascending Dose Cohort 2	4	6
Total, other adverse events	Single Ascending Dose Cohort 3	2	6
Total, other adverse events	Single Ascending Dose Cohort 4	5	6
Total, other adverse events	Multiple Single Dose Cohort 5	8	10

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
36301689	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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